Oral nutritional supplement combined with an online resistance training programme to improve physical function and nutritional status in older adults receiving home care and at risk of sarcopenia:  protocol for the randomised controlled POWER trial

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The POWER trial protocol describes a randomized controlled study evaluating whether combining an oral nutritional supplement with an online resistance training program improves physical function and nutritional status in older adults receiving home care who are at risk of sarcopenia. The paper outlines participant targeting, intervention components, and planned outcome assessments to compare the combined approach against an appropriate control condition. A key limitation noted in the protocol context is that, as a study design report, it does not provide effectiveness results yet, so conclusions about benefit or harm cannot be drawn from the publication itself. This paper does not explicitly discuss endometriosis or adenomyosis; it was included in the corpus via a keyword match in the upstream search index.

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Abstract

Background The aim of the POWER trial is to investigate the effects of a whey protein oral nutritional supplement (ONS) combined with an online resistance training (RT) programme compared to RT alone on physical function, nutritional status and health-related outcomes in community-dwelling older adults receiving supportive home care who are at risk of sarcopenia. Methods This home-based, randomised controlled trial will include older adults aged ≥70 years, receiving supportive home care (professional and/or informal), who will be screened for sarcopenia via telephone. Forty-six participants will be randomised into either (i) ONS + RT or (ii) RT only trial arms. Participants in the ONS + RT group will be provided with a whey protein ONS enriched with leucine and vitamin D to consume twice a day for 12 weeks. All participants will be provided with an online RT programme twice a week via Zoom. The primary outcomes are physical function, measured using the Timed Up and Go test and nutritional status, measured using the Mini-Nutritional Assessment-Full Form. Secondary outcomes include body composition, dietary intake, gait speed, muscle strength, cognitive function, depression risk, activities of daily living, quality of life and feasibility of intervention implementation. All outcomes will be measured at baseline, after and 12 weeks post-intervention. Conclusion This study will provide data on the effectiveness of a whey protein ONS enriched with leucine and vitamin D combined with an online RT programme delivered via Zoom, compared to the RT programme alone, for older adults at risk of sarcopenia and receiving supportive home care. Trial registration NCT05688956 ; registered December 2022.
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Fallon" }, { "@type": "Person", "name": "Caitriona G. Cunningham" }, { "@type": "Person", "name": "Katy Horner" }, { "@type": "Person", "name": "Clare A. Corish" } ], "publisher": { "@type": "Organization", "name": "HRB Open Research", "logo": { "@type": "ImageObject", "url": "https://hrbopenresearch.org/img/AMP/HRB_image.png", "height": 566, "width": 60 } }, "image": { "@type": "ImageObject", "url": "https://hrbopenresearch.org/img/AMP/HRB_image.png", "height": 1200, "width": 127 }, "description": " Background The aim of the POWER trial is to investigate the effects of a whey protein oral nutritional supplement (ONS) combined with an online resistance training (RT) programme compared to RT alone on physical function, nutritional status and health-related outcomes in community-dwelling older adults receiving supportive home care who are at risk of sarcopenia. Methods This home-based, randomised controlled trial will include older adults aged ≥70 years, receiving supportive home care (professional and/or informal), who will be screened for sarcopenia via telephone. Forty-six participants will be randomised into either (i) ONS + RT or (ii) RT only trial arms. Participants in the ONS + RT group will be provided with a whey protein ONS enriched with leucine and vitamin D to consume twice a day for 12 weeks. All participants will be provided with an online RT programme twice a week via Zoom. The primary outcomes are physical function, measured using the Timed Up and Go test and nutritional status, measured using the Mini-Nutritional Assessment-Full Form. Secondary outcomes include body composition, dietary intake, gait speed, muscle strength, cognitive function, depression risk, activities of daily living, quality of life and feasibility of intervention implementation. All outcomes will be measured at baseline, after and 12 weeks post-intervention. Conclusion This study will provide data on the effectiveness of a whey protein ONS enriched with leucine and vitamin D combined with an online RT programme delivered via Zoom, compared to the RT programme alone, for older adults at risk of sarcopenia and receiving supportive home care. Trial registration NCT05688956; registered December 2022. 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Oral nutritional supplement combined with an online resistance training programme to improve physical function and nutritional status in older adults receiving home care and at risk of sarcopenia: protocol for the randomised controlled POWER trial [version 1; peer review: awaiting peer review] . HRB Open Res 2025, 8 :41 ( https://doi.org/10.12688/hrbopenres.14086.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Oral nutritional supplement combined with an online resistance training programme to improve physical function and nutritional status in older adults receiving home care and at risk of sarcopenia: protocol for the randomised controlled POWER trial [version 1; peer review: awaiting peer review] Catherine M. Fallon https://orcid.org/0009-0000-7408-7661 1,2 , Caitriona G. Cunningham https://orcid.org/0000-0002-8916-9499 1 , Katy Horner https://orcid.org/0000-0002-5046-3658 1,2 , Clare A. Corish 1,2 Catherine M. Fallon https://orcid.org/0009-0000-7408-7661 1,2 , Caitriona G. Cunningham https://orcid.org/0000-0002-8916-9499 1 , Katy Horner https://orcid.org/0000-0002-5046-3658 1,2 , Clare A. Corish 1,2 PUBLISHED 17 Mar 2025 Author details Author details 1 UCD School of Public Health, Physiotherapy and Sports Science, University College Dublin, Belfield, Dublin 4, Ireland 2 UCD Institute of Food and Health, University College Dublin, Belfield, Dublin 4, Ireland Catherine M. Fallon Roles: Conceptualization, Data Curation, Investigation, Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Caitriona G. Cunningham Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Resources, Supervision, Visualization, Writing – Review & Editing Katy Horner Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Resources, Supervision, Visualization, Writing – Review & Editing Clare A. Corish Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Supervision, Visualization, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS This article is included in the Ageing Populations collection. Abstract Background The aim of the POWER trial is to investigate the effects of a whey protein oral nutritional supplement (ONS) combined with an online resistance training (RT) programme compared to RT alone on physical function, nutritional status and health-related outcomes in community-dwelling older adults receiving supportive home care who are at risk of sarcopenia. Methods This home-based, randomised controlled trial will include older adults aged ≥70 years, receiving supportive home care (professional and/or informal), who will be screened for sarcopenia via telephone. Forty-six participants will be randomised into either (i) ONS + RT or (ii) RT only trial arms. Participants in the ONS + RT group will be provided with a whey protein ONS enriched with leucine and vitamin D to consume twice a day for 12 weeks. All participants