The impact of an Implementation Strategy Bundle on the adoption of a combined lifestyle intervention in multiple community care settings: A hybrid type III stepped wedge implementation effectiveness trial

The impact of an Implementation Strategy Bundle on the adoption of a combined lifestyle intervention in multiple community care settings: A hybrid type III stepped wedge implementation effectiveness trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article The impact of an Implementation Strategy Bundle on the adoption of a combined lifestyle intervention in multiple community care settings: A hybrid type III stepped wedge implementation effectiveness trial Patricia J. van der Laag, Berber G Dorhout, Nicolaas PA Zuithoff, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8057231/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 7 You are reading this latest preprint version Abstract Background : ProMuscle is an evidence-based combined lifestyle intervention to promote physical functioning in community-dwelling older adults. To address identified barriers for the implementation of ProMuscle in community care settings, a theory and practice-based Implementation Strategy Bundle (ISB) was developed. The current study aims to investigate the impact of this ISB on the adoption of ProMuscle in multiple community care settings. Methods : A 42-week hybrid type III stepped-wedge randomized cluster implementation- effectiveness trial was conducted in Dutch community care. Participating healthcare professionals (i.e. physical therapists and dieticians) were allocated to one of five clusters based on their geographical location. The ISB targets multiple barriers (knowledge, costs, internal and external network) with multicomponent implementation strategies tailored to participants’ contexts using an online tool. Participants were trained to deliver ProMuscle and started the implementation as usual (i.e. without implementation support). Every six weeks one cluster transitioned to the intervention group. During this transitional period, participants gained access to the ISB. The primary outcome, adoption of ProMuscle, was measured on eight consecutive time points with the Provider REport of Sustainment Scale (PRESS). Adoption was analyzed with linear mixed models with random cluster effects and fixed time effects, corrected for gender and occupation. Secondly, reach, fidelity, acceptability, and feasibility of ProMuscle were evaluated over time as well as physical functioning outcomes of participating older adults. Results : Thirty healthcare professionals participated, data of 27 could be included for analysis. The intervention group showed a statistically non-significant increase of adoption of 0.32 (95% CI: -0.18-0.81; p=0.21) compared with the control group. After 42 weeks, 51% of the healthcare professionals had delivered ProMuscle, and fidelity of ProMuscle was higher in the intervention group than in the control group. Acceptability of ProMuscle significantly declined over time. Conclusion: The findings highlight the complexity of implementing combined lifestyle interventions such as ProMuscle in multiple community care settings. No significant effect of the ISB on the adoption was found. The results of this study suggest contextual factors likely influenced the implementation. Further exploration is needed into whether contextual factors moderated the impact of the ISB on the adoption of ProMuscle. Trial registration: ClinicalTrials.gov (NCT05672004) registered at 12/07/2022. Implementation stepped wedge cluster trial hybrid type III Implementation Strategy Bundle lifestyle intervention community care settings older adults healthcare professionals Figures Figure 1 Figure 2 Contributions to the literature This stepped-wedge cluster trial investigated the impact of an Implementation Strategy Bundle on the adoption, reach and fidelity of the ProMuscle lifestyle intervention for community-dwelling older adults. Adoption did not significantly increase. The significant decrease in acceptability of ProMuscle emphasizes the need of engagement and tailored support of professionals throughout the implementation. Low recruitment rates limited statistical analyses of reach and fidelity, highlighting challenges in recruitment of community-dwelling older adults. The potential influence of factors on the impact of the strategy bundle on the adoption, reach, and fidelity of ProMuscle illustrates the complexity of implementation trials across community-care settings. BACKGROUND The rapidly increasing number of older adults worldwide calls for implementing healthy aging initiatives to increase welfare of older adults and directly influence healthcare costs ( 1 ). For example, Evidence-Based Interventions (EBIs) that focus on maintaining physical independence in older adults have great potential in supporting and encouraging healthy aging ( 1 ). It is known that aging is associated with a decline in muscle mass and strength and ultimately can lead to a decrease in physical functioning, chronic diseases, and diminished quality of life ( 2 – 4 ). Because aging-related disabilities are multi-factorial, a multi-factorial approach is needed to counteract the decline in physical functioning. ProMuscle is an example of a multifactorial EBI combining resistance exercise training under supervision of a physical therapist and dietary protein intake supervised by a dietician aimed at maintaining physical independence in older adults ( 5 ). ProMuscle was found to be effective for improving muscle strength, body composition, and physical functioning in community-dwelling older adults ( 5 ) and shows great potential in managing the future health care system by enhancing older adults’ physical independence. However, to date, the implementation of EBIs such as ProMuscle and adoption by healthcare professionals (HCPs, i.e., physical therapists and dieticians) in community care remain low, and a small proportion of older adults are reached that could benefit from ProMuscle’s potential ( 6 ). In fact, it is known that only a minority of EBIs are implemented in daily healthcare. As a result, a significant number of innovations do not reach the impact they aim for. This phenomenon is also called the ‘research to practice gap.’ Implementation science seeks ways to address this research-to-practice gap ( 7 ). Developing, executing, and monitoring implementation strategies over time is the designated way to tackle barriers for implementation and enhance the uptake of an EBI in daily practice ( 7 – 10 ). However, to date, there is a lack of guidance about which strategies to use in which context for different EBIs ( 11 ). Only a few studies are available addressing effective strategies to enhance successful implementation of lifestyle EBIs in community-dwelling older adults. Therefore, the PUMP-fit study (2021–2025) aims to strengthen the knowledge base on the implementation of lifestyle EBIs specifically for this population. In the past years, we identified barriers and facilitators for the implementation of lifestyle EBIs like ProMuscle ( 12 ). Hereafter, a co-designed theory and practice-based Implementation Strategy Bundle (ISB) for professionals willing to implement ProMuscle was developed ( 13 ). This ISB addresses factors that can hinder the implementation of ProMuscle and similar EBIs, for instance, knowledge, costs, and network relations. Eventually, the ISB was processed into a web-based implementation toolbox, which facilitates HCPs to tailor the strategies to their context. In a pilot study, the ISB was found to be an acceptable and feasible way to support HCPs during the implementation process of ProMuscle ( 14 ). The current study primarily aims to investigate the impact of the Implementation Strategy Bundle (ISB) on the adoption of the EBI ProMuscle in multiple community care settings in the Netherlands. Secondly, fidelity, reach, acceptability, and feasibility of ProMuscle are evaluated over time as well as physical functioning outcomes of participating older adults. METHODS This study is part of the PUMP-fit study, which was performed in the region Foodvalley of the Netherlands. The total implementation process of the PUMP-fit study is guided by the Grol and Wensing Implementation of Change framework ( 15 ). Design A hybrid type III stepped-wedge randomized cluster implementation effectiveness trial was conducted. We chose a hybrid study design, evaluating primarily implementation outcomes and secondly patient outcomes, as we wanted to gain insight into the effectiveness of ProMuscle when implemented. Therefore, we collected outcomes from the recipients of ProMuscle as secondary outcomes in addition to implementation outcomes ( 16 , 17 ). A stepped wedge cluster trial was chosen because of the ability to compare between participants, but also within participants over time, as all participants started as controls and all participants subsequently received the ISB at standardized points in time ( 16 , 18 , 19 ). At last, a stepped wedge design is recommended if there is limited time and a small sample of professionals to recruit from in comparison to the total sample size that is needed to detect any effect ( 18 – 20 ). This study is reported following the CONSORT extension for stepped wedge cluster randomized trials ( 33 ) and the Standards for Reporting Implementation Studies (StaRi) checklist (additional file 1&2). The medical ethical committee of UMC Utrecht approved this study (22/050) and the study protocol was registered at ClinicalTrials.gov (NCT05672004). The current study took place between February 2023 and January 2024, with a total duration of 42 weeks. Setting and participants ProMuscle was implemented in different community care settings across the municipalities of the Region Foodvalley in the Netherlands. The Region Foodvalley consists of eight municipalities that collectively aim to speed up the transition to healthy and sustainable food supplies. Healthcare professionals HCPs, physical therapists and dieticians working in community care practices in the Region Foodvalley were the primary target population of this study. About 250 professionals work as physical therapists or dieticians in the Region Foodvalley. For this study, recruitment strategies of an earlier conducted pilot study ( 14 ) were intensified, resulting in recruitment through local networks, social media, and a personal invitation letter. Interested HCPs were informed about the study by email or by phone. To be eligible to participate in this study, HCPs must be: ( 1 ) physical therapist or dietician working in one of the communities in the Foodvalley in the Netherlands; ( 2 ) professionally involved in maintaining physical functioning in older adults; and ( 3 ) interested in lifestyle interventions for older adults. To prevent contamination, only one HCP per practice could be included as a representative for a practice. Eligible HCPs were asked in which practice they worked. If more than one HCPs working in one practice showed their interest in the study, they were asked to assign one HCP as a champion. All eligible HCPs signed informed consent prior to the start of the study. Recipients Older adults receiving the EBI ProMuscle were the secondary target population of the study. For the inclusion of older adults to ProMuscle, the in- and exclusion criteria of the original ProMuscle study were adopted ( 5 ). Older adults were eligible to participate in ProMuscle when they were; ( 1 ) aged 65 years or older; ( 2 ) living in one of the eight communities of the Foodvalley; ( 3 ) able to understand Dutch; ( 4 ) pre-frail or frail (score 1 or more points on the Fried frailty criteria) or reported loss of muscle strength ( 5 ). Older adults were excluded when they presented one or more contraindications for participating in progressive resistance exercise without consent of medical specialist or general practitioner. The EBI ProMuscle ProMuscle consists of two consecutive twelve-week programs. The first twelve weeks constituted the intensive part and contain resistance exercise group training twice a week under supervision of a physical therapist and three consultations with a dietician to ensure an optimal daily protein intake. The second twelve weeks were considered as follow-up to stimulate recipients to maintain their adapted lifestyle. Recipients are supported to perform comparable exercise activities in the neighborhood and maintain their optimal protein intake ( 5 , 21 ). Older adults could join the intervention any time during the study in a ProMuscle-licensed practice of choice. People could be referred to ProMuscle by, for instance, general practitioners or enter directly via advertisement. Recipients must pay to participate in ProMuscle, as ProMuscle is not reimbursed by health care insurances. Implementation Strategy Bundle (ISB) An ISB was recently developed to facilitate the implementation of the EBI ProMuscle in community care settings. Development took place in co-design with professionals, researchers, and implementation experts and was based on existing literature ( 13 ). In a first step, barriers and facilitators were identified by way of a scoping review ( 12 ). Second, identified barriers and facilitators were assigned to overarching themes that could influence the implementation of a lifestyle intervention for community-dwelling older adults. Namely, “assessing the context”, “knowledge”, “costs”, “network externally”, “internal network”, “champions”, and “patient needs and resources”. Hereafter, theory-based and practice informed implementation strategies were developed and translated into practical implementation activities in co-design with HCPs and implementation experts. In the end, each theme of the ISB consists of one to three multicomponent strategies. A complete description of the strategies in the ISB is presented per theme in additional file 3. Finally, the ISB was processed into a web-based implementation toolbox, which offers the ability to tailor strategies to HCPs’ context per theme and facilitates HCPs chronologically during their implementation process. Procedure Preparation phase After inclusion in the study, HCPs received an online ProMuscle training. During the training, HCPs were informed about the study and the preconditions to participate in the study (i.e. assigning a champion, arranging necessary materials, and approval of management to offer ProMuscle). Subsequently, to get insight into HCPs’ context-specific barriers for implementation, HCPs completed an implementation readiness assessment based on the readiness tool of Wandersman ( 22 ) and the Organizational Readiness assessment (ORIC) ( 23 ). The implementation readiness assessment consisted of 32 statements about the seven domains described by the CFIR framework (i.e, patient needs (5 statements), internal context (14 statements), characteristics of professionals (3 statements), characteristics of the intervention (5 statements), implementation process (1 statement), and external context (4 statements)). The statements are scored on a 5-point Likert scale. Mean scores per domain were calculated. A mean score of lower than 3 for a domain was hypothesized as a domain of concern, meaning HCPs should mainly focus on that domain(s) during the implementation. The readiness assessment is presented in additional file 4. The results of the implementation readiness assessment were used to tailor the ISB to HCPs’ individual contexts and needs during the implementation phase. Randomization Included HCPs, each of them connected to an unique practice, were allocated to one of five clusters based on the geographical location of their practice. The reason for clustering HCPs on geographical location was to prevent contamination between HCPs working in the same community ( 15 , 24 ). Because this study was conducted in a relatively small region, professionals from different practices were more likely to have mutual contact than when a study is conducted nationally. This increases the risk for contamination among practices. Besides, we wanted to prevent that a practice in one community benefits from the results of the ISB, for example, by improving their network and market value. Thus, clustering was on location of the practice a HCP worked in. Randomization took place at