will be provided with an online RT programme twice a week via Zoom. The primary outcomes are physical function, measured using the Timed Up and Go test and nutritional status, measured using the Mini-Nutritional Assessment-Full Form. Secondary outcomes include body composition, dietary intake, gait speed, muscle strength, cognitive function, depression risk, activities of daily living, quality of life and feasibility of intervention implementation. All outcomes will be measured at baseline, after and 12 weeks post-intervention. Conclusion This study will provide data on the effectiveness of a whey protein ONS enriched with leucine and vitamin D combined with an online RT programme delivered via Zoom, compared to the RT programme alone, for older adults at risk of sarcopenia and receiving supportive home care. Trial registration NCT05688956 ; registered December 2022. READ ALL READ LESS Keywords older adults, home care, sarcopenia, oral nutritional supplement, online resistance training Corresponding Author(s) Catherine M. Fallon ( [email protected] ) Close Corresponding author: Catherine M. Fallon Competing interests: No competing interests were disclosed. Grant information: This work was supported by Nutricia Ireland Limited. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2025 Fallon CM et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Fallon CM, Cunningham CG, Horner K and Corish CA. Oral nutritional supplement combined with an online resistance training programme to improve physical function and nutritional status in older adults receiving home care and at risk of sarcopenia: protocol for the randomised controlled POWER trial [version 1; peer review: awaiting peer review] . HRB Open Res 2025, 8 :41 ( https://doi.org/10.12688/hrbopenres.14086.1 ) First published: 17 Mar 2025, 8 :41 ( https://doi.org/10.12688/hrbopenres.14086.1 ) Latest published: 20 Jan 2026, 8 :41 ( https://doi.org/10.12688/hrbopenres.14086.3 )  There is a newer version of this article available. Suppress this message for one day. Background Muscle loss is caused by a discrepancy between muscle protein synthesis and muscle protein breakdown 1 , which can be contributed to by ageing, inadequate nutrition and physical inactivity 2 , 3 . Sarcopenia is an age-related condition defined by the European Working Group on Sarcopenia for Older People (EWGSOP) as low muscle strength, mass and physical function 1 . This can lead to reduced ability to carry out activities of daily living (ADLs), falls, loss of independence, hospitalisation, disability and death 4 , 5 . When physical function significantly deteriorates, supportive formal or informal home care to perform ADLs may be required 6 , 7 . Currently, the reported prevalence of sarcopenia among community-dwelling older adults (≥60 years) ranges from 5–10% 8 – 10 . Within residential care homes, reported sarcopenia prevalence is between 17–73%, and from 22–87% within assisted living facilities 11 . Older adults’ response to protein 12 – 14 and resistance training (RT) 2 , 15 is blunted compared to the response of healthy younger populations. With reduced mobility, anabolic resistance is further exacerbated in older adults 13 , 16 . The relationship between sarcopenia and undernutrition is complex, with the development of one interlinked with the other 2 , 5 . Undernutrition, mainly when there is insufficient energy and/or protein, contributes to muscle protein breakdown 3 , 5 . Older community-dwelling adults receiving home care are more frequently undernourished [14.9%, 95% CI: 9.9–20% compared to those not requiring home care 4.7%, 95% CI: 3.6–6.1%] 17 . To increase muscle strength and mass, nutritional interventions and/or RT are recommended 18 , 19 . The functional benefits of taking part in RT include improved mobility, performance in ADLs, resistance to injuries and falls and enhanced overall quality of life in older adults 20 – 23 , . Mobility limitations can persist in individuals who are at a higher risk of lower protein intake (<0.8 g/kg adjusted bodyweight/day) 24 . Older females, with higher BMI and poor appetite are at higher risk of inadequate protein intakes 25 . Increasing energy 26 , 27 and protein (1–1.5 g/kgBW/day) 26 – 28 intakes to prevent malnutrition and muscle loss is recommended for older adults 26 – 28 . To further stimulate muscle protein synthesis, increasing leucine intake by up to 2.8–3 g twice/day is recommended 29 , 30 . Older adults residing in the Northern Hemisphere should also take a daily vitamin D supplement (15 µg for healthy older adults and 20 µg for home bound older adults) 19 , 31 – 33 . Providing ONS fortified with whey protein, leucine and vitamin D has shown promise in improving health-related outcomes 34 , 35 while such ONS combined with RT in older adults with sarcopenia have shown positive effects on muscle strength, body composition and physical function 34 . Older adults with sarcopenia, undergoing physical rehabilitation, demonstrated improvements in physical function [Timed Up & Go (TUG) and gait speed) and nutritional status (Mini-Nutritional Assessment-Full Form (MNA-FF)] following 8 weeks of ONS enriched with leucine and vitamin D and supervised RT compared to an isocaloric placebo supplementation and supervised RT 36 . These findings demonstrate the added benefits of nutritional supplementation to improve outcomes of an exercise programme in hospitalised older adults. However, whether similar effects are observed in older adults receiving supportive home care is unknown. Older adults with sarcopenia are recommended to perform at least two RT sessions per week 18 , 37 . Given that a number of studies indicate older adults are less likely to engage in exercise programmes for varying reasons 38 , 39 , supervised exercise programmes delivered via an online platform are worth considering 40 , 41 . Online platforms such as Zoom provide a potential and accessible solution for older adults who have mobility and/or transportation limitations 41 – 43 . Providing a supervised and consistent programme can improve adherence 44 plus the group-based aspect can provide a social element 41 . Recent studies indicate overall acceptability of online exercise programmes among healthy older adults 41 , 44 . Therefore, the aim of this study is to test the effectiveness of a novel whey protein ONS enriched with leucine and vitamin D (Fortimel Advanced, Nutricia) combined with an online RT programme versus the RT programme alone on the physical function and nutritional status of older adults who are at risk of sarcopenia and receiving supportive home care. The primary outcomes of the study are 1) physical function as measured by the TUG and 2) nutritional status as measured by the MNA-FF. Trial registration: NCT05688956 ; registered December 2022. Methods Study design This randomised, parallel group, 12-week clinical trial will include 46 community-dwelling (residing in either an urban or rural setting in their own home) older adults who receive supportive home care and are at risk of sarcopenia. Participants will be randomly allocated to either the (i) ONS + RT or (ii) RT only trial arm. Screening potential participants will be undertaken via telephone. Baseline and follow-up assessments will be undertaken in the participant’s own home. Post-intervention testing will be conducted immediately after the final RT session and again 12 weeks later. The study design and participant flow chart are shown in Figure 1 45 . Figure 1. Study design and participant flow. Sample size Study sample size calculation was conducted in G* Power (version 3.1). Based on previous study findings 36 , 15 participants per group are required to detect a mean difference of 3.7 seconds in time to complete TUG with 80% power and significance at p<0.05. Additionally, based on the same findings 36 , 16 participants per group will be needed to detect a mean difference of 1.52 in MNA-FF score between the intervention group and the control group with 80% power and significance at p<0.05. To ensure an