cluster level, i.e., the order in which the cluster transitioned to the intervention group. After all participants were allocated to a cluster, stratified randomization was conducted in an online tool to determine the time-point of transition to the intervention group during the implementation phase. Implementation phase HCPs were instructed to start the implementation of ProMuscle as usual without receiving implementation support. The ISB was sequentially rolled out over the five clusters. During the transitional period of 6 weeks in which clusters transitioned to the intervention group, HCPs were informed about the ISB and received their personal ISB tailored to the results of the implementation readiness assessment assessed in the preparation phase. Transitions from control group to intervention group continued 6-weekly until all clusters received the ISB. An overview of the implementation study design and number of participating HCPs per cluster at each time point is presented in Fig. 1 . Outcomes Implementation outcomes and intervention outcomes were measured with online questionnaires. Additionally, demographics of participating HCPs and recipients of ProMuscle were collected. Primary outcomes Implementation outcome The primary implementation outcome of the study was the adoption of ProMuscle among HCPs. Adoption is defined as HCPs’ intention to try or employ ProMuscle in their practice ( 25 ). In line with Damschroder et al. ( 26 ), we distinguished ‘adoptability’ as anticipated implementation outcome prior to implementation and ‘adoption’ as actual implementation outcome during and post-implementation. Adoptability was measured at baseline with the Measure of Innovation-Specific Implementation Intentions (MISII) ( 27 ). The MISII is a three-item questionnaire that measures the intention to adopt an evidence-based intervention with a 5-point Likert scale. At the following time points, adoption was measured with the Provider REport of Sustainment Scale (PRESS) ( 28 ). PRESS is a 3-item questionnaire that measures the continued use of an EBI on a 5-point Likert scale. For the MISII and PRESS a mean score of these items was calculated. There is no cut-off value known for the MISII and PRESS. Therefore, the research group decided that a mean score of three and higher was perceived as sufficient. The MISII and PRESS questionnaires are not yet available in Dutch and were therefore back- and forward-translated by an English native speaker. Secondary outcomes Implementation outcomes Secondary implementation outcomes were acceptability, feasibility, appropriateness, reach, and fidelity of ProMuscle measured on the HCPs level. Acceptability is the perception that the intervention is agreeable, pleasant, and satisfactory ( 25 ). Feasibility is the extent to which an intervention can be used in a specific context ( 25 ). Appropriateness is the perceived fit, relevance, or compatibility of ProMuscle ( 25 ). The acceptability, feasibility, and appropriateness of ProMuscle were measured on two time points (T0, T6) using the Dutch translation of the Acceptability of Intervention Measure (AIM), Feasibility of Intervention Measure (FIM) and Intervention Appropriateness Measure (IAM) ( 29 ). The AIM, FIM and IAM each consist of four statements that can be rated on a 5-point Likert scale: 1) completely disagree to 5) completely agree. The mean of the total score was calculated for each measure. The research group decided that a score of 3 and higher was perceived as acceptable, feasible, and appropriate. Earlier research of Weiner et al. showed that the questionnaires are valid and reliable measures ( 29 ). Reach was defined as the number of older adults who participated in ProMuscle ( 25 ). Reach was measured at all time points by HCPs’ self-report. The questionnaire contained two questions about the reach of ProMuscle: 1) “Did you deliver ProMuscle?” and 2) “How many older adults participated in ProMuscle?”. Fidelity of ProMuscle is the degree to which an intervention was implemented as prescribed ( 25 ). The number of activities described in the ProMuscle guideline were assessed with a self-report checklist based on this guideline. Intervention outcomes Patient outcomes on physical functioning were collected from recipients of ProMuscle to gain insight into the effectiveness of ProMuscle when implemented. If present in the medical file, measurements before and after ProMuscle of physical function outcomes of older adults were used for analyses ( 5 ). Measurements assessing physical functioning were in line with previous ProMuscle effectiveness studies ( 5 , 30 ) and included the repeated chair-rise test, Timed-Up-And-Go test (TUG), 1-repetition knee extension strength, and 1-Repetition Maximum (1RM) leg extension ( 30 ). Participant characteristics Baseline characteristics of the participating HCPs were collected using a questionnaire, including age (years), occupation (physical therapist/dietician), and gender (male/female/unknown). Characteristics of ProMuscle recipients (i.e. age, gender, length, education, living situation) were collected from the medical file. An overview of the assessed implementation outcomes, intervention outcomes, and participant demographics including the level of assessment, the corresponding measurements, and timing is presented in Table 1 . Table 1 Overview of outcome measurement per time point Timing of measurements HCP Recipients Outcome T0 TP T1 T2 T3 T4 T5 T6 T7 0 wks 12 wks D Characteristics of HCPs Questionnaire x D Characteristics of recipients Measurement HCP x I Adoption Questionnaire x* x x x x x x x I Acceptability ProMuscle Questionnaire x x I Appropriateness ProMuscle Questionnaire x x I Feasibility ProMuscle Questionnaire x x I Reach ProMuscle Questionnaire x x x x x x x I Fidelity ProMuscle Questionnaire x x x x x x x x I Implementation readiness Questionnaire x x x In Physical functioning older adults Measurement HCP x x Note: * = adoptability measured at T0 (MISII) instead of adoption (PRESS); D = demographics; I = implementation outcome; In = intervention outcome; TP = Transitional period Sample size The primary outcome for this study, the adoption of ProMuscle, was measured with the PRESS questionnaire ( 28 ). As there is little empirical data available to provide an estimate of the intervention’ effect on the primary outcome, an assumed effect size of 0.5 with a standard deviation of 1 was used. Sample size estimation was performed with the Shiny CRT app ( 31 ), with a significance level of 0.05 and power set at 0.80. We aimed for five sequences with one cluster per sequence receiving the intervention, resulting in a cluster size of 5 HCPs, representing 5 unique practices. Taking into account a drop-out of 20% during the study ( 32 ), a minimum sample size of 30 HCPs, divided over 5 clusters was considered. Statistical analysis Differences between clusters at baseline were analyzed with the Kruskall-Wallis test (degrees of freedom = 4) for continuous variables and the chi-square test for categorical variables to gain insight into possible differences between regions (i.e. clusters). Continuous variables were presented as mean and standard deviation (SD) or mean and standard error (SE). Categorical variables were presented as numbers (N) and percentages (%). Lastly, baseline characteristics of participating HCPs and recipients of ProMuscle were presented as descriptive statistics. Primary outcome Adoption of ProMuscle was analyzed with linear mixed model. A random intercept per cluster (to account for clustering of HCPs) and per subject (to account for time effects) was included. The effect of the intervention and differences over time were included in all models. In an additional step, gender and occupation were included as potential correction factors. Validity of the models, i.e. normality and homoscedasticity, was assessed by examining residuals. Differences within clusters over time were analyzed with linear mixed model, corrected for time, gender, and occupation with an interaction for cluster*timepoint. Secondary outcomes The implementation outcomes, acceptability, feasibility, and appropriateness of ProMuscle (measured at T0 and T6) were analyzed with linear mixed model. Correction for time and intervention effects was included to account for clustering and repeated measurements. Reach and fidelity of ProMuscle were compared between the control and the intervention group with generalized linear mixed model for binomial distributions for dichotomous outcomes and linear mixed model for continuous outcomes on reach. Both models accounted for clustering, similar to the analysis of the primary outcome. Physical functioning measurements of recipients before and after ProMuscle (0 weeks and 12 weeks) were assessed and presented as descriptive statistics. Sensitivity analysis A sensitivity analysis was conducted to assess the impact of missing data on the primary outcome. Multiple imputation by chained equations was applied with all variables from the analyses and included corrections for clustering as described for the analyses of the primary outcome. Significance level was set at p < 0.05. Analyses were conducted using SAS V9.4 for Windows (SAS Institute Inc., Cary, NC, USA) and SPSS version 29 (SPSS IMB Corp., USA). Multiple imputation was performed with the MICE, miceadds and pan packages in R (v4.4.2). RESULTS Participants Of the HCPs that responded to the invitation to participate, 35 were eligible to participate in this study. Nine HCPs eventually dropped out before the start of the study, resulting in a total of 26 HCPs that started the implementation study at T0. In the control period, one HCP entered and two dropped out, so 25 HCPs received the ISB during the transitional period. During the intervention period, two HCPs entered the study and two dropped out. In total 29 HCPs participated in this study, of whom 23 participated completely and six partly. Figure 1 presents the number of participants per cluster and time point. Most of the participants were female (76%) and more physical therapists (62%) than dieticians participated. Baseline measurements on implementation outcomes showed relatively high scores on adoptability, acceptability, and feasibility of ProMuscle. Besides gender, there were no significant differences between clusters. All participants scored higher than 96 (i.e. low readiness) on the implementation readiness assessment. The characteristics of the participants per cluster are described in Table 2 . Table 2 Characteristics of the participants (n = 26) at baseline. Presented as N (%) or Mean (standard deviation) Cluster 1 (N = 5) Cluster 2 (N = 6) Cluster 3 (N = 5) Cluster 4 (N = 5) Cluster 5 (N = 5) Total (N = 26) (%), Mean(SD) P Descriptive characteristics Occupation (physical therapist) 4 (57.14) 4 (66.67) 3 (60) 4 (66.67) 3 (60) 18 (62) 0.995 Age (years) 37.8 (SD:15.75) 48.60 (SD:11.92) 33.60 (SD:6.66) 41.00 (SD:16.27) 42.40 (SD:10.28) 40.62 (SD:12.47) 0.31 Gender (female) 2 (28.57) 6 (100) 5 (100) 4 (66.67) 5 (100) 22 (76) 0.01* Implementation outcomes Adoptability (range 1–5) 3.4 (SD:0.93) 3.8 (SD:0.87) 3.73 (SD:0.72) 3.08 (SD:0.32) 3.4 (SD:0.64) 3.5 (SD: 0.72) 0.62 Readiness (max score 160) 136.00 (SD:10.20) 132.80 (SD:13.61) 133.40 (SD:11.68) 115.25 (SD:12.97) 130.00 (SD:14.27) 130.08 (SD:13.46) 0.24 Acceptability (range 1–5) 4.45 (SD:0.57) 4.45 (SD:0.62) 4.25 (SD:0.47) 4.19 (SD:0.658) 4.25 (SD:0.56) 4.32 (SD: 0.53) 0.90 Feasibility (range 1–5) 3.65 (SD:0.42) 3.75 (SD:0.94) 3.4 (SD:0.45) 3.56 (SD:0.83) 4.0 (SD:0.64) 3.68 (SD: 0.65 0.69 Appropriateness (range 1–5) 4.15 (SD:0.55) 4.20 (SD:0.72) 3.95 (SD:0.21) 3.56 (SD:0.38) 4.15 (SD:0.49) 4.02 (SD: 0.50 0.34 *= significant difference P < 0.05 There was 30% missing data for the primary outcome adoption; missing data occurred mostly at later moments during the study. For two HCPs data was missing completely and were therefore excluded from the analysis, resulting in analysis for 27 HCPs with a total of 142 measurements over time for the primary outcome. Primary outcome Adoption of ProMuscle With a total mean of 3.5 (SD: 0.72), the adoptability among participants was sufficient. Overall, the intervention group showed a statistically non-significant increase of adoption with a mean difference of 0.32 (95% CI: -0.18–0.81; p = 0.21) compared with the control group after correction for potential confounders. However, differences in adoption between clusters varied and fluctuated over time, as presented in Fig. 2 . Cluster 1 increased their mean adoption from 1.14 (SE: 0.43) at T1 to 2.70 (SE: 0.54) at T7. The mean adoption of cluster 3 decreased from 2.04 (SE: 2.04) at baseline (T1) to 1.9 (SE: 0.40) at T7. Cluster 5 was the only cluster with an adoption score higher than 3 at T7 (3.06 SE: 0.45), other clusters’ mean scores on adoption varied between 1.80 and 2.84 at T7. Intracluster correlation without correction for confounders was 0.27. Secondary outcomes Acceptability, feasibility, and appropriateness of ProMuscle Acceptability of ProMuscle scored a mean of 4.33 (SE:0.14) at baseline. At the end of the study, the acceptability scores remained above 3 in every cluster, indicating that ProMuscle was still considered acceptable. Acceptability significantly decreased over time, with a mean difference of -0.30 (95% CI: -0.59 – -0.01; p = 0.04). Feasibility and appropriateness scored 3.7 (SE: 0.18) and 4.0 (SE: 0.16), respectively, at baseline. A significant decrease in both feasibility and appropriateness was observed in the intervention group compared with the control group, with a mean difference of -0.62 (95% CI 0.14–1.08; p = 0.01) for feasibility and − 0.68 (95% CI 0.30–1.06; p < 0.001) for appropriateness. Reach and fidelity of ProMuscle Reach and fidelity of ProMuscle are presented as descriptives as these outcomes could not be analyzed because of the low number of older adults participating in ProMuscle and HCPs that delivered ProMuscle. Concerning reach, in the intervention group, more HCPs delivered ProMuscle (51%) compared to the control group (34%). Due to unclear data concerning the reach, it was not possible to determine the exact number of older adults participating in ProMuscle. For example, HCPs answered the question “Did you deliver ProMuscle?” with yes but did not provide how many older adults participated in ProMuscle. Descriptives did show a higher fidelity of ProMuscle (100%) in the intervention group for physical therapists and dieticians compared to the control group (56% for the physical therapists, 50% for dieticians). Table 3 presents the mean change scores on secondary implementation outcomes (acceptability, feasibility, and appropriateness) between the control and intervention group as well as the descriptive data on reach and fidelity of ProMuscle. Table 3 Results of the mixed model analysis on acceptability, feasibility, and appropriateness presented as mean (standard error), and the results of reach and fidelity presented as N(%) between control and intervention group Outcome Time-point Control Intervention Mean difference (95% CI) P Acceptability (range 1–5) T0, T6 4.33 (SE: 0.14) 4.03 (SE: 0.14) -0.30 (-0.58 - -0.02) 0.04* Feasibility (range 1–5) T0, T6 3.69 (SE: 0.18) 3.08 (SE: 0.20) -0.62 (0.14–1.08) 0.01* Appropriateness (range 1–5) T0, T6 4.03 (SE: 0.15) 3.35 (SE: 0.16) -0.68 (0.30–1.06) 0.001* Reach (yes) N (%) T1-T7 16 ( 34 ) 27 ( 51 ) Fidelity N(%) T1-T7 PT Intake (yes) 5 (56) 12 (100) PT Frequency training (yes) 5 (56) 12 (100) PT intensify training (yes) 5 (56) 12 (100) PT Grouptraining (yes) 5 (56) 12 (100) PT use of fitness equipment (yes) 5 (83) 12 (100) DT Frequency yes 2 ( 50 ) 9 (100) *= significant difference between control and intervention group analyzed by Linear Mixed Model corrected for time; PT = physical therapist; DT = dietician Sensitivity analysis Sensitivity analysis was conducted to check if the results would be different when the data were complete. Multiple imputation was used to impute missing data. Due to the low number of participating older adults in ProMuscle, multiple imputation was not possible for missing data on fidelity and reach of ProMuscle. Results showed that there were no significant differences in adoption scores of ProMuscle when data were imputed (mean difference 0.31, 95% CI:-0.43-1.06; p = 0.41). For acceptability