adequate sample size to enable per protocol analysis, the sample size was increased to 23 participants per group 46 . This will allow for both intention-to-treat and per-protocol analyses, ensuring rigorous analysis of intervention effectiveness. Eligibility criteria, recruitment and screening Older adults who are ≥70 years old, community-dwelling and receiving regular supportive home care from a professional and/or informal carer 47 will be invited to take part in the research study. A variety of recruitment techniques will be employed including contacting home care associations, media coverage, poster distributions and face-to-face strategies such as presenting at community centres, day centres and exhibition shows for older adults. Non-profit organisations and charities that support older adults will also be contacted and asked to share information about the study. The inclusion and exclusion criteria are summarised in Table 1 . Individuals will be screened for eligibility using two screening questionnaires conducted via telephone: i) SARC-F questionnaire with a cut-off score of ≥1 (out of 10) to screen for risk of sarcopenia 48 ( Table 1 ) and ii) the Physical Activity for Readiness Questionnaire for Everyone (PARQ+) to assess participants’ readiness to participate in exercise. Table 1. Inclusion and exclusion criteria for the POWER Study. Inclusion Criteria Exclusion Criteria 1. Older adults (70+ years) 2. Community-dwelling 3. Receiving supportive home care (professional and/or informal) 4. At risk of sarcopenia (SARC-F ≥1) 48 1. Cognitive impairment (MMSE <24) 49 2. Severe kidney disease (glomerular filtration rate <30 mL/min) 3. Moderate to severe liver disease (Child-Pugh class B or C) 4. Psychiatric disorder 5. Receiving active treatment or palliative care for cancer 6. Receiving enteral or parenteral nutrition 7. Known hypersensitivity to any component of the ONS 8. Currently consuming ONS 9. Allergic to dairy products 10. Regularly undertaking resistance training 11. Advised by GP not to undertake exercise Randomisation and blinding On meeting the eligibility criteria, participants will be randomised into either the (i) ONS + RT or (ii) RT only, using a 1:1 ratio by an independent researcher not involved in the POWER study using the Clinical Trial Randomization Tool hosted by the National Cancer Institute . Eligible participants will be assigned an identification number and then added to the study database. It will not be possible to blind the participant or researchers to the intervention allocation. Interventions Oral Nutritional Supplements Participants randomised to ONS + RT will consume two 200 mL bottles of whey-based protein ONS enriched with the amino acid leucine and vitamin D each day 50 . Participants will be instructed to consume the ONS as soon as possible after the RT session and on non-exercise days, the most appropriate time for consumption to optimise potential muscle protein synthesis will be based on a 24-hour dietary recall, undertaken at the baseline assessment 51 . The nutritional content of the ONS (Fortimel Advanced, Nutricia) per 200 mL includes: energy: 300 kcal; protein: 20.8 g; leucine: 3 g; fat: 10.4 g; carbohydrate: 30 g; dietary fibre: 2.8 g; vitamin D: 10 µg (Appendix B) 45 . Dietary advice All participants and home support person, if required, will be provided with written dietary information (“ Making the Most of Every Bite ”, a high energy and protein cookbook, available from the Irish Health Service Executive). Additional dietary advice will be provided verbally. Online resistance training programme A 12-week, progressive, group RT programme, developed with a registered physiotherapist and an exercise physiologist, will be delivered to all participants in their own home via Zoom twice per week by a health science researcher with exercise training (Exercise Instructor). Each RT session will last approximately 45–60 minutes, will include a warm-up and cool-down and moderate to high intensity RT exercises rated on the 10 point Borg Rating of Perceived Exertion (RPE) scale 52 . During the baseline assessment, the exercises will be demonstrated, and the appropriate RT load will be determined using the 5- Repetition Maximum method 53 . The RT programme will include upper and lower body strengthening exercises, which can be modified to each participant’s muscle function, aiming for 2–3 sets of 8–12 repetitions. Exercises include sit-to-stand, shoulder press, bicep curl, calf raise, leg extension and lateral arm raise. Throughout the sessions, the exercise conducted, weight lifted during the exercise, sets and repetitions performed and RPE will be recorded ( Table 2 ). Table 2. Progression plan from week 1 to 12 for the resistance training programme (2 sessions/week). Phase Week Intensity Duration Repetitions Sets Exercise Phase 1 Week 1–2 Easy-moderate 45 minutes * 8–10 2–3 Sit-to-stand, Shoulder press, Bicep curl, Calf raise Phase 2 Week 3–5 Easy-hard 45–50 minutes * 10–12 3 Sit-to-stand, Shoulder press, Bicep curl, Calf raise Phase 3 Week 6–8 Moderate-hard 60 minutes * 12 3 Sit-to-stand, Shoulder press, Bicep curl, Calf raise, Leg extension, Lateral arm raise Phase 4 Week 9–12 Moderate-hard 60 minutes * 12 3 Sit-to-stand, Shoulder press, Bicep curl, Calf raise, Leg extension, Lateral arm raise *Rest period is the same throughout the whole programme: 1–2 minutes between sets; 2–3 minutes between exercises and at least 48 hours between sessions Data collection Initial screening data will be collected over the telephone, which will capture home care status, SARC-F score, MNA-short form score, and demographic data. Written informed consent will be obtained at the baseline assessment in the participant’s home (Appendix C) 45 . Outcome data will be collected at baseline (T1), post-intervention (T2) and 12-weeks post-intervention (T3) in the participant’s home and will be recorded on an online form (Google Forms). If required, assistance with data collection will be provided by the participant’s home carer. Adherence to the ONS will be recorded post-intervention. Adherence to the RT programme will be monitored and recorded throughout the study intervention (T2) ( Table 3 ). Table 3. Measures at the three study timepoints. TIMEPOINT T1 Baseline T2 Post-intervention T3 12 weeks post- intervention ENROLMENT Eligibility ☒ Randomisation ☒ Written informed consent ☒ OUTCOMES Timed Up & Go ☒ ☒ ☒ Mini Nutritional Assessment-Full Form ☒ ☒ ☒ Body composition ☒ ☒ ☒ Dietary recall ☒ ☒ ☒ 4-metre gait speed ☒ ☒ ☒ Handgrip strength ☒ ☒ ☒ Five times Sit-To-Stand ☒ ☒ ☒ Cognitive function ☒ ☒ ☒ Depression risk ☒ ☒ ☒ Activities of daily living ☒ ☒ ☒ Quality of life ☒ ☒ ☒ Number of participants recruited ☒ Number of participants retained ☒ ☒ Adherence to oral nutritional supplement ☒ Adherence to resistance training ☒ Acceptability of oral nutritional supplement ☒ Acceptability of resistance training ☒ Study outcomes Primary outcomes The primary study outcomes are the mean difference in TUG (seconds) and MNA-FF score between the ONS + RT group and the RT only group after the 12-week intervention, using the validated TUG 54 and MNA-FF assessment tools 55 . Timed Up and Go Participants will be timed when asked to stand up from a standardised armchair (46 cm seat height), walk 3 metres, turn around, walk back and sit down 54 . The use of a walking aid will be permitted. The following reference values will be used: 9.2 (8.2–10.2) seconds for 70 to 79 years, and 11.3 (10–12.7) seconds for 80 to 99 years 56 . A cut-off time of 20 seconds 1 or those unable to complete the TUG due to health problems will be considered low physical function 57 . The TUG has demonstrated good inter-rater and intra-rater (intraclass correlation coefficient = 0.99) reliability 54 . Mini-Nutritional Assessment-Full Form The MNA-FF will be used to assess the nutritional status of participants. The MNA-FF includes 18 questions to assess an individual’s nutritional status 55 . The MNA-FF includes anthropometric measures and questions on general