and feasibility of ProMuscle, the significant difference between T0 and T6 disappeared. The mean differences were − 0.28 (95% CI: -0.62-0.07; p = 0.11) for acceptability and − 0.45 (95% CI: -1.05-0.16; p = 0.13) for feasibility. Physical Functioning of Recipients Patient outcomes (n = 21) are presented as descriptive statistics in Table 4 . Older adults who participated in ProMuscle had a mean age of 72 years, the majority did not receive care (90%), and lived independently with their partner or children (81%). Visual interpretation of physical functioning outcomes shows an improvement on all measurements before and after participation in ProMuscle. Table 4 Patient outcomes of older adults participated in ProMuscle. Presented as mean (SD) or N (%). Patient outcomes (N = 21) Patient characteristics T0 Age 72.1 (SD: 6.56) Gender (male) 13 (61.9) Type of care None 19 (90.5) Partner 2 (9.5) Home situation Alone 4 ( 19 ) Together 17 (81) Education Low 1 (4.8) Intermediate 7 (33.3) High 3 (14.3) Length (cm) 169.44 (SD: 13.58) Physical functioning outcomes T0 T2 (12 weeks) 5 times sit to stand (sec) 10.25 (SD: 3.06) 8.36 (SD: 1.19) TUG (sec) 8.8 (SD: 3.54) 7.21 (SD: 2.92) 1RM Legpress (kg) 140.26 (SD: 58.0) 172.46 (SD: 82.95) 1RM Leg extension (kg) 47.15 (SD: 17.69) 71.17 (SD: 33.27) Weight (kg) 77.54 (SD: 14.61) 78.56 (SD: 14.99) DISCUSSION This hybrid type III stepped-wedge randomized cluster implementation-effectiveness trial aimed to evaluate the impact of the Implementation Strategy Bundle (ISB) on the adoption of ProMuscle, a lifestyle intervention for community-dwelling older adults. Results showed an increase in adoption in the intervention group compared to the control group. However, this increase was not statistically significant. To our knowledge, this is the first trial to investigate the effect of an ISB on the adoption of a lifestyle intervention for community-dwelling older adults among physical therapists and dieticians in multiple community care settings. Although an increase in adoption of ProMuscle by individual HCPs was observed over time, scores fluctuated, and no significant differences were found between groups. Most increases in adoption occurred directly after HCPs received the ISB and simultaneously with increasing reach rates. This may indicate a modest effect of the ISB on adoption and/or a relationship between adoption and reach of ProMuscle. Additionally, it is known that higher strategy fidelity tends to yield better clinical outcomes ( 34 ). In the current study, we were unable to assess the relationship between the ISB usage and the implementation outcomes adoption and reach of ProMuscle due to the limited number of participating recipients. However, a process evaluation conducted alongside this trial explored the use of the ISB in more depth. It can be suggested that the non-significant effect on adoption was due to inadequate use of the ISB, rather than its ineffectiveness ( 35 ). Further research should assess the relationship between adoption, reach, and ISB usage. The timing of ISB delivery could also have influenced the results. Timing is a known challenge in stepped wedge trials, where participants receive the intervention at fixed time points ( 36 ). In this study, some HCPs received the ISB as late as 36 weeks after baseline, and the number of missing data increased over time. However, analyses were corrected for timing, and the results remained unchanged following multiple imputation of the missing data. Additionally, characteristics of HCPs are a known contributor to the implementation of EBIs ( 37 ). At baseline, all HCPs scored relatively high on adoptability, indicating a high motivation to implement ProMuscle. According to the Diffusion of Innovation theory, five different categories of people can be characterized that adopt an innovation based on their willingness and adoption speed: innovators, early adopters, early majority, late majority, and laggards ( 37 ). Innovators are typically proactive, have an extensive network, have financial resources and knowledge, can handle uncertainties about an intervention, and are mostly the first to implement new ideas. Reflecting on the results of this study, participants could be characterized following the theory of Rogers. Three clusters showed relatively high adoptability and adoption scores at baseline (T0 and T1). Over time, the adoption of one cluster declined (cluster 3), while the other two clusters increased their adoption and reach. It can be suggested that characteristics played a role in the implementation, as the HCPs in these two clusters were mainly older, had more work experience, and were probably innovators with experience in implementing innovations. For this group the ISB could be sufficient, as innovators are most likely familiar with the actions needed for implementation and are aware of potential barriers that could influence the implementation. In contrast, HCPs with less experience in implementation (e.g. early majority, late majority, and laggards) may need more personalized support to increase the adoption of ProMuscle ( 38 ). The long-term goal of the PUMP-fit implementation study is to sustain the implementation support when the researchers withdraw from the implementation study. To achieve this, HCPs must remain motivated to implement ProMuscle. In a previous process evaluation, HCPs evaluated the lifestyle intervention ProMuscle as valuable and acceptable ( 4 ). Similarly, the relatively high baseline scores in this study suggest that HCPs believed ProMuscle fits their practice and current demand for care. Remarkably, except for one cluster (cluster 5), this study showed a significant decrease in acceptability, feasibility, and appropriateness of ProMuscle over time. Despite this decline, scores remained above the moderate threshold of 3. However, the decrease in acceptability warrants further exploration. One possible explanation could be the timing within this trial’ design. As mentioned earlier, Caille et al. ( 36 ) described that the effect of an intervention can change over time in stepped wedge trials. In our analysis we corrected for time to account for possible interaction with the intervention’s effect. Moreover, we assessed if the effect of the ISB varied over time. Although no significant interaction was found, the results of this analysis should be interpreted with caution due to limited sample size and statistical power. Another possible explanation for the decrease in acceptability is that the motivation of HCPs dropped during the study, particularly when the implementation was not as successful as expected. High acceptability among HCPs is likely associated with successful implementation of ProMuscle. This is supported by the results of this study and the process evaluation of van Dongen et al ( 4 ). Therefore, it is important to ensure engagement and motivation of HCPs throughout the implementation and sustainment. Support by way of an online-provided ISB may not be sufficient, some HCPs may require active encouragement. For example, education is a known and widely used implementation strategy for changing behavior and increasing motivation and knowledge ( 35 ). Further exploration of drivers and possibilities to increase the impact of the ISB could be assessed in a process evaluation. Similar implementation trials ( 39 – 42 ) that “failed” to show effects or showed mixed effects of a strategy bundle on implementation suggest that contextual factors may have influenced the effect of the strategy bundle ( 43 – 46 ). As highlighted by multiple authors ( 47 , 48 ), the complex process of implementation involves a various range of actors across multiple system levels. Particularly, when aiming for sustainment and scale-up, different factors on different levels (i.e. inner setting, process, intervention characteristics, and outer setting) need to be considered ( 49 ). In the case of ProMuscle, implemented across multiple care settings, contextual factors at organizational and policy-level, such as external leadership, funding environment, values, needs, and priorities of stakeholders ( 49 ) could have influenced the impact of the ISB on the adoption of ProMuscle. These outer-setting contextual factors were not extensively addressed by the ISB. First, these factors were not identified by literature and HCPs during the development of the ISB. Secondly, this study focused on a small-scale implementation, whereas such contextual factors are more commonly addressed in scale-up studies. Moreover, addressing contextual factors on organizational or policy-level could be challenging for individual HCPs. This highlights the need for future studies to consider the possible effect of outer-setting contextual factors, even for smaller-scale implementation initiatives and earlier implementation phases ( 35 , 50 , 51 ). Additionally, the complexity of implementation shows a need for models and frameworks to identify factors for the success of the implementation ( 43 , 52 ), the process, and the working mechanism of a strategy or multiple strategies. Understanding why the ISB was not successful and how it could be successful in implementing a lifestyle EBI like ProMuscle( 53 ) is essential for successful scale-up of ProMuscle and generalization of results to other contexts (Geng). Methodological considerations Some methodological considerations should be made. A strength of this study is the use of a stepped-wedge design to assess the impact of the ISB on the adoption of ProMuscle. This design is particularly suitable in small sample size studies and regional contexts ( 18 – 20 ). The design prevents contamination between HCPs working in the same community ( 24 ). Moreover, the ISB was accessible to all HCPs in the Foodvalley, supporting equitable implementation support. Some limitations could be mentioned. First, missing data increased over time, with 30% of data missing at the end of the study. Sensitivity analysis using multiple imputations was conducted to account for the missing data. Results did not show a difference in the results of the original data, indicating that the missing data did not bias the results. Second, the sample size in our study was relatively small. Approximately 16% of the invited HCPs participated (n = 30) in this study. This response rate aligns with other studies ( 41 ) and we reached the predetermined minimal sample size of 25 HCPs. However, a larger sample could have increased statistical power, improved corrections for time and variability of context, and may have enhanced the ability to detect a significant effect of the ISB on adoption. Moreover, a larger sample size could also improve the generalization of results to other contexts or lifestyle interventions. Third, because of the low reach of ProMuscle, we were unable to analyze fidelity and intervention outcomes on physical functioning. However, in prior work, Dorhout et al. showed that ProMuscle remains effective in improving physical functioning and muscle strength in implementation settings ( 30 ). Lastly, the PRESS may not have been the ideal measurement to measure adoption among HCPs. Although adoption increased over time, the change was insufficient to detect significant differences between groups. The trials’ protocol hypothesized an effect size of 0.5. While most clusters in this study showed an increase of more than 0.5, the overall mean change was 0.3. This raises questions about the cut-off value and the potential presence of a ceiling effect. Moreover, some HCPs reported high adoption scores despite having zero reach, suggesting a disconnect between intention and actual implementation. While the definition of adoption in this study was based on intention to use ProMuscle ( 25 ), this discrepancy highlights the need for consensus on implementation outcome definitions and the development of more valid tools to capture adoption in real-world settings. Implications Overall, these findings highlight the complexity of implementing evidence-based interventions in real-world settings and emphasize the need for adaptable, context-aware strategies ( 50 ). Current implementation taxonomies do not fully account for the complexity of implementation and the multiple system-level factors and contexts ( 48 ). The results of this study suggest that individual characteristics may affect the adoption of a lifestyle intervention in multiple community care settings. Moreover, based on earlier research on sustainment and upscaling, EBIs’ contextual factors on organizational and policy-level could have contributed to the ISB’ impact on adoption. Given the complexity and variety of factors influencing the implementation, it seems necessary to employ multi-faceted or strategy bundles like we used in the current study. It also raises the question if real-world implementation may outweigh the theoretical need to assess individual strategy effectiveness ( 35 ). There is a need for further understanding of how strategies can be tailored to specific contexts, which (combination of) strategies could be effective in real-world implementation of EBIs, and how strategies should be deployed ( 52 ). CONCLUSION This stepped wedge cluster trial did not demonstrate a statistically significant effect of an Implementation Strategy Bundle on the adoption of the evidence-based lifestyle intervention ProMuscle for community-dwelling older adults among HCPs. Moreover, the results revealed a significant decline in acceptability of ProMuscle and low reach rates over time. The results of this study highlight the complexity of implementing lifestyle EBIs across multiple community care settings. It shows that the effectiveness of implementation support can depend on the needs and skills of HCPs. Moreover, contextual factors likely influenced the implementation and the ISB’s effect on adoption. Further exploration is warranted to determine whether and how contextual factors influenced the implementation and moderated the impact of the ISB on the adoption of ProMuscle. Gaining insights into the complex dynamics of implementation is essential for informing strategies to enhance real-world adoption, sustainment, and scale-up of EBIs in community-care settings. Abbreviations ISB = Implementation Strategy Bundle HCP = HealthCare Professional EBI = Evidence Based Intervention Declarations Ethics approval and consent to participate: All participants gave written consent for participation in this trial. The Medical Ethical Committee of the University Medical Center Utrecht approved this study (22/050) Consent for publication: not applicable Availability of data and materials: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. Competing interests: The authors declare that they have no competing interests. Funding: The research described in this paper was financially supported by a grant from the Regiodeal Foodvalley (162135) Authors' contributions: B.D and PL set up the study under supervision of DB. P.L. was the contact person for the participating professionals. P.L., collected and analyzed data from surveys. P.Z. and P.L. conducted the LMM analyses and MI of the primary outcomes. P.L. wrote the manuscript. B.D., D.B., C.V., L.S., P.Z. provided feedback and input for the analysis of the data, critically read, and provided feedback for the manuscript. 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Standards for Reporting Implementation Studies: the StaRI checklist for completion Additionalfile3ISB..docx Additional file 3. .docx description of implementation strategies following Proctor recommendation for specifying and reporting implementation strategies. Additionalfile4.readiness.docx Additional file 4. .docx Readiness Assessment – English Translation Cite Share Download PDF Status: Under Review Version 1 posted Reviews received at journal 06 Apr, 2026 Reviewers agreed at journal 24 Mar, 2026 Reviewers agreed at journal 02 Dec, 2025 Reviewers invited by journal 02 Dec, 2025 Editor assigned by journal 01 Dec, 2025 Submission checks completed at journal 19 Nov, 2025 First submitted to journal 07 Nov, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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07:07:38","extension":"html","order_by":18,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":185987,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-8057231/v1/f72582811f47dc5639256f12.html"},{"id":97654997,"identity":"a8f11480-7c98-488b-b2d8-ac6b7f3abcb4","added_by":"auto","created_at":"2025-12-08 07:07:37","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":227858,"visible":true,"origin":"","legend":"\u003cp\u003ePUMP-fit hybrid type III stepped-wedge randomized cluster implementation- effectiveness trial design and number of participating HCPs\u003c/p\u003e\n\u003cp\u003eBlue cells represent the control group = Implementation as usual\u003c/p\u003e\n\u003cp\u003eWhite cells = Transitional period in which HCP received the ISB\u003c/p\u003e\n\u003cp\u003eGreen cells represent the intervention group = Implementation Strategy Bundle\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-8057231/v1/de33957d1b599a1d5abd32bf.jpeg"},{"id":97672976,"identity":"3f770ed4-d2bd-47d9-90af-d2f849f5831e","added_by":"auto","created_at":"2025-12-08 09:39:09","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":164188,"visible":true,"origin":"","legend":"\u003cp\u003eMean adoption over time per cluster.\u003c/p\u003e\n\u003cp\u003e▶ = moment a cluster received the ISB and transitioned to the intervention group\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-8057231/v1/655f4a6194c93d0bf9fb42eb.png"},{"id":97678813,"identity":"3d1b00a8-bca3-4810-8174-ae20dd55715d","added_by":"auto","created_at":"2025-12-08 09:56:14","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1636715,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8057231/v1/5b8fc062-92a7-4911-aca4-230fde6ca2a3.pdf"},{"id":97655001,"identity":"c9cbcf2f-f631-4453-a0d3-cb9f85d556c9","added_by":"auto","created_at":"2025-12-08 07:07:37","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":33807,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eAdditional files\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAdditional file 1.\u003c/p\u003e\n\u003cp\u003eDocx.\u003c/p\u003e\n\u003cp\u003eCONSORT 2025 Checklist: updated guideline for reporting randomised trials\u003c/p\u003e","description":"","filename":"Additionalfile1.CONSORTchecklist.docx","url":"https://assets-eu.researchsquare.com/files/rs-8057231/v1/7248b946957c61ed4d8d1644.docx"},{"id":97655003,"identity":"f4b5a552-5fbc-43ba-8d18-86787fefc365","added_by":"auto","created_at":"2025-12-08 07:07:37","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":81757,"visible":true,"origin":"","legend":"\u003cp\u003eAdditional file 2.\u003c/p\u003e\n\u003cp\u003eDocx.\u003c/p\u003e\n\u003cp\u003eStandards for Reporting Implementation Studies: the StaRI checklist for completion\u003c/p\u003e","description":"","filename":"Additionalfile2.Starichecklist.docx","url":"https://assets-eu.researchsquare.com/files/rs-8057231/v1/5a0067114724e1858460ced7.docx"},{"id":97674643,"identity":"86e9e27d-4799-4c0f-97e4-d8e7c0306624","added_by":"auto","created_at":"2025-12-08 09:43:47","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":148815,"visible":true,"origin":"","legend":"\u003cp\u003eAdditional file 3.\u003c/p\u003e\n\u003cp\u003e.docx\u003c/p\u003e\n\u003cp\u003edescription of implementation strategies following Proctor recommendation for specifying and reporting implementation strategies.\u003c/p\u003e","description":"","filename":"Additionalfile3ISB..docx","url":"https://assets-eu.researchsquare.com/files/rs-8057231/v1/3751b2453a327dfdb10c00a7.docx"},{"id":97674259,"identity":"7db0c6e1-c052-4de8-8704-d83b8be32f97","added_by":"auto","created_at":"2025-12-08 09:42:48","extension":"docx","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":18136,"visible":true,"origin":"","legend":"\u003cp\u003eAdditional file 4.\u003c/p\u003e\n\u003cp\u003e.docx\u003c/p\u003e\n\u003cp\u003eReadiness Assessment – English Translation\u003c/p\u003e","description":"","filename":"Additionalfile4.readiness.docx","url":"https://assets-eu.researchsquare.com/files/rs-8057231/v1/411c9b198101c8308359b77d.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"The impact of an Implementation Strategy Bundle on the adoption of a combined lifestyle intervention in multiple community care settings: A hybrid type III stepped wedge implementation effectiveness trial","fulltext":[{"header":"Contributions to the literature","content":"\u003cul\u003e\n \u003cli\u003eThis stepped-wedge cluster trial investigated the impact of an Implementation Strategy Bundle on the adoption, reach and fidelity of the ProMuscle lifestyle intervention for community-dwelling older adults.\u003c/li\u003e\n \u003cli\u003eAdoption did not significantly increase. The significant decrease in acceptability of ProMuscle emphasizes the need of engagement and tailored support of professionals throughout the implementation.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eLow recruitment rates limited statistical analyses of reach and fidelity, highlighting challenges in recruitment of community-dwelling older adults.\u003c/li\u003e\n \u003cli\u003eThe potential influence of factors on the impact of the strategy bundle on the adoption, reach, and fidelity of ProMuscle illustrates the complexity of implementation trials across community-care settings.\u0026nbsp;\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"BACKGROUND","content":"\u003cp\u003eThe rapidly increasing number of older adults worldwide calls for implementing healthy aging initiatives to increase welfare of older adults and directly influence healthcare costs (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). For example, Evidence-Based Interventions (EBIs) that focus on maintaining physical independence in older adults have great potential in supporting and encouraging healthy aging (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). It is known that aging is associated with a decline in muscle mass and strength and ultimately can lead to a decrease in physical functioning, chronic diseases, and diminished quality of life (\u003cspan additionalcitationids=\"CR3\" citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). Because aging-related disabilities are multi-factorial, a multi-factorial approach is needed to counteract the decline in physical functioning.\u003c/p\u003e\u003cp\u003eProMuscle is an example of a multifactorial EBI combining resistance exercise training under supervision of a physical therapist and dietary protein intake supervised by a dietician aimed at maintaining physical independence in older adults (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). ProMuscle was found to be effective for improving muscle strength, body composition, and physical functioning in community-dwelling older adults (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e) and shows great potential in managing the future health care system by enhancing older adults\u0026rsquo; physical independence. However, to date, the implementation of EBIs such as ProMuscle and adoption by healthcare professionals (HCPs, i.e., physical therapists and dieticians) in community care remain low, and a small proportion of older adults are reached that could benefit from ProMuscle\u0026rsquo;s potential (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eIn fact, it is known that only a minority of EBIs are implemented in daily healthcare. As a result, a significant number of innovations do not reach the impact they aim for. This phenomenon is also called the \u0026lsquo;research to practice gap.\u0026rsquo; Implementation science seeks ways to address this research-to-practice gap (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). Developing, executing, and monitoring implementation strategies over time is the designated way to tackle barriers for implementation and enhance the uptake of an EBI in daily practice (\u003cspan additionalcitationids=\"CR8 CR9\" citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). However, to date, there is a lack of guidance about which strategies to use in which context for different EBIs (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eOnly a few studies are available addressing effective strategies to enhance successful implementation of lifestyle EBIs in community-dwelling older adults. Therefore, the PUMP-fit study (2021\u0026ndash;2025) aims to strengthen the knowledge base on the implementation of lifestyle EBIs specifically for this population. In the past years, we identified barriers and facilitators for the implementation of lifestyle EBIs like ProMuscle (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). Hereafter, a co-designed theory and practice-based Implementation Strategy Bundle (ISB) for professionals willing to implement ProMuscle was developed (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). This ISB addresses factors that can hinder the implementation of ProMuscle and similar EBIs, for instance, knowledge, costs, and network relations. Eventually, the ISB was processed into a web-based implementation toolbox, which facilitates HCPs to tailor the strategies to their context. In a pilot study, the ISB was found to be an acceptable and feasible way to support HCPs during the implementation process of ProMuscle (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). The current study primarily aims to investigate the impact of the Implementation Strategy Bundle (ISB) on the adoption of the EBI ProMuscle in multiple community care settings in the Netherlands. Secondly, fidelity, reach, acceptability, and feasibility of ProMuscle are evaluated over time as well as physical functioning outcomes of participating older adults.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cp\u003eThis study is part of the PUMP-fit study, which was performed in the region Foodvalley of the Netherlands. The total implementation process of the PUMP-fit study is guided by the Grol and Wensing Implementation of Change framework (\u003cspan class=\"CitationRef\"\u003e15\u003c/span\u003e).\u003c/p\u003e\n\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\n \u003ch2\u003eDesign\u003c/h2\u003e\n \u003cp\u003eA hybrid type III stepped-wedge randomized cluster implementation effectiveness trial was conducted. We chose a hybrid study design, evaluating primarily implementation outcomes and secondly patient outcomes, as we wanted to gain insight into the effectiveness of ProMuscle when implemented. Therefore, we collected outcomes from the recipients of ProMuscle as secondary outcomes in addition to implementation outcomes (\u003cspan class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e). A stepped wedge cluster trial was chosen because of the ability to compare between participants, but also within participants over time, as all participants started as controls and all participants subsequently received the ISB at standardized points in time (\u003cspan class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eAt last, a stepped wedge design is recommended if there is limited time and a small sample of professionals to recruit from in comparison to the total sample size that is needed to detect any effect (\u003cspan class=\"CitationRef\"\u003e18\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e20\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eThis study is reported following the CONSORT extension for stepped wedge cluster randomized trials (\u003cspan class=\"CitationRef\"\u003e33\u003c/span\u003e) and the Standards for Reporting Implementation Studies (StaRi) checklist (additional file 1\u0026amp;2). The medical ethical committee of UMC Utrecht approved this study (22/050) and the study protocol was registered at ClinicalTrials.gov (NCT05672004).\u003c/p\u003e\n \u003cp\u003eThe current study took place between February 2023 and January 2024, with a total duration of 42 weeks.\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eSetting and participants\u003c/h3\u003e\n\u003cp\u003eProMuscle was implemented in different community care settings across the municipalities of the Region Foodvalley in the Netherlands. The Region Foodvalley consists of eight municipalities that collectively aim to speed up the transition to healthy and sustainable food supplies.\u003c/p\u003e\n\u003ch3\u003eHealthcare professionals\u003c/h3\u003e\n\u003cp\u003eHCPs, physical therapists and dieticians working in community care practices in the Region Foodvalley were the primary target population of this study. About 250 professionals work as physical therapists or dieticians in the Region Foodvalley. For this study, recruitment strategies of an earlier conducted pilot study (\u003cspan class=\"CitationRef\"\u003e14\u003c/span\u003e) were intensified, resulting in recruitment through local networks, social media, and a personal invitation letter. Interested HCPs were informed about the study by email or by phone.\u003c/p\u003e\n\u003cp\u003eTo be eligible to participate in this study, HCPs must be: (\u003cspan class=\"CitationRef\"\u003e1\u003c/span\u003e) physical therapist or dietician working in one of the communities in the Foodvalley in the Netherlands; (\u003cspan class=\"CitationRef\"\u003e2\u003c/span\u003e) professionally involved in maintaining physical functioning in older adults; and (\u003cspan class=\"CitationRef\"\u003e3\u003c/span\u003e) interested in lifestyle interventions for older adults. To prevent contamination, only one HCP per practice could be included as a representative for a practice. Eligible HCPs were asked in which practice they worked. If more than one HCPs working in one practice showed their interest in the study, they were asked to assign one HCP as a champion. All eligible HCPs signed informed consent prior to the start of the study.\u003c/p\u003e\n\u003ch3\u003eRecipients\u003c/h3\u003e\n\u003cp\u003eOlder adults receiving the EBI ProMuscle were the secondary target population of the study. For the inclusion of older adults to ProMuscle, the in- and exclusion criteria of the original ProMuscle study were adopted (\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e). Older adults were eligible to participate in ProMuscle when they were; (\u003cspan class=\"CitationRef\"\u003e1\u003c/span\u003e) aged 65 years or older; (\u003cspan class=\"CitationRef\"\u003e2\u003c/span\u003e) living in one of the eight communities of the Foodvalley; (\u003cspan class=\"CitationRef\"\u003e3\u003c/span\u003e) able to understand Dutch; (\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e) pre-frail or frail (score 1 or more points on the Fried frailty criteria) or reported loss of muscle strength (\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e). Older adults were excluded when they presented one or more contraindications for participating in progressive resistance exercise without consent of medical specialist or general practitioner.\u003c/p\u003e\n\u003ch3\u003eThe EBI ProMuscle\u003c/h3\u003e\n\u003cp\u003eProMuscle consists of two consecutive twelve-week programs. The first twelve weeks constituted the intensive part and contain resistance exercise group training twice a week under supervision of a physical therapist and three consultations with a dietician to ensure an optimal daily protein intake. The second twelve weeks were considered as follow-up to stimulate recipients to maintain their adapted lifestyle. Recipients are supported to perform comparable exercise activities in the neighborhood and maintain their optimal protein intake (\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e21\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eOlder adults could join the intervention any time during the study in a ProMuscle-licensed practice of choice. People could be referred to ProMuscle by, for instance, general practitioners or enter directly via advertisement. Recipients must pay to participate in ProMuscle, as ProMuscle is not reimbursed by health care insurances.