health status, dietary habits and self-perceived health and nutrition status 58 . A score of 24–30 indicates that an individual is normally nourished, 17–23.5 that an individual is at risk for malnutrition, and a score of <17 that the person is malnourished 55 . The MNA-FF has demonstrated high sensitivity (96%), specificity (98%), and predictive value (97%) in accurately identifying the nutritional status of older adults compared to clinical assessment 59 . Secondary outcomes Body composition Height will be measured with a stadiometer, with shoes removed. In participants who are unable to stand, height will be estimated by measuring ulna (forearm) length (cm) with reference to predictive equations 60 . For ulna length, the distance between the olecranon process and the midpoint of the prominent bone of the wrist (styloid process) will be measured with the left arm folded across the chest with the fingers pointing towards the shoulder 60 , 61 . Participants’ body composition [fat (kg/%), muscle (kg/%), and weight (kg) and BMI (kg/m 2 )] will be assessed using the Tanita MC-780MA (2015, Tanita Corporation, Japan), an 8 electrode multi-frequency segmental body composition analyser 62 , 63 . Calf and mid-upper arm (MUAC) circumferences will be measured. Calf circumference will be measured with a non-elastic measuring tape using the widest part of the calf 64 . MUAC will be measured using the same tape, at the midpoint between the acromial process of the shoulder and the olecranon process of the elbow with the arm hanging relaxed at the participant’s side 65 . Measurements will be taken while seated. Dietary intake A 24-hour dietary recall using a multiple pass technique will be conducted at each home-based assessment to establish the dietary pattern of each participant. Participants will be asked to recall all foods and drinks consumed in the previous 24 hours, commencing with first intake of food or drink of the day. Any dietary supplement(s) consumed will also be recorded. The list of foods will be repeated back to the participant, and using closed questions, each participant will be asked about foods frequently omitted (e.g., sauces, dressings, beverages, sweeteners, etc.), timing of meals and additional snacks. A detailed description of food consumed (type, brand, weight) will be recorded. The dietary intake data will be reviewed for a third time with the participant to validate the information. The 24-hour dietary recall data will be analysed using Nutritics TM software (version 5.96). Intakes of protein (g) and energy (kilocalorie) will be calculated as g/kgBW and as kilocalorie/kgBW respectively. Changes in macro and micronutrient intakes between all three timepoints will be assessed. Gait speed Gait speed will be measured using 4-metre (m) gait speed. A 4-m flat and unobstructed course will be marked out by tape. Participants will be asked to walk at their usual speed. Once the participant’s foot is across the finish line, the time taken to complete the course will be recorded 66 , 67 . Muscle strength Handgrip strength will be measured as an indicator of upper limb muscle strength using a dynamometer (Jamar hydraulic hand dynamometer) 68 . Participants will be asked to squeeze the dynamometer handle with force, with the arm at a 90-degree angle in the seated position. Each participant will complete the test three times with each hand to get an average 68 . The 2019 EWGSOP cut-offs to define low handgrip strength (<27 kg for males and <16 kg for females) will be used 1 . The Five times Sit-To-Stand (5xSTS) will be used to assess lower limb muscle strength 69 . Participants will be asked to stand from the chair five times as quickly as possible and the time taken to complete the assessment will be recorded 69 . Using the 2019 EWGSOP cut-off, low muscle strength will be defined as >15 seconds 1 . Cognitive function, depression risk and activities of daily living Cognitive function will be measured with the Mini-Mental State Examination (MMSE) 49 . Cognitive function impairment is defined as a score <24 points and such individuals will be excluded from the study 70 . The Geriatric Depression Scale (GDS-15) will be used to screen for depression risk 71 . This scale assigns scores of zero or one to each response, with a score >5 indicating the presence of depression 71 . The ability of participants to perform ADLs will be assessed using the Katz Index of Independence in ADLs 72 . This Index assesses six functional activities: bathing, dressing, toileting, transferring, continence and feeding 72 . Quality of life Quality of life will be assessed using the Short Form (SF)-12 × 2 ® 73 . This instrument uses twelve questions to assess perceived general health (physical and social function, pain, emotion and mental health) 73 . Feasibility of intervention implementation Recruitment and Retention Recruitment rate will be defined as the percentage of eligible participants who consent to participate in the research study (total number of participants recruited divided by the total number of people screened for eligibility multiplied by 100). Retention rate will be defined as the percentage of participants who start and go on to complete the study intervention. The number of participants who complete the follow-up assessment (T3) will also be recorded. Reasons for study dropout will be recorded. Adherence to oral nutritional supplement Participants will be asked to self-report intake of ONS per day using a paper copy ONS recording sheet that provides instructions on how to consume the ONS. Participants will check two tick boxes to indicate they have consumed two ONS on the day of consumption and tick one box if only one ONS is consumed. If they have not completely consumed a bottle, they will be asked to record this for the specific day. Participants will be asked to retain both used and unused ONS bottles; these will be counted at the end of the intervention. Adequate adherence will be defined as consuming an average of 10 out of 14 (71%) ONS per week over the 12-week intervention 74 . Reasons for non-adherence will be recorded. Adherence to resistance training Adherence during the supervised RT session will be monitored by the Exercise Instructor who will record attendance, number of repetitions, sets, weight used, and the RPE on the study online recording database. Adequate adherence will be defined as successfully participating in 18 out of 24 sessions (>75%) 75 . Reasons for non-adherence will be recorded. Acceptability of the oral nutritional supplement Acceptability of the ONS will be assessed post-intervention with three questions using a 9-point Hedonic scale to evaluate flavour, texture, and overall acceptance 76 . Additionally, four questions will utilise a 5-point Hedonic scale to assess visual appearance, smell, taste, and aftertaste of the ONS 76 . Participants will also respond to a final question regarding their willingness to purchase the protein drink, with options ranging from "would certainly buy" to "would certainly not buy" 76 . Acceptability of the resistance training programme A short bespoke questionnaire completed by participants post-intervention will be used to evaluate their perceptions of the RT programme. All questionnaire statements are framed positively, and participants will be asked to rate their agreement with each statement on a five-point Likert scale ranging from “Strongly disagree” to “Strongly agree”. Participants’ responses will be collated and summarised 77 . Adverse events Should an adverse event occur, it will be discussed immediately with the research advisory team (CC, CCu, KH) and participants will be advised to contact their general practitioner as appropriate. As per ethical approval, the occurrence of any unexpected serious adverse event will be reported to the UCD HREC ( [email protected] ). Data management Personal data will be stored in a password protected university database in compliance with the Data Protection Act 2018 78 . Only the researchers will have access to this