\u003c/p\u003e\n\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\n \u003ch2\u003eImplementation Strategy Bundle (ISB)\u003c/h2\u003e\n \u003cp\u003eAn ISB was recently developed to facilitate the implementation of the EBI ProMuscle in community care settings. Development took place in co-design with professionals, researchers, and implementation experts and was based on existing literature (\u003cspan class=\"CitationRef\"\u003e13\u003c/span\u003e). In a first step, barriers and facilitators were identified by way of a scoping review (\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e). Second, identified barriers and facilitators were assigned to overarching themes that could influence the implementation of a lifestyle intervention for community-dwelling older adults. Namely, \u0026ldquo;assessing the context\u0026rdquo;, \u0026ldquo;knowledge\u0026rdquo;, \u0026ldquo;costs\u0026rdquo;, \u0026ldquo;network externally\u0026rdquo;, \u0026ldquo;internal network\u0026rdquo;, \u0026ldquo;champions\u0026rdquo;, and \u0026ldquo;patient needs and resources\u0026rdquo;. Hereafter, theory-based and practice informed implementation strategies were developed and translated into practical implementation activities in co-design with HCPs and implementation experts. In the end, each theme of the ISB consists of one to three multicomponent strategies. A complete description of the strategies in the ISB is presented per theme in additional file 3. Finally, the ISB was processed into a web-based implementation toolbox, which offers the ability to tailor strategies to HCPs\u0026rsquo; context per theme and facilitates HCPs chronologically during their implementation process.\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eProcedure\u003c/h3\u003e\n\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e\n \u003ch2\u003ePreparation phase\u003c/h2\u003e\n \u003cp\u003eAfter inclusion in the study, HCPs received an online ProMuscle training. During the training, HCPs were informed about the study and the preconditions to participate in the study (i.e. assigning a champion, arranging necessary materials, and approval of management to offer ProMuscle). Subsequently, to get insight into HCPs\u0026rsquo; context-specific barriers for implementation, HCPs completed an implementation readiness assessment based on the readiness tool of Wandersman (\u003cspan class=\"CitationRef\"\u003e22\u003c/span\u003e) and the Organizational Readiness assessment (ORIC) (\u003cspan class=\"CitationRef\"\u003e23\u003c/span\u003e). The implementation readiness assessment consisted of 32 statements about the seven domains described by the CFIR framework (i.e, patient needs (5 statements), internal context (14 statements), characteristics of professionals (3 statements), characteristics of the intervention (5 statements), implementation process (1 statement), and external context (4 statements)). The statements are scored on a 5-point Likert scale. Mean scores per domain were calculated. A mean score of lower than 3 for a domain was hypothesized as a domain of concern, meaning HCPs should mainly focus on that domain(s) during the implementation. The readiness assessment is presented in additional file 4. The results of the implementation readiness assessment were used to tailor the ISB to HCPs\u0026rsquo; individual contexts and needs during the implementation phase.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\n \u003ch2\u003eRandomization\u003c/h2\u003e\n \u003cp\u003eIncluded HCPs, each of them connected to an unique practice, were allocated to one of five clusters based on the geographical location of their practice. The reason for clustering HCPs on geographical location was to prevent contamination between HCPs working in the same community (\u003cspan class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e24\u003c/span\u003e). Because this study was conducted in a relatively small region, professionals from different practices were more likely to have mutual contact than when a study is conducted nationally. This increases the risk for contamination among practices. Besides, we wanted to prevent that a practice in one community benefits from the results of the ISB, for example, by improving their network and market value. Thus, clustering was on location of the practice a HCP worked in. Randomization took place at cluster level, i.e., the order in which the cluster transitioned to the intervention group. After all participants were allocated to a cluster, stratified randomization was conducted in an online tool to determine the time-point of transition to the intervention group during the implementation phase.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\n \u003ch2\u003eImplementation phase\u003c/h2\u003e\n \u003cp\u003eHCPs were instructed to start the implementation of ProMuscle as usual without receiving implementation support. The ISB was sequentially rolled out over the five clusters. During the transitional period of 6 weeks in which clusters transitioned to the intervention group, HCPs were informed about the ISB and received their personal ISB tailored to the results of the implementation readiness assessment assessed in the preparation phase. Transitions from control group to intervention group continued 6-weekly until all clusters received the ISB. An overview of the implementation study design and number of participating HCPs per cluster at each time point is presented in Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\n \u003ch2\u003eOutcomes\u003c/h2\u003e\n \u003cp\u003eImplementation outcomes and intervention outcomes were measured with online questionnaires. Additionally, demographics of participating HCPs and recipients of ProMuscle were collected.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\n \u003ch2\u003ePrimary outcomes\u003c/h2\u003e\n \u003cdiv id=\"Sec15\" class=\"Section3\"\u003e\n \u003ch2\u003eImplementation outcome\u003c/h2\u003e\n \u003cp\u003eThe primary implementation outcome of the study was the adoption of ProMuscle among HCPs. \u003cstrong\u003eAdoption\u003c/strong\u003e is defined as HCPs\u0026rsquo; intention to try or employ ProMuscle in their practice (\u003cspan class=\"CitationRef\"\u003e25\u003c/span\u003e). In line with Damschroder et al. (\u003cspan class=\"CitationRef\"\u003e26\u003c/span\u003e), we distinguished \u0026lsquo;adoptability\u0026rsquo; as anticipated implementation outcome prior to implementation and \u0026lsquo;adoption\u0026rsquo; as actual implementation outcome during and post-implementation. Adoptability was measured at baseline with the Measure of Innovation-Specific Implementation Intentions (MISII) (\u003cspan class=\"CitationRef\"\u003e27\u003c/span\u003e). The MISII is a three-item questionnaire that measures the intention to adopt an evidence-based intervention with a 5-point Likert scale. At the following time points, adoption was measured with the Provider REport of Sustainment Scale (PRESS) (\u003cspan class=\"CitationRef\"\u003e28\u003c/span\u003e). PRESS is a 3-item questionnaire that measures the continued use of an EBI on a 5-point Likert scale. For the MISII and PRESS a mean score of these items was calculated. There is no cut-off value known for the MISII and PRESS. Therefore, the research group decided that a mean score of three and higher was perceived as sufficient. The MISII and PRESS questionnaires are not yet available in Dutch and were therefore back- and forward-translated by an English native speaker.\u003c/p\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec16\" class=\"Section2\"\u003e\n \u003ch2\u003eSecondary outcomes\u003c/h2\u003e\n \u003cdiv id=\"Sec17\" class=\"Section3\"\u003e\n \u003ch2\u003eImplementation outcomes\u003c/h2\u003e\n \u003cp\u003eSecondary implementation outcomes were acceptability, feasibility, appropriateness, reach, and fidelity of ProMuscle measured on the HCPs level. \u003cstrong\u003eAcceptability\u003c/strong\u003e is the perception that the intervention is agreeable, pleasant, and satisfactory (\u003cspan class=\"CitationRef\"\u003e25\u003c/span\u003e). \u003cstrong\u003eFeasibility\u003c/strong\u003e is the extent to which an intervention can be used in a specific context (\u003cspan class=\"CitationRef\"\u003e25\u003c/span\u003e). \u003cstrong\u003eAppropriateness\u003c/strong\u003e is the perceived fit, relevance, or compatibility of ProMuscle (\u003cspan class=\"CitationRef\"\u003e25\u003c/span\u003e). The acceptability, feasibility, and appropriateness of ProMuscle were measured on two time points (T0, T6) using the Dutch translation of the Acceptability of Intervention Measure (AIM), Feasibility of Intervention Measure (FIM) and Intervention Appropriateness Measure (IAM) (\u003cspan class=\"CitationRef\"\u003e29\u003c/span\u003e). The AIM, FIM and IAM each consist of four statements that can be rated on a 5-point Likert scale: 1) completely disagree to 5) completely agree. The mean of the total score was calculated for each measure. The research group decided that a score of 3 and higher was perceived as acceptable, feasible, and appropriate. Earlier research of Weiner et al. showed that the questionnaires are valid and reliable measures (\u003cspan class=\"CitationRef\"\u003e29\u003c/span\u003e). \u003cstrong\u003eReach\u003c/strong\u003e was defined as the number of older adults who participated in ProMuscle (\u003cspan class=\"CitationRef\"\u003e25\u003c/span\u003e). Reach was measured at all time points by HCPs\u0026rsquo; self-report. The questionnaire contained two questions about the reach of ProMuscle: 1) \u0026ldquo;Did you deliver ProMuscle?\u0026rdquo; and 2) \u0026ldquo;How many older adults participated in ProMuscle?\u0026rdquo;. \u003cstrong\u003eFidelity\u003c/strong\u003e of ProMuscle is the degree to which an intervention was implemented as prescribed (\u003cspan class=\"CitationRef\"\u003e25\u003c/span\u003e). The number of activities described in the ProMuscle guideline were assessed with a self-report checklist based on this guideline.\u003c/p\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec18\" class=\"Section2\"\u003e\n \u003ch2\u003eIntervention outcomes\u003c/h2\u003e\n \u003cp\u003ePatient outcomes on physical functioning were collected from recipients of ProMuscle to gain insight into the effectiveness of ProMuscle when implemented. If present in the medical file, measurements before and after ProMuscle of physical function outcomes of older adults were used for analyses (\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e). Measurements assessing physical functioning were in line with previous ProMuscle effectiveness studies (\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e30\u003c/span\u003e) and included the repeated chair-rise test, Timed-Up-And-Go test (TUG), 1-repetition knee extension strength, and 1-Repetition Maximum (1RM) leg extension (\u003cspan class=\"CitationRef\"\u003e30\u003c/span\u003e).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec19\" class=\"Section2\"\u003e\n \u003ch2\u003eParticipant characteristics\u003c/h2\u003e\n \u003cp\u003eBaseline characteristics of the participating HCPs were collected using a questionnaire, including age (years), occupation (physical therapist/dietician), and gender (male/female/unknown). Characteristics of ProMuscle recipients (i.e. age, gender, length, education, living situation) were collected from the medical file.\u003c/p\u003e\n \u003cp\u003eAn overview of the assessed implementation outcomes, intervention outcomes, and participant demographics including the level of assessment, the corresponding measurements, and timing is presented in Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\n \u003cdiv class=\"gridtable\"\u003e\n \u003ctable id=\"Tab1\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eOverview of outcome measurement per time point\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\" colspan=\"11\"\u003e\n \u003cp\u003eTiming of measurements\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\" colspan=\"9\"\u003e\n \u003cp\u003eHCP\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003eRecipients\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eOutcome\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eT0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eTP\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eT1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eT2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eT3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eT4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eT5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eT6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eT7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 wks\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e12 wks\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCharacteristics of HCPs\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eQuestionnaire\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCharacteristics of recipients\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eMeasurement HCP\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAdoption\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eQuestionnaire\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex*\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAcceptability ProMuscle\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eQuestionnaire\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAppropriateness ProMuscle\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eQuestionnaire\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eFeasibility ProMuscle\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eQuestionnaire\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eReach ProMuscle\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eQuestionnaire\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eFidelity ProMuscle\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eQuestionnaire\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eImplementation readiness\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eQuestionnaire\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eIn\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePhysical functioning older adults\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eMeasurement HCP\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003ctfoot\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"13\"\u003e\u003cem\u003eNote: * = adoptability measured at T0 (MISII) instead of adoption (PRESS); D\u0026thinsp;=\u0026thinsp;demographics; I\u0026thinsp;=\u0026thinsp;implementation outcome; In =\u0026thinsp;intervention outcome; TP\u0026thinsp;=\u003c/em\u003e\u0026thinsp;Transitional period\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tfoot\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec20\" class=\"Section2\"\u003e\n \u003ch2\u003eSample size\u003c/h2\u003e\n \u003cp\u003eThe primary outcome for this study, the adoption of ProMuscle, was measured with the PRESS questionnaire (\u003cspan class=\"CitationRef\"\u003e28\u003c/span\u003e). As there is little empirical data available to provide an estimate of the intervention\u0026rsquo; effect on the primary outcome, an assumed effect size of 0.5 with a standard deviation of 1 was used. Sample size estimation was performed with the Shiny CRT app (\u003cspan class=\"CitationRef\"\u003e31\u003c/span\u003e), with a significance level of 0.05 and power set at 0.80.\u003c/p\u003e\n \u003cp\u003eWe aimed for five sequences with one cluster per sequence receiving the intervention, resulting in a cluster size of 5 HCPs, representing 5 unique practices. Taking into account a drop-out of 20% during the study (\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e), a minimum sample size of 30 HCPs, divided over 5 clusters was considered.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec21\" class=\"Section2\"\u003e\n \u003ch2\u003eStatistical analysis\u003c/h2\u003e\n \u003cp\u003eDifferences between clusters at baseline were analyzed with the Kruskall-Wallis test (degrees of freedom\u0026thinsp;=\u0026thinsp;4) for continuous variables and the chi-square test for categorical variables to gain insight into possible differences between regions (i.e. clusters). Continuous variables were presented as mean and standard deviation (SD) or mean and standard error (SE). Categorical variables were presented as numbers (N) and percentages (%). Lastly, baseline characteristics of participating HCPs and recipients of ProMuscle were presented as descriptive statistics.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec22\" class=\"Section2\"\u003e\n \u003ch2\u003ePrimary outcome\u003c/h2\u003e\n \u003cp\u003eAdoption of ProMuscle was analyzed with linear mixed model. A random intercept per cluster (to account for clustering of HCPs) and per subject (to account for time effects) was included. The effect of the intervention and differences over time were included in all models. In an additional step, gender and occupation were included as potential correction factors. Validity of the models, i.e. normality and homoscedasticity, was assessed by examining residuals. Differences within clusters over time were analyzed with linear mixed model, corrected for time, gender, and occupation with an interaction for cluster*timepoint.\u003c/p\u003e\n \u003cdiv id=\"Sec23\" class=\"Section3\"\u003e\n \u003ch2\u003eSecondary outcomes\u003c/h2\u003e\n \u003cp\u003eThe implementation outcomes, acceptability, feasibility, and appropriateness of ProMuscle (measured at T0 and T6) were analyzed with linear mixed model. Correction for time and intervention effects was included to account for clustering and repeated measurements.\u003c/p\u003e\n \u003cp\u003eReach and fidelity of ProMuscle were compared between the control and the intervention group with generalized linear mixed model for binomial distributions for dichotomous outcomes and linear mixed model for continuous outcomes on reach. Both models accounted for clustering, similar to the analysis of the primary outcome.\u003c/p\u003e\n \u003cp\u003ePhysical functioning measurements of recipients before and after ProMuscle (0 weeks and 12 weeks) were assessed and presented as descriptive statistics.\u003c/p\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec24\" class=\"Section2\"\u003e\n \u003ch2\u003eSensitivity analysis\u003c/h2\u003e\n \u003cp\u003eA sensitivity analysis was conducted to assess the impact of missing data on the primary outcome. Multiple imputation by chained equations was applied with all variables from the analyses and included corrections for clustering as described for the analyses of the primary outcome.\u003c/p\u003e\n \u003cp\u003eSignificance level was set at p\u0026thinsp;\u0026lt;\u0026thinsp;0.05. Analyses were conducted using SAS V9.4 for Windows (SAS Institute Inc., Cary, NC, USA) and SPSS version 29 (SPSS IMB Corp., USA). Multiple imputation was performed with the MICE, miceadds and pan packages in R (v4.4.2).\u003c/p\u003e\n\u003c/div\u003e"},{"header":"RESULTS","content":"\u003cdiv id=\"Sec26\" class=\"Section2\"\u003e\u003ch2\u003eParticipants\u003c/h2\u003e\u003cp\u003eOf the HCPs that responded to the invitation to participate, 35 were eligible to participate in this study. Nine HCPs eventually dropped out before the start of the study, resulting in a total of 26 HCPs that started the implementation study at T0. In the control period, one HCP entered and two dropped out, so 25 HCPs received the ISB during the transitional period. During the intervention period, two HCPs entered the study and two dropped out. In total 29 HCPs participated in this study, of whom 23 participated completely and six partly. Figure\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e presents the number of participants per cluster and time point.\u003c/p\u003e\u003cp\u003eMost of the participants were female (76%) and more physical therapists (62%) than dieticians participated. Baseline measurements on implementation outcomes showed relatively high scores on adoptability, acceptability, and feasibility of ProMuscle. Besides gender, there were no significant differences between clusters. All participants scored higher than 96 (i.e. low readiness) on the implementation readiness assessment. The characteristics of the participants per cluster are described in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eCharacteristics of the participants (n\u0026thinsp;=\u0026thinsp;26) at baseline. Presented as N (%) or Mean (standard deviation)\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"8\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eCluster 1 (N\u0026thinsp;=\u0026thinsp;5)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eCluster 2 (N\u0026thinsp;=\u0026thinsp;6)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eCluster 3 (N\u0026thinsp;=\u0026thinsp;5)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eCluster 4 (N\u0026thinsp;=\u0026thinsp;5)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eCluster 5 (N\u0026thinsp;=\u0026thinsp;5)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c7\"\u003e\u003cp\u003eTotal (N\u0026thinsp;=\u0026thinsp;26) (%), Mean(SD)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c8\"\u003e\u003cp\u003eP\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colspan=\"8\" nameend=\"c8\" namest=\"c1\"\u003e\u003cp\u003eDescriptive characteristics\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOccupation (physical therapist)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4 (57.14)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4 (66.67)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e3 (60)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e4 (66.67)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e3 (60)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e18 (62)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.995\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge (years)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e37.8 (SD:15.75)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e48.60 (SD:11.92)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e33.60 (SD:6.66)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e41.00 (SD:16.27)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e42.40 (SD:10.28)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e40.62 (SD:12.47)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.31\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGender\u003c/p\u003e\u003cp\u003e(female)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2 (28.57)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e6 (100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e5 (100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e4 (66.67)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e5 (100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e22 (76)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.01*\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"8\" nameend=\"c8\" namest=\"c1\"\u003e\u003cp\u003e\u003cb\u003eImplementation outcomes\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAdoptability\u003c/p\u003e\u003cp\u003e(range 1\u0026ndash;5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3.4\u003c/p\u003e\u003cp\u003e(SD:0.93)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e3.8\u003c/p\u003e\u003cp\u003e(SD:0.87)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e3.73 (SD:0.72)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e3.08 (SD:0.32)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e3.4\u003c/p\u003e\u003cp\u003e(SD:0.64)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e3.5\u003c/p\u003e\u003cp\u003e(SD: 0.72)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.62\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eReadiness\u003c/p\u003e\u003cp\u003e(max score 160)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e136.00 (SD:10.20)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e132.80 (SD:13.61)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e133.40 (SD:11.68)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e115.25 (SD:12.97)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e130.00 (SD:14.27)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e130.08 (SD:13.46)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.24\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAcceptability\u003c/p\u003e\u003cp\u003e(range 1\u0026ndash;5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4.45 (SD:0.57)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4.45 (SD:0.62)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e4.25 (SD:0.47)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e4.19 (SD:0.658)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e4.25 (SD:0.56)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e4.32\u003c/p\u003e\u003cp\u003e(SD: 0.53)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.90\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFeasibility\u003c/p\u003e\u003cp\u003e(range 1\u0026ndash;5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3.65 (SD:0.42)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e3.75 (SD:0.94)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e3.4\u003c/p\u003e\u003cp\u003e(SD:0.45)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e3.56 (SD:0.83)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e4.0\u003c/p\u003e\u003cp\u003e(SD:0.64)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e3.68\u003c/p\u003e\u003cp\u003e(SD: 0.65\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.69\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAppropriateness (range 1\u0026ndash;5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4.15 (SD:0.55)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4.20 (SD:0.72)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e3.95 (SD:0.21)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e3.56 (SD:0.38)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e4.15 (SD:0.49)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e4.02\u003c/p\u003e\u003cp\u003e(SD: 0.50\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e0.34\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"8\"\u003e*= significant difference P\u0026thinsp;\u0026lt;\u0026thinsp;0.05\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eThere was 30% missing data for the primary outcome adoption; missing data occurred mostly at later moments during the study. For two HCPs data was missing completely and were therefore excluded from the analysis, resulting in analysis for 27 HCPs with a total of 142 measurements over time for the primary outcome.\u003c/p\u003e\u003cdiv id=\"Sec27\" class=\"Section3\"\u003e\u003ch2\u003ePrimary outcome\u003c/h2\u003e\u003cdiv id=\"Sec28\" class=\"Section4\"\u003e\u003ch2\u003eAdoption of ProMuscle\u003c/h2\u003e\u003cp\u003eWith a total mean of 3.5 (SD: 0.72), the adoptability among participants was sufficient.\u003c/p\u003e\u003cp\u003eOverall, the intervention group showed a statistically non-significant increase of adoption with a mean difference of 0.32 (95% CI: -0.18\u0026ndash;0.81; p\u0026thinsp;=\u0026thinsp;0.21) compared with the control group after correction for potential confounders. However, differences in adoption between clusters varied and fluctuated over time, as presented in Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. Cluster 1 increased their mean adoption from 1.14 (SE: 0.43) at T1 to 2.70 (SE: 0.54) at T7. The mean adoption of cluster 3 decreased from 2.04 (SE: 2.04) at baseline (T1) to 1.9 (SE: 0.40) at T7. Cluster 5 was the only cluster with an adoption score higher than 3 at T7 (3.06 SE: 0.45), other clusters\u0026rsquo; mean scores on adoption varied between 1.80 and 2.84 at T7. Intracluster correlation without correction for confounders was 0.27.\u003c/p\u003e\u003cdiv id=\"Sec29\" class=\"Section2\"\u003e\u003ch2\u003eSecondary outcomes\u003c/h2\u003e\u003cdiv id=\"Sec30\" class=\"Section3\"\u003e\u003ch2\u003eAcceptability, feasibility, and appropriateness of ProMuscle\u003c/h2\u003e\u003cp\u003eAcceptability of ProMuscle scored a mean of 4.33 (SE:0.14) at baseline. At the end of the study, the acceptability scores remained above 3 in every cluster, indicating that ProMuscle was still considered acceptable. Acceptability significantly decreased over time, with a mean difference of -0.30 (95% CI: -0.59 \u0026ndash; -0.01; p\u0026thinsp;=\u0026thinsp;0.04). Feasibility and appropriateness scored 3.7 (SE: 0.18) and 4.0 (SE: 0.16), respectively, at baseline. A significant decrease in both feasibility and appropriateness was observed in the intervention group compared with the control group, with a mean difference of -0.62 (95% CI 0.14\u0026ndash;1.08; p\u0026thinsp;=\u0026thinsp;0.01) for feasibility and \u0026minus;\u0026thinsp;0.68 (95% CI 0.30\u0026ndash;1.06; p\u0026thinsp;\u0026lt;\u0026thinsp;0.001) for appropriateness.\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv id=\"Sec31\" class=\"Section2\"\u003e\u003ch2\u003eReach and fidelity of ProMuscle\u003c/h2\u003e\u003cp\u003eReach and fidelity of ProMuscle are presented as descriptives as these outcomes could not be analyzed because of the low number of older adults participating in ProMuscle and HCPs that delivered ProMuscle. Concerning reach, in the intervention group, more HCPs delivered ProMuscle (51%) compared to the control group (34%). Due to unclear data concerning the reach, it was not possible to determine the exact number of older adults participating in ProMuscle. For example, HCPs answered the question \u0026ldquo;Did you deliver ProMuscle?\u0026rdquo; with yes but did not provide how many older adults participated in ProMuscle.\u003c/p\u003e\u003cp\u003eDescriptives did show a higher fidelity of ProMuscle (100%) in the intervention group for physical therapists and dieticians compared to the control group (56% for the physical therapists, 50% for dieticians).\u003c/p\u003e\u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e presents the mean change scores on secondary implementation outcomes (acceptability, feasibility, and appropriateness) between the control and intervention group as well as the descriptive data on reach and fidelity of ProMuscle.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eResults of the mixed model analysis on acceptability, feasibility, and appropriateness presented as mean (standard error), and the results of reach and fidelity presented as N(%) between control and intervention group\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"6\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\"\u0026minus;\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOutcome\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eTime-point\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eControl\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eIntervention\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eMean difference (95% CI)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eP\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAcceptability\u003c/p\u003e\u003cp\u003e(range 1\u0026ndash;5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eT0, T6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4.33 (SE: 0.14)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e4.03 (SE: 0.14)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026minus;\" colname=\"c5\"\u003e\u003cp\u003e-0.30 (-0.58 - -0.02)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.04*\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFeasibility\u003c/p\u003e\u003cp\u003e(range 1\u0026ndash;5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eT0, T6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e3.69 (SE: 0.18)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e3.08 (SE: 0.20)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.62 (0.14\u0026ndash;1.08)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.01*\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAppropriateness\u003c/p\u003e\u003cp\u003e(range 1\u0026ndash;5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eT0, T6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4.03 (SE: 0.15)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e3.35 (SE: 0.16)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.68 (0.30\u0026ndash;1.06)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.001*\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eReach (yes)\u003c/p\u003e\u003cp\u003eN (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eT1-T7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e16 (\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e27 (\u003cspan citationid=\"CR51\" class=\"CitationRef\"\u003e51\u003c/span\u003e)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFidelity\u003c/p\u003e\u003cp\u003eN(%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eT1-T7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePT Intake (yes)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e5 (56)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e12 (100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePT Frequency training (yes)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e5 (56)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e12 (100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePT intensify training (yes)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e5 (56)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e12 (100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePT Grouptraining (yes)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e5 (56)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e12 (100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePT use of fitness equipment (yes)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e5 (83)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e12 (100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDT Frequency yes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e2 (\u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e9 (100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"6\"\u003e*= significant difference between control and intervention group analyzed by Linear Mixed Model corrected for time; PT\u0026thinsp;=\u0026thinsp;physical therapist; DT\u0026thinsp;=\u0026thinsp;dietician\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec32\" class=\"Section2\"\u003e\u003ch2\u003eSensitivity analysis\u003c/h2\u003e\u003cp\u003eSensitivity analysis was conducted to check if the results would be different when the data were complete. Multiple imputation was used to impute missing data. Due to the low number of participating older adults in ProMuscle, multiple imputation was not possible for missing data on fidelity and reach of ProMuscle. Results showed that there were no significant differences in adoption scores of ProMuscle when data were imputed (mean difference 0.31, 95% CI:-0.43-1.06; p\u0026thinsp;=\u0026thinsp;0.41). For acceptability and feasibility of ProMuscle, the significant difference between T0 and T6 disappeared. The mean differences were \u0026minus;\u0026thinsp;0.28 (95% CI: -0.62-0.07; p\u0026thinsp;=\u0026thinsp;0.11) for acceptability and \u0026minus;\u0026thinsp;0.45 (95% CI: -1.05-0.16; p\u0026thinsp;=\u0026thinsp;0.13) for feasibility.