information. Each participant will be assigned a study identification number, which will be used to pseudonymise the data collected. All data will be pseudonymised for analysis, enabling the potential re-linking of individual participant data for data checking if necessary. All data will be anonymised after four years. transferred to Nutricia Ireland Ltd as per the signed legal agreement between UCD and Nutricia Ireland. Statistical analysis plan Statistical analyses will be performed using SPSS Statistics for Windows, version 27 (SPSS Inc., Chicago, Ill., USA) and RStudio (2023.06.2. Posit, PBC) as appropriate. Data cleaning will be conducted prior to analysis. Demographic data and study primary and secondary outcomes will be described using measures such as mean and standard deviation, median and interquartile range, 95% confidence interval, or count and percentage. Descriptive statistics will also be used to report the feasibility of the intervention. Missing data will not be imputed for the primary analysis. Data will be analysed using the intention-to-treat approach, wherein all participants who have been randomly allocated to the study intervention 79 will be included. The primary outcome is the mean difference in the change of TUG (seconds) and MNA-FF scores between the ONS + RT group and the RT only group following the completion of the 12-week intervention. Between-group linear mixed-model analysis will be used to assess the mean difference in change from baseline to post-intervention. The dependent variables will be TUG and MNA-FF with group (ONS + RT, RT), time (baseline, post-intervention), and the group-by-time interaction as fixed factors; participant ID as a random factor; and baseline values as covariates. To establish the minimal clinically important differences for TUG and MNA-FF scores, distribution-based methods will be employed 80 . The standard deviation of TUG times and MNA-FF scores from pre- and post-intervention measurements will be calculated to assess variability. The effect size (Cohen’s d) will be determined using the mean difference and standard deviation. Residuals will be tested for normality, and transformations will be applied as needed to address non-normal data distribution. Using the same approach as above, between-group differences and within-group differences at baseline, after, and 12 weeks post-intervention will be analysed for secondary outcomes. A per-protocol analysis will also be conducted, including participants who adhered to the intervention and have baseline and post-intervention measurements 81 . A p-value of less than 0.05 will be considered statistically significant. Funding The POWER study is funded by Nutricia Ireland Ltd. The funder will have no role in the study design, conduct, data analysis, interpretation of results or write up of the study findings. A signed legal agreement between UCD and Nutricia Ireland specifies that the purpose of the grant funding is to carry out a study and the funds are to support genuine independent research, advancement of science and education, or patient and public education. Dissemination of findings The study results will be disseminated through peer-reviewed journal article(s) and presented at relevant scientific conferences. The study will be disseminated to healthcare professionals such as community nurses, dietitians, gerontologists and physiotherapists as well as to volunteer organisations for older adults. The results of the study will be reported to the funder (Nutricia Ireland Ltd). Discussion Interventions to improve the physical function and nutritional status of older adults with sarcopenia risk are needed 5 , 82 . The POWER Study aims to evaluate the combined effects of a novel whey protein ONS combined with an online RT programme compared to the RT programme alone on TUG and MNA-FF in community-dwelling older adults at risk of sarcopenia who receive supportive home care. ONS are commonly prescribed in clinical settings to improve dietary energy and/or protein intake in those unable to take adequate nutrition through food sources alone 83 . The ONS provided in this study contains whey protein, shown to stimulate muscle protein synthesis in older adults 84 . It is also enriched with the essential amino acid leucine and vitamin D, both of which have been previously shown to have additional benefits on muscle strength, mass and physical function in older adults 34 , 84 . Two servings per day will enable participants to comply with European Society for Clinical Nutrition and Metabolism guidelines for ONS (600 kcal and 40 g protein daily) 83 . RT is a safe strategy to increase muscle mass, strength and physical function in older adults with sarcopenia 85 . Providing RT online can make exercise more accessible to those who lack transport and, if supervised, can improve adherence since participants are monitored 86 . A recent systematic review and meta-analysis concluded that RT combined with whey protein supplementation in older adults with sarcopenia improved grip strength, increased energy and protein intake and reduced inflammatory markers compared to placebo 87 . Results also showed that whey protein supplementation had a significant effect on gait speed, ADL scores, and blood biomarkers, including albumin, Insulin-like Growth Factor-1 and 25-hydroxyvitamin D 87 . However, given that the studies conducted to date varied in type and intensity of RT, protein supplement quantity and length of intervention, the authors advised that more studies should be conducted to validate their findings and further explore the effects of whey protein and RT in patients with sarcopenia 87 . Furthermore, older adults receiving supportive home care are an often-overlooked cohort in multicomponent interventions 88 . This online RT programme, developed with a registered physiotherapist and exercise physiologist, follows the American College of Sports Medicine guidelines 89 and sarcopenia RT prescription recommendations 18 . This intervention will provide a structured, supervised exercise programme, encouraging participants to stay committed, which will aid adherence 44 . Exercises will be appropriately modified and monitored throughout the intervention. As with other programmes delivered via an online platform, a limitation to this study will be that some older adults will not have access to Zoom (via laptop or tablet), therefore limiting their ability to participate. However, it provides a viable alternative for those unable to access a centre or facility for in-person RT programmes 90 . Assessments 12 weeks post-intervention will examine the long-term effects once the intervention ceases. Although participants may show good adherence to the online RT programme, they may discontinue RT once the programme stops 91 . Therefore, the sustained effects of the interventions on physical function, nutritional status and health-related outcomes will be examined 12 weeks post-intervention. A limitation of this study includes lack of a placebo supplement; therefore, intervention blinding will not be possible. A specific stipulation by the UCD Ethics Committee, given the vulnerability of the study population, was that dietary advice should be provided to all participants to promote an increase of dietary protein through food sources. Providing dietary advice to all participants may act as a confounding factor, making it challenging to isolate the effects of the ONS from changes due to the dietary advice. In addition, as both groups are undertaking the online RT programme, following a similar design to previous research in a vulnerable population 36 , the effectiveness of the RT programme alone compared to no exercise is not possible to determine. However, in addition to the primary analysis comparing the outcomes between ONS + RT versus RT alone, the statistical approach will allow for main effects of time to be identified across both groups, which can be interpreted in relation to minimal clinically important differences. Furthermore, collecting biomarkers of muscle protein synthesis or 25-hydroxyvitamin D (25(OH)D) level will not be possible. Older adults who are housebound in Ireland are recommended a daily supplement of 20 µg of vitamin D, due to limited sun exposure and insufficient intake through food 33 . Hence, participants currently taking vitamin D supplements will not be excluded from the current study. Conclusion In summary, the POWER Study will provide data on the effectiveness and feasibility of an ONS combined with a 12-week online RT programme compared to the RT programme alone, in older adults with sarcopenia risk who receive supportive home care. It will also provide information on whether any changes observed following the intervention are maintained, 12 weeks post intervention. This will contribute to knowledge of how these interventions affect physical function and nutritional status and inform future research and practice. Ethics Declaration of Helsinki The study will be conducted in compliance with the Helsinki declaration 92 . Approvals Ethics and consent to participate: The study was submitted for ethical approval to the UCD Human Research Ethics Committee (HREC) on 24 October 2022. Following review and addressing queries, the study was approved (LS-22-59-Corish) on 31 January 2023. The POWER study was registered on ClinicalTrials.gov (NCT05688956) in December 2022. To broaden recruitment within the Irish Health Service Executive (HSE), the study was submitted to and approved by the Clinical Research Ethics Committee Galway (C.A 3058; 6 July 2023) for Community Healthcare Organisation (CHO) area 2 (Co. Galway, Co. Roscommon and Co. Mayo, Ireland) and by the HSE Research Ethics Committee Midlands Area and Corporate (Co. Wicklow, Dun Laoghaire, Dublin South East, Co. Laois, Co. Offaly, Co. Longford, Co. Westmeath, Co. Louth and Co. Meath, Ireland) (RRECB1023CC; on 17 January 2024). Adverse events will be recorded and reported to the UCD and relevant ethics committees. Written informed consent will be obtained at the baseline assessment in the participant’s home prior to any study related procedures being undertaken. The consent form is available at the UCD Research Data Zenodo Community repository (Appendix C) 45 . Declaration of Generative AI and AI-assisted technologies in the writing process The authors declare that they have not used Generative AI and AI-assisted technologies in the writing process. Data availability Underlying data No data are associated with this article. Extended data Zenodo: Protein Supplement and Exercise Training for the Treatment of Sarcopenia Risk in Older Adults (POWER), https://doi.org/10.5281/zenodo.14856935 45 . This project contains the following extended data: - SPIRIT checklist - Nutritional content of the ONS - Participant consent form - Study design and participant flow figure Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). Reporting guidelines UCD Research Data Zenodo Community: This protocol study will be reported following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) with a summary checklist reported (Appendix A) for ‘Oral nutritional supplement combined with an online resistance training programme to improve physical function and nutritional status in older adults receiving home care and at risk of sarcopenia: protocol for the randomised controlled POWER trial’ https://doi.org/10.5281/zenodo.14856935 45 . Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). Author roles Fallon C.M.: Conceptualisation, Data Curation, Investigation, Methodology, Project Administration, Visualisation, Writing – Original Draft Preparation, Writing – Review & Editing Cunningham C.G.: Conceptualisation, Funding Acquisition, Investigation, Methodology, Resources, Supervision, Visualisation, Writing – Review & Editing Horner K.: Conceptualisation, Funding Acquisition, Investigation, Methodology, Resources, Supervision, Visualisation, Writing – Review & Editing Corish C.A.: Conceptualisation, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Supervision, Visualisation, Writing – Review & Editing Faculty Opinions recommended References 1. Cruz-Jentoft AJ, Bahat G, Bauer J, et al. : Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019; 48 (1): 16–31. PubMed Abstract | Publisher Full Text | Free Full Text 2. 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Comments on this article Comments (0) Version 3 VERSION 3 PUBLISHED 17 Mar 2025 ADD YOUR COMMENT Comment Author details Author details 1 UCD School of Public Health, Physiotherapy and Sports Science, University College Dublin, Belfield, Dublin 4, Ireland 2 UCD Institute of Food and Health, University College Dublin, Belfield, Dublin 4, Ireland Catherine M. Fallon Roles: Conceptualization, Data Curation, Investigation, Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Caitriona G. Cunningham Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Resources, Supervision, Visualization, Writing – Review & Editing Katy Horner Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Resources, Supervision, Visualization, Writing – Review & Editing Clare A. Corish Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Supervision, Visualization, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information This work was supported by Nutricia Ireland Limited. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (3) version 3 Revised Published: 20 Jan 2026, 8:41 https://doi.org/10.12688/hrbopenres.14086.3 version 2 Revised Published: 06 Nov 2025, 8:41 https://doi.org/10.12688/hrbopenres.14086.2 version 1 Published: 17 Mar 2025, 8:41 https://doi.org/10.12688/hrbopenres.14086.1 Copyright © 2025 Fallon CM et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics VIEWS $counts.viewCount downloads Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Fallon CM, Cunningham CG, Horner K and Corish CA. Oral nutritional supplement combined with an online resistance training programme to improve physical function and nutritional status in older adults receiving home care and at risk of sarcopenia: protocol for the randomised controlled POWER trial [version 1; peer review: awaiting peer review] . HRB Open Res 2025, 8 :41 ( https://doi.org/10.12688/hrbopenres.14086.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: AWAITING PEER REVIEW AWAITING PEER REVIEW ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Comments on this article Comments (0) Version 3 VERSION 3 PUBLISHED 17 Mar 2025 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 2 Version 3 (revision) 20 Jan 26 read Version 2 (revision) 06 Nov 25 read read Version 1 17 Mar 25 Anne Griffin , University of Limerick, Limerick, Ireland Miriam E Clegg , University College Cork School of Food and Nutritional Sciences (Ringgold ID: 374114), Cork, Ireland Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2026 Griffin A. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 21 Jan 2026 | for Version 3 Anne Griffin , University of Limerick, Limerick, Ireland 0 Views copyright © 2026 Griffin A. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions No further comments to make. Competing Interests No competing interests were disclosed. Reviewer Expertise My research interests focus on the development and optimisation of nutrition care pathways for older adults, aiming to enhance their health outcomes and quality of life. I am particularly interested in addressing the challenges of food security within the realm of public health nutrition, exploring innovative strategies to ensure that all individuals have access to adequate, nutritious food. By examining the intersection of nutrition care and food security, I aim to contribute to the creation of comprehensive, equitable public health policies and practices that support the well-being of older populations. reply Respond to this report Responses (0) Griffin A. Peer Review Report For: Oral nutritional supplement combined with an online resistance training programme to improve physical function and nutritional status in older adults receiving home care and at risk of sarcopenia: protocol for the randomised controlled POWER trial [version 1; peer review: awaiting peer review] . HRB Open Res 2025, 8 :41 ( https://doi.org/10.21956/hrbopenres.15781.r52999) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/8-41/v3#referee-response-52999 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Clegg M. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 27 Dec 2025 | for Version 2 Miriam E Clegg , Food and Nutritional Sciences, University College Cork School of Food and Nutritional Sciences (Ringgold ID: 374114), Cork, County Cork, Ireland 0 Views copyright © 2025 Clegg M. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions This is an interesting article that presents a protocol for a randomized controlled trial using resistance exercises and dietary protein on physical function (Timed Up and Go) and nutritional status (Mini-Nutritional Assessment-Full Form) as well as health outcomes in older adults in the community who are receiving homecare. The authors provide clear rationale highlighting that this type of intervention has been successful in the hospitalised older adult, but it is not clear if it would be successful in community dwelling older adults who are receiving homecare. In this situation providing an exercise intervention that meets the needs of the older adults can be difficult which makes this online intervention novel. The article is well written and makes good use of current evidence. The abstract background could be improved by including a short rationale for the work if there is space. Will any data be collected on qualitative aspects of the intervention outside of the questionnaire (e.g. focus group or open-ended questions? It would be interesting to see how much the older adults enjoyed the exercise intervention, how they would see it improved and if technology and lack of in-person support was a barrier. Will the participants be given any instructions on continuing the exercise on their own after the intervention? It isn’t very clear what happens between T2 and T3. Will the research data be made openly available? There are details on protocol data but I couldn’t see research data – apologies if I missed it. My congratulations on the project, I hope that everything goes well and I look forward to seeing the results. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise Nutrition and healthy ageing reply Respond to this report Responses (1) Author Response 20 Jan 2026 Catherine Fallon, UCD School of Public Health, Physiotherapy and Sports Science, University College Dublin, Belfield, Dublin 4, Ireland Many thanks for your detailed review of our protocol. We truly appreciate the time and care you put into your feedback. We have addressed all comments and have updated the protocol to reflect your suggestions. The abstract background could be improved by including a short rationale for the work if there is space. Thank you for this suggestion which was also made by Reviewer 1. We have now added a brief rationale to the abstract on the need for combined nutrition and resistance training interventions in older adults at risk of sarcopenia. [Abstract] Background: Risk of sarcopenia and poor nutritional status are observed in older adults receiving home care. Hence, the aim of the POWER randomised controlled trial is to investigate the effectiveness of a whey protein oral nutritional supplement (ONS) combined with an online resistance training (RT) programme compared to RT alone on physical function, nutritional status and health-related outcomes in community-dwelling older adults receiving supportive home care who are at risk of sarcopenia. 2. Will any data be collected on qualitative aspects of the intervention outside of the questionnaire (e.g. focus group or open-ended questions? It would be interesting to see how much the older adults enjoyed the exercise intervention, how they would see it improved and if technology and lack of in-person support was a barrier. Thank you for raising this point. Yes, qualitative data will be collected at the post-intervention assessment. Acceptability of both the ONS and online RT programme will be assessed using bespoke questionnaires developed by the research team. These will include hedonic and other Likert-scale items alongside optional free text comments. The free text comments will be analysed using thematic analysis. We have now included this in the analysis plan. [Under statistical analysis plan] Qualitative data analysis plan The free text comments of the acceptability questionnaires will be used to further explore the acceptability of the ONS and online RT intervention and relevant barriers and facilitators to the intervention. Braun and Clarke’s framework of thematic analysis will be used to identify themes and subthemes. This includes familiarisation with the data, creating initial codes, searching for themes, reviewing potential themes and finally, defining themes and subthemes. 3. Will the participants be given any instructions on continuing the exercise on their own after the intervention? It isn’t very clear what happens between T2 and T3. Thank you for highlighting this. Between T2 and T3, participants will not receive the online RT programme. At the T2 assessment, they will be encouraged to continue exercising. We have now clarified this as follows in the RT programme section: [under Online resistance training programme ] Following the T2 post-intervention assessment, participants will not receive the online RT programme. At the T2 assessment, they will be encouraged to continue to exercise but no additional supervised sessions or support will be provided between T2 and T3. 4. Will the research data be made openly available? There are details on protocol data but I couldn’t see research data – apologies if I missed it.Study participants will be informed that their data will be analysed as pseudonymised data to investigate the effects of the intervention on the primary outcomes: functional status as measured by TUG and nutritional status as measured by MNA-FF. They will also be informed that data on secondary outcomes will be analysed i.e., body composition, dietary intake, gait speed, muscle strength, cognitive function, depression risk, activities of daily living, quality of life and feasibility of intervention implementation. The data will be published in appropriate peer-reviewed publications and presented at suitable research conferences. No participant personal data or data that could potentially identify participants will be published. This is now included under Data Management. [Under data management section] Personal data will be stored in a password protected university database in compliance with the Data Protection Act 2018 78 . Only the researchers will have access to this information. Each participant will be assigned a study identification number, which will be used to pseudonymise the data collected. All data will be pseudonymised for analysis, enabling the potential re-linking of individual participant data for data checking if necessary. All data will be anonymised after four years. No personal data will be transferred to Nutricia Ireland Ltd as per the signed legal agreement between UCD and Nutricia Ireland. Study data will be made available to researchers upon reasonable request. My congratulations on the project, I hope that everything goes well and I look forward to seeing the results. We appreciate the reviewer’s positive feedback on our protocol paper. View more View less Competing Interests No competing interests were disclosed. reply Respond Report a concern Clegg ME. Peer Review Report For: Oral nutritional supplement combined with an online resistance training programme to improve physical function and nutritional status in older adults receiving home care and at risk of sarcopenia: protocol for the randomised controlled POWER trial [version 1; peer review: awaiting peer review] . HRB Open Res 2025, 8 :41 ( https://doi.org/10.21956/hrbopenres.15701.r51648) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/8-41/v2#referee-response-51648 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Griffin A. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 20 Nov 2025 | for Version 2 Anne Griffin , University of Limerick, Limerick, Ireland 0 Views copyright © 2025 Griffin A. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Summary of the article: This article describes the protocol for the POWER randomized controlled trial that will evaluate the effectiveness of a fortified, whey protein ONS and online resistance training exercise class among older adults at risk of sarcopenia. The primary outcomes are physical function, nutritional status and health-related outcomes. The novelty of this research is that the cohort are community dwelling older adults in receipt of home care (formal or informal). Thank you for the opportunity to review this article. I have suggestions that I hope support your work. Background: Inclusion of a statement of rationale for the POWER trial would provide some background context, e.g. relevant to sarcopenia. Conclusion: A sentence outlining the significance of any findings from the RCT (why does it matter) could be included. Background: Check grammar as currently unclear if you intend that the ONS product is novel or the approach (ONS and online RT) is novel. I think it is the latter? Methods: Eligibility criteria, recruitment and screening: Please provide a clear rationale for excluding older adults with cognitive impairment from your study. Contemporary guidance emphasises the importance of including this population or, where exclusion is necessary, explaining why and how this decision was made. Dietary intake: Please provide references for the technique described. Discussion: Well written and the limitations of the trial are well considered. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise My research interests focus on the development and optimisation of nutrition care pathways for older adults, aiming to enhance their health outcomes and quality of life. I am particularly interested in addressing the challenges of food security within the realm of public health nutrition, exploring innovative strategies to ensure that all individuals have access to adequate, nutritious food. By examining the intersection of nutrition care and food security, I aim to contribute to the creation of comprehensive, equitable public health policies and practices that support the well-being of older populations. reply Respond to this report Responses (1) Author Response 20 Jan 2026 Catherine Fallon, UCD School of Public Health, Physiotherapy and Sports Science, University College Dublin, Belfield, Dublin 4, Ireland Many thanks for taking the time to review our protocol. We appreciate your thoughtful comments and feedback. We have carefully considered all points raised and have amended the protocol accordingly. Abstract Background: Inclusion of a statement of rationale for the POWER trial would provide some background context, e.g. relevant to sarcopenia. Thank you for this suggestion. We have now added a brief rationale to the abstract on the need for combined nutrition and resistance training interventions in older adults at risk of sarcopenia. We have also amended the Methods section of the abstract to keep within the word count. [Abstract] Background Risk of sarcopenia and poor nutritional status are observed in older adults receiving home care. Hence, the aim of the POWER randomised controlled trial is to investigate the effectiveness of a whey protein oral nutritional supplement (ONS) combined with an online resistance training (RT) programme compared to RT alone on physical function, nutritional status and health-related outcomes in community-dwelling older adults receiving supportive home care who are at risk of sarcopenia. Participants in the ONS + RT group will be provided with a whey protein ONS enriched with leucine and vitamin D to consume twice daily for 12 weeks. All participants will be provided with an online RT programme twice weekly via Zoom. Abstract Conclusion: A sentence outlining the significance of any findings from the RCT (why does it matter) could be included. Thank you for this suggestion. We have added a sentence to the conclusion of the abstract outlining the potential significance of the POWER trial for clinical practice. Conclusion This study will provide data on the effectiveness of a whey protein ONS enriched with leucine and vitamin D combined with an online RT programme compared to the RT programme alone for older adults at risk of sarcopenia and receiving supportive home care. If effective, this combined approach could act as an important strategy to support maintenance of physical function and nutritional status in older adults, for whom home-based interventions are likely a more feasible option. Background: Check grammar as currently unclear if you intend that the ONS product is novel or the approach (ONS and online RT) is novel. I think it is the latter? Thank you for this suggestion. Nutricia refers to the ONS as a novel ONS as it has only been used in clinical trials to date. We have discussed the phrasing as a team and believe that the novelty relates to the approach in the population studied rather than the ONS per se. As such, we think that it is better to omit the use of the word ‘novel’. Background Hence , the aim of this study is to test the effectiveness of a new whey protein ONS, enriched with leucine and vitamin D (Fortimel Advanced, Nutricia) combined with an online RT programme versus the RT programme alone on the physical function and nutritional status of older adults receiving supportive home care who are at risk of sarcopenia." Methods: Eligibility criteria, recruitment and screening: Please provide a clear rationale for excluding older adults with cognitive impairment from your study. Contemporary guidance emphasises the importance of including this population or, where exclusion is necessary, explaining why and how this decision was made. Thank you for highlighting this important point. Our rationale for excluding older adults with an MMSE <24 was twofold: i) the need for older adults to follow instructions independently at home to deliver an effective exercise dose and ii) our concern about potential risk of injury given the online delivery of the resistance training programme. However, we would hope to see future research provide a similar intervention to older adults with cognitive impairment that incorporates additional supports to allow safe and effective exercise delivery. This could include having a trained family member/care assistant with the older person for the exercise sessions. [Under Eligibility criteria, recruitment and screening] Older adults with moderate to severe cognitive (MMSE <24) impairment will be excluded due to the need for older adults to follow instructions independently at home to deliver an effective exercise dose and our concern about potential risk of injury given the online delivery of the resistance training programme. Dietary intake: Please provide references for the technique described. Thank you. We have added references supporting the dietary intake assessment method used. [Under Dietary intake] A 24-hour dietary recall using a multiple pass technique will be conducted at each home-based assessment to establish the dietary pattern of each participant (Steinfeldt, Anand and Murayi, 2013). Discussion: Well written and the limitations of the trial are well considered. We appreciate the reviewer’s positive feedback on the Discussion section. View more View less Competing Interests No competing interests were disclosed. reply Respond Report a concern Griffin A. Peer Review Report For: Oral nutritional supplement combined with an online resistance training programme to improve physical function and nutritional status in older adults receiving home care and at risk of sarcopenia: protocol for the randomised controlled POWER trial [version 1; peer review: awaiting peer review] . 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