\u003c/p\u003e\u003cdiv id=\"Sec33\" class=\"Section3\"\u003e\u003ch2\u003ePhysical Functioning of Recipients\u003c/h2\u003e\u003cp\u003ePatient outcomes (n\u0026thinsp;=\u0026thinsp;21) are presented as descriptive statistics in Table \u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e. Older adults who participated in ProMuscle had a mean age of 72 years, the majority did not receive care (90%), and lived independently with their partner or children (81%). Visual interpretation of physical functioning outcomes shows an improvement on all measurements before and after participation in ProMuscle.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003ePatient outcomes of older adults participated in ProMuscle. Presented as mean (SD) or N (%).\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"3\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePatient outcomes (N\u0026thinsp;=\u0026thinsp;21)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e\u003cp\u003e\u003cb\u003ePatient characteristics\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eT0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e72.1 (SD: 6.56)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGender (male)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e13 (61.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eType of care\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNone\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e19 (90.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePartner\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2 (9.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHome situation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAlone\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4 (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTogether\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e17 (81)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEducation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLow\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1 (4.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eIntermediate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e7 (33.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHigh\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3 (14.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLength (cm)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e169.44 (SD: 13.58)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"3\" nameend=\"c3\" namest=\"c1\"\u003e\u003cp\u003e\u003cb\u003ePhysical functioning outcomes\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eT0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eT2 (12 weeks)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e5 times sit to stand (sec)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e10.25 (SD: 3.06)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e8.36 (SD: 1.19)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTUG (sec)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e8.8 (SD: 3.54)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e7.21 (SD: 2.92)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e1RM Legpress (kg)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e140.26 (SD: 58.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e172.46 (SD: 82.95)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e1RM Leg extension (kg)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e47.15 (SD: 17.69)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e71.17 (SD: 33.27)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eWeight (kg)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e77.54 (SD: 14.61)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e78.56 (SD: 14.99)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThis hybrid type III stepped-wedge randomized cluster implementation-effectiveness trial aimed to evaluate the impact of the Implementation Strategy Bundle (ISB) on the adoption of ProMuscle, a lifestyle intervention for community-dwelling older adults. Results showed an increase in adoption in the intervention group compared to the control group. However, this increase was not statistically significant.\u003c/p\u003e\u003cp\u003eTo our knowledge, this is the first trial to investigate the effect of an ISB on the adoption of a lifestyle intervention for community-dwelling older adults among physical therapists and dieticians in multiple community care settings.\u003c/p\u003e\u003cp\u003eAlthough an increase in adoption of ProMuscle by individual HCPs was observed over time, scores fluctuated, and no significant differences were found between groups. Most increases in adoption occurred directly after HCPs received the ISB and simultaneously with increasing reach rates. This may indicate a modest effect of the ISB on adoption and/or a relationship between adoption and reach of ProMuscle. Additionally, it is known that higher strategy fidelity tends to yield better clinical outcomes (\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e). In the current study, we were unable to assess the relationship between the ISB usage and the implementation outcomes adoption and reach of ProMuscle due to the limited number of participating recipients. However, a process evaluation conducted alongside this trial explored the use of the ISB in more depth. It can be suggested that the non-significant effect on adoption was due to inadequate use of the ISB, rather than its ineffectiveness (\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e). Further research should assess the relationship between adoption, reach, and ISB usage.\u003c/p\u003e\u003cp\u003eThe timing of ISB delivery could also have influenced the results. Timing is a known challenge in stepped wedge trials, where participants receive the intervention at fixed time points (\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e). In this study, some HCPs received the ISB as late as 36 weeks after baseline, and the number of missing data increased over time. However, analyses were corrected for timing, and the results remained unchanged following multiple imputation of the missing data.\u003c/p\u003e\u003cp\u003eAdditionally, characteristics of HCPs are a known contributor to the implementation of EBIs (\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e). At baseline, all HCPs scored relatively high on adoptability, indicating a high motivation to implement ProMuscle. According to the Diffusion of Innovation theory, five different categories of people can be characterized that adopt an innovation based on their willingness and adoption speed: innovators, early adopters, early majority, late majority, and laggards (\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e). Innovators are typically proactive, have an extensive network, have financial resources and knowledge, can handle uncertainties about an intervention, and are mostly the first to implement new ideas. Reflecting on the results of this study, participants could be characterized following the theory of Rogers. Three clusters showed relatively high adoptability and adoption scores at baseline (T0 and T1). Over time, the adoption of one cluster declined (cluster 3), while the other two clusters increased their adoption and reach. It can be suggested that characteristics played a role in the implementation, as the HCPs in these two clusters were mainly older, had more work experience, and were probably innovators with experience in implementing innovations. For this group the ISB could be sufficient, as innovators are most likely familiar with the actions needed for implementation and are aware of potential barriers that could influence the implementation. In contrast, HCPs with less experience in implementation (e.g. early majority, late majority, and laggards) may need more personalized support to increase the adoption of ProMuscle (\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eThe long-term goal of the PUMP-fit implementation study is to sustain the implementation support when the researchers withdraw from the implementation study. To achieve this, HCPs must remain motivated to implement ProMuscle. In a previous process evaluation, HCPs evaluated the lifestyle intervention ProMuscle as valuable and acceptable (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). Similarly, the relatively high baseline scores in this study suggest that HCPs believed ProMuscle fits their practice and current demand for care. Remarkably, except for one cluster (cluster 5), this study showed a significant decrease in acceptability, feasibility, and appropriateness of ProMuscle over time. Despite this decline, scores remained above the moderate threshold of 3. However, the decrease in acceptability warrants further exploration. One possible explanation could be the timing within this trial\u0026rsquo; design. As mentioned earlier, Caille et al. (\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e) described that the effect of an intervention can change over time in stepped wedge trials. In our analysis we corrected for time to account for possible interaction with the intervention\u0026rsquo;s effect. Moreover, we assessed if the effect of the ISB varied over time. Although no significant interaction was found, the results of this analysis should be interpreted with caution due to limited sample size and statistical power.\u003c/p\u003e\u003cp\u003eAnother possible explanation for the decrease in acceptability is that the motivation of HCPs dropped during the study, particularly when the implementation was not as successful as expected. High acceptability among HCPs is likely associated with successful implementation of ProMuscle. This is supported by the results of this study and the process evaluation of van Dongen et al (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). Therefore, it is important to ensure engagement and motivation of HCPs throughout the implementation and sustainment. Support by way of an online-provided ISB may not be sufficient, some HCPs may require active encouragement. For example, education is a known and widely used implementation strategy for changing behavior and increasing motivation and knowledge (\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e). Further exploration of drivers and possibilities to increase the impact of the ISB could be assessed in a process evaluation.\u003c/p\u003e\u003cp\u003eSimilar implementation trials (\u003cspan additionalcitationids=\"CR40 CR41\" citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e) that \u0026ldquo;failed\u0026rdquo; to show effects or showed mixed effects of a strategy bundle on implementation suggest that contextual factors may have influenced the effect of the strategy bundle (\u003cspan additionalcitationids=\"CR44 CR45\" citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e). As highlighted by multiple authors (\u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e, \u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e), the complex process of implementation involves a various range of actors across multiple system levels. Particularly, when aiming for sustainment and scale-up, different factors on different levels (i.e. inner setting, process, intervention characteristics, and outer setting) need to be considered (\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e). In the case of ProMuscle, implemented across multiple care settings, contextual factors at organizational and policy-level, such as external leadership, funding environment, values, needs, and priorities of stakeholders (\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e) could have influenced the impact of the ISB on the adoption of ProMuscle.\u003c/p\u003e\u003cp\u003eThese outer-setting contextual factors were not extensively addressed by the ISB. First, these factors were not identified by literature and HCPs during the development of the ISB. Secondly, this study focused on a small-scale implementation, whereas such contextual factors are more commonly addressed in scale-up studies. Moreover, addressing contextual factors on organizational or policy-level could be challenging for individual HCPs. This highlights the need for future studies to consider the possible effect of outer-setting contextual factors, even for smaller-scale implementation initiatives and earlier implementation phases (\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e, \u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e, \u003cspan citationid=\"CR51\" class=\"CitationRef\"\u003e51\u003c/span\u003e). Additionally, the complexity of implementation shows a need for models and frameworks to identify factors for the success of the implementation (\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e, \u003cspan citationid=\"CR52\" class=\"CitationRef\"\u003e52\u003c/span\u003e), the process, and the working mechanism of a strategy or multiple strategies. Understanding why the ISB was not successful and how it could be successful in implementing a lifestyle EBI like ProMuscle(\u003cspan citationid=\"CR53\" class=\"CitationRef\"\u003e53\u003c/span\u003e) is essential for successful scale-up of ProMuscle and generalization of results to other contexts (Geng).\u003c/p\u003e\n\u003ch3\u003eMethodological considerations\u003c/h3\u003e\n\u003cp\u003eSome methodological considerations should be made. A strength of this study is the use of a stepped-wedge design to assess the impact of the ISB on the adoption of ProMuscle. This design is particularly suitable in small sample size studies and regional contexts (\u003cspan additionalcitationids=\"CR19\" citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). The design prevents contamination between HCPs working in the same community (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e). Moreover, the ISB was accessible to all HCPs in the Foodvalley, supporting equitable implementation support.\u003c/p\u003e\u003cp\u003eSome limitations could be mentioned. First, missing data increased over time, with 30% of data missing at the end of the study. Sensitivity analysis using multiple imputations was conducted to account for the missing data. Results did not show a difference in the results of the original data, indicating that the missing data did not bias the results. Second, the sample size in our study was relatively small. Approximately 16% of the invited HCPs participated (n\u0026thinsp;=\u0026thinsp;30) in this study. This response rate aligns with other studies (\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e) and we reached the predetermined minimal sample size of 25 HCPs. However, a larger sample could have increased statistical power, improved corrections for time and variability of context, and may have enhanced the ability to detect a significant effect of the ISB on adoption. Moreover, a larger sample size could also improve the generalization of results to other contexts or lifestyle interventions. Third, because of the low reach of ProMuscle, we were unable to analyze fidelity and intervention outcomes on physical functioning. However, in prior work, Dorhout et al. showed that ProMuscle remains effective in improving physical functioning and muscle strength in implementation settings (\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eLastly, the PRESS may not have been the ideal measurement to measure adoption among HCPs. Although adoption increased over time, the change was insufficient to detect significant differences between groups. The trials\u0026rsquo; protocol hypothesized an effect size of 0.5. While most clusters in this study showed an increase of more than 0.5, the overall mean change was 0.3. This raises questions about the cut-off value and the potential presence of a ceiling effect. Moreover, some HCPs reported high adoption scores despite having zero reach, suggesting a disconnect between intention and actual implementation. While the definition of adoption in this study was based on intention to use ProMuscle (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e), this discrepancy highlights the need for consensus on implementation outcome definitions and the development of more valid tools to capture adoption in real-world settings.\u003c/p\u003e\n\u003ch3\u003eImplications\u003c/h3\u003e\n\u003cp\u003eOverall, these findings highlight the complexity of implementing evidence-based interventions in real-world settings and emphasize the need for adaptable, context-aware strategies (\u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e). Current implementation taxonomies do not fully account for the complexity of implementation and the multiple system-level factors and contexts (\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e). The results of this study suggest that individual characteristics may affect the adoption of a lifestyle intervention in multiple community care settings. Moreover, based on earlier research on sustainment and upscaling, EBIs\u0026rsquo; contextual factors on organizational and policy-level could have contributed to the ISB\u0026rsquo; impact on adoption. Given the complexity and variety of factors influencing the implementation, it seems necessary to employ multi-faceted or strategy bundles like we used in the current study. It also raises the question if real-world implementation may outweigh the theoretical need to assess individual strategy effectiveness (\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e). There is a need for further understanding of how strategies can be tailored to specific contexts, which (combination of) strategies could be effective in real-world implementation of EBIs, and how strategies should be deployed (\u003cspan citationid=\"CR52\" class=\"CitationRef\"\u003e52\u003c/span\u003e).\u003c/p\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eThis stepped wedge cluster trial did not demonstrate a statistically significant effect of an Implementation Strategy Bundle on the adoption of the evidence-based lifestyle intervention ProMuscle for community-dwelling older adults among HCPs. Moreover, the results revealed a significant decline in acceptability of ProMuscle and low reach rates over time. The results of this study highlight the complexity of implementing lifestyle EBIs across multiple community care settings. It shows that the effectiveness of implementation support can depend on the needs and skills of HCPs. Moreover, contextual factors likely influenced the implementation and the ISB\u0026rsquo;s effect on adoption. Further exploration is warranted to determine whether and how contextual factors influenced the implementation and moderated the impact of the ISB on the adoption of ProMuscle. Gaining insights into the complex dynamics of implementation is essential for informing strategies to enhance real-world adoption, sustainment, and scale-up of EBIs in community-care settings.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eISB = Implementation Strategy Bundle\u003c/p\u003e\n\u003cp\u003eHCP = HealthCare Professional\u003c/p\u003e\n\u003cp\u003eEBI = Evidence Based Intervention\u0026nbsp;\u003c/p\u003e"},{"header":"Declarations","content":"\u003cul type=\"disc\"\u003e\n \u003cli\u003eEthics approval and consent to participate: All participants gave written consent for participation in this trial. The Medical Ethical Committee of the University Medical Center Utrecht approved this study (22/050)\u003c/li\u003e\n \u003cli\u003eConsent for publication: not applicable\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eAvailability of data and materials: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.\u003c/li\u003e\n \u003cli\u003eCompeting interests:\u0026nbsp;The authors declare that they have no competing interests.\u003c/li\u003e\n \u003cli\u003eFunding:\u0026nbsp;The research described in this paper was financially supported by a grant from the Regiodeal Foodvalley (162135)\u003c/li\u003e\n \u003cli\u003eAuthors\u0026apos; contributions: B.D and PL set up the study under supervision of DB. P.L. was the contact person for the participating professionals. P.L., collected and analyzed data from surveys. P.Z. and P.L. conducted the LMM analyses and MI of the primary outcomes. P.L. wrote the manuscript. B.D., D.B., C.V., L.S., P.Z. provided feedback and input for the analysis of the data, critically read, and provided feedback for the manuscript. All authors have read and approved the manuscript for submission.\u003c/li\u003e\n \u003cli\u003eAcknowledgements: not applicable\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eWHO Regional Office for Europe. Promoting physical activity and healthy diets for healthy ageing in the WHO European Region [Internet]. Copenhagen; 2023 [cited 2025 Mar 14]. 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BMJ (Online). 2018;363.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAkiba CF, Powell BJ, Pence BW, Muessig K, Golin CE, Go V. \u0026ldquo;We start where we are\u0026rdquo;: a qualitative study of barriers and pragmatic solutions to the assessment and reporting of implementation strategy fidelity. Implement Sci Commun. 2022;3(1).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAshcraft LE, Goodrich DE, Hero J, Phares A, Bachrach RL, Quinn DA, et al. A systematic review of experimentally tested implementation strategies across health and human service settings: evidence from 2010\u0026ndash;2022. Vol. 19, Implementation Science. BioMed Central Ltd; 2024.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCaille A, Billot L, Kasza J. Practical and methodological challenges when conducting a cluster randomized trial: Examples and recommendations. ournal of Epidemiology and Population Health. 2024;72(202199).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eRogers EM. Diffusion of innovations. Free Press; 1995. 519 p.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBrockman A, Krupp A, Bach C, Mu J, Vasilevskis EE, Tan A, et al. Clinicians\u0026rsquo; Perceptions on Implementation Strategies Used to Facilitate ABCDEF Bundle Adoption: A Multicenter Survey. 2023.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eVis C, Schuurmans J, Aouizerate B, Atipei Craggs M, Batterham P, B\u0026uuml;hrmann L, et al. Effectiveness of Self-guided Tailored Implementation Strategies in Integrating and Embedding Internet-Based Cognitive Behavioral Therapy in Routine Mental Health Care: Results of a Multicenter Stepped-Wedge Cluster Randomized Trial. J Med Internet Res. 2023;25:e41532.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSpoelstra SL, Schueller M, Basso V, Sikorskii A. Results of a multi-site pragmatic hybrid type 3 cluster randomized trial comparing level of facilitation while implementing an intervention in community-dwelling disabled and older adults in a Medicaid waiver. Implementation Science. 2022;17(1).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLiddy C, Hogg W, Singh J, Taljaard M, Russell G, Deri Armstrong C, et al. A real-world stepped wedge cluster randomized trial of practice facilitation to improve cardiovascular care. Implementation Science. 2015;10(1).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eWiggers J, McElwaine K, Freund M, Campbell L, Bowman J, Wye P, et al. Increasing the provision of preventive care by community healthcare services: A stepped wedge implementation trial. 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BioMed Central Ltd; 2024.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eZurynski Y, Ludlow K, Testa L, Augustsson H, Herkes-Deane J, Hutchinson K, et al. Built to last? Barriers and facilitators of healthcare program sustainability: a systematic integrative review. Vol. 18, Implementation Science. BioMed Central Ltd; 2023.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHarvey G, Kitson A. Translating evidence into healthcare policy and practice: Single versus multi-faceted implementation strategies - Is there a simple answer to a complex question? Vol. 4, International Journal of Health Policy and Management. Kerman University of Medical Sciences; 2015. p. 123\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMiller CJ, Barnett ML, Baumann AA, Gutner CA, Wiltsey-Stirman S. The FRAME-IS: a framework for documenting modifications to implementation strategies in healthcare. Implementation Science. 2021;16(1).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003ePowell BJ, Fernandez ME, Williams NJ, Aarons GA, Beidas RS, Lewis CC, et al. Enhancing the impact of implementation strategies in healthcare: A research agenda. Front Public Health. 2019;7(JAN).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSpoon D, de Leg\u0026eacute; T, Oudshoorn C, van Dijk M, Ista E. Implementation strategies of fall prevention interventions in hospitals: a systematic review. BMJ Open Qual. 2024;13(4).\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"implementation-science-communications","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"iscm","sideBox":"Learn more about [Implementation Science Communications](https://implementationsciencecomms.biomedcentral.com)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/ISCM/default.aspx","title":"Implementation Science Communications","twitterHandle":"@ImplementSci","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Implementation, stepped wedge cluster trial, hybrid type III, Implementation Strategy Bundle, lifestyle intervention, community care settings, older adults, healthcare professionals","lastPublishedDoi":"10.21203/rs.3.rs-8057231/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8057231/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: ProMuscle is an evidence-based combined lifestyle intervention to promote physical functioning in community-dwelling older adults. To address identified barriers for the implementation of ProMuscle in community care settings, a theory and practice-based Implementation Strategy Bundle (ISB) was developed. The current study aims\u003c/p\u003e\n\u003cp\u003eto investigate the impact of this ISB on the adoption of ProMuscle in multiple community care settings.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: A 42-week hybrid type III stepped-wedge randomized cluster implementation- effectiveness trial was conducted in Dutch community care. Participating healthcare professionals (i.e. physical therapists and dieticians) were allocated to one of five clusters based on their geographical location. The ISB targets multiple barriers (knowledge, costs, internal and external network) with multicomponent implementation strategies tailored to participants’ contexts using an online tool. Participants were trained to deliver ProMuscle and started the implementation as usual (i.e. without implementation support). Every six weeks one cluster transitioned to the intervention group. During this transitional period, participants gained access to the ISB. The primary outcome, adoption of ProMuscle, was measured on eight consecutive time points with the Provider REport of Sustainment Scale (PRESS). Adoption was analyzed with linear mixed models with random cluster effects and fixed time effects, corrected for gender and occupation. Secondly, reach, fidelity, acceptability, and feasibility of ProMuscle were evaluated over time as well as physical functioning outcomes of participating older adults.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e: Thirty healthcare professionals participated, data of 27 could be included for analysis. The intervention group showed a statistically non-significant increase of adoption of 0.32 (95% CI: -0.18-0.81; p=0.21) compared with the control group. After 42 weeks, 51% of the healthcare professionals had delivered ProMuscle, and fidelity of ProMuscle was higher in the intervention group than in the control group. Acceptability of ProMuscle significantly declined over time.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion: \u003c/strong\u003eThe findings highlight the complexity of implementing combined lifestyle interventions such as ProMuscle in multiple community care settings. No significant effect of the ISB on the adoption was found. The results of this study suggest contextual factors likely influenced the implementation. Further exploration is needed into whether contextual factors moderated the impact of the ISB on the adoption of ProMuscle.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration: \u003c/strong\u003eClinicalTrials.gov (NCT05672004) registered at 12/07/2022.\u003c/p\u003e","manuscriptTitle":"The impact of an Implementation Strategy Bundle on the adoption of a combined lifestyle intervention in multiple community care settings: A hybrid type III stepped wedge implementation effectiveness trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-12-08 07:07:32","doi":"10.21203/rs.3.rs-8057231/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorInvitedReview","content":"","date":"2026-04-06T12:30:04+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"304789847550667740209337838267025857820","date":"2026-03-24T08:29:21+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"135411213599330245217184916789068464819","date":"2025-12-02T23:03:30+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-12-02T18:55:22+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-12-01T13:05:48+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-11-20T04:39:12+00:00","index":"","fulltext":""},{"type":"submitted","content":"Implementation Science Communications","date":"2025-11-07T12:38:07+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"implementation-science-communications","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"iscm","sideBox":"Learn more about [Implementation Science Communications](https://implementationsciencecomms.biomedcentral.com)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/ISCM/default.aspx","title":"Implementation Science Communications","twitterHandle":"@ImplementSci","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"7a262559-f45f-4dce-9b8f-fbc89e474ce2","owner":[],"postedDate":"December 8th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2025-12-08T07:07:33+00:00","versionOfRecord":[],"versionCreatedAt":"2025-12-08 07:07:32","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8057231","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8057231","identity":"rs-8057231","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}