Elevida-Go! – a digital treatment program to improve fatigue in MS by CBT and exercise: findings from a feasibility study

Elevida-Go! – a digital treatment program to improve fatigue in MS by CBT and exercise: findings from a feasibility study | 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 Elevida-Go! – a digital treatment program to improve fatigue in MS by CBT and exercise: findings from a feasibility study Jana Pöttgen, Stephanie Lau, Björn Meyer, Christoph Heesen This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6548074/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background The cognitive behavioral therapy (CBT) based digital health application elevida has been shown to reduce Multiple Sclerosis (MS)-related fatigue, and there is substantial evidence that exercise can also alleviate fatigue. However, the combined effect of CBT and exercise remains unknown. Objective To develop a combined CBT and exercise intervention for MS fatigue and evaluate its acceptance, feasibility and preliminary effectiveness. Method To expand elevida’s exercise-related content, four new modules were developed and adapted based on qualitative feedback from persons with MS (pwMS). A single-arm feasibility study was conducted with MS patients using the resulting program, which was termed elevida-Go! . Acceptance data were gathered through standardized qualitative interviews, while initial efficacy was assessed after 4 and 6 months. Daily steps were measured by a digital step counter over the first 4 months. Further outcomes included patient-rated fatigue, information processing speed, depression, anxiety, daily activity, physical activity (PA), and quality of life (QoL). T-tests for dependent measures were computed to analyze feasibility. Results Five pwMS (n = 4 female, age M = 41 years, range 31–58) participated in the qualitative evaluation and rated the quality of the program as very good, generally meeting their expectations. All participants were satisfied with the level of help received and would recommend the program to other pwMS with fatigue, and 4 of 5 participants reported that it had improved their ability to cope with their problems. In the feasibility study (n = 24, 79% female, age M = 41 years, range 23–61) acceptance and usability of the expanded programme was confirmed as high. Pre-post analyses showed improvements in fatigue (d = 1.10, CI = .57 to 1.61), daily activity (d = .93, CI = .46 to 1.45), physical activity (d = .47, CI = .04 to .90), anxiety (d = .41, CI=-.02 to .83), and QoL (d = .57, CI = .12 to 1.01). Improvements in fatigue, daily activity, and anxiety persisted at the 6-month follow-up. Conclusion Elevida-Go! demonstrated high acceptability and usability among study participants. Preliminary efficacy data appear promising, warranting further investigation in a randomized controlled trial. Multiple Sclerosis fatigue exercise physical activity cognitive behavioural therapy fatigue training Figures Figure 1 Background Fatigue is one of the most prevalent and burdensome symptoms in persons with multiple sclerosis (pwMS), impacting patients’ well-being and quality of life (QoL), as well as their relationships with family, friends, and work life [ 1 – 3 ]. The aetiology of MS-related fatigue is likely multifactorial. According to the cognitive-behavioural model, MS-related fatigue may be triggered by disease-specific biological factors, such as (neuro)inflammation and axonal loss, as well as environmental factors, stress, other disease- or person-specific factors, whereas cognitive and behavioural processes can perpetuate fatigue [ 4 ]. Behavioral interventions such as exercise and educational programs have shown beneficial effects on MS fatigue, whereas the benefits of pharmacological treatments remain inconclusive [ 5 , 6 ]. Cognitive behavioural therapy (CBT) has been shown to be among the most effective therapies for MS fatigue [ 7 , 8 ]. CBT for MS-related fatigue generally targets fatigue-related behaviours and beliefs, including elements and techniques such as psychoeducation, goal setting, attention training, balancing activity and rest, and self-monitoring of progress. Cognitive interventions often focus on identifying and modifying negative automatic thoughts, core beliefs, or unhelpful expectations or assumptions. Behavioural interventions often include activity scheduling, goal setting, or “behavioural experiments” in which potentially helpful activities are tested. Research on exercise programs to reduce MS fatigue has shown promising results, as summarized in two systematic reviews [ 6 , 9 ]. Previous interventions have examined different exercise intensities and durations in terms of their effects on fatigue. Although endurance and mixed training appear most promising, the optimal duration and intensity levels remain uncertain [ 9 ]. Overall, treatment recommendations for balance and combined exercise were rated as moderately beneficial, and the evidence for CBT was rated as high [ 10 ]. Despite the merit of face-to-face-delivered CBT and exercise interventions, a major disadvantage relates to their time requirements (often 2 to 3 hours per week), which can constitute access barriers. Many patients with MS fatigue feel overloaded with work, family, and social commitments and may lack the time and energy for additional behavioral treatments. Moreover, there is a shortage of therapists specifically trained in MS fatigue treatments. E-health interventions may be a promising option for pwMS, reducing the need to travel and allowing patients to follow treatment at their own pace. A recent systematic review has suggested that online CBT can be beneficial for MS-related neuropsychiatric symptoms, including fatigue [ 11 ]. For example, elevida is an evidence-based digital health intervention, which has been shown to alleviate MS fatigue [ 12 ], and which has been approved by the official German regulatory body (the Federal Institute for Drugs and Medical Devices) as a digital treatment option for MS fatigue. However, to our knowledge, no studies have investigated a combined therapy concept -- whether face-to-face or e-health based -- that includes both CBT and exercise promotion. Methods The elevida-Go! project aims to build on the efficacy shown in the phase-II elevida study [ 12 ] by integrating four new modules focused on motivating and monitoring PA/exercise. Elevida Go! follows a mixed methods approach to develop a complex intervention [ 13 ] (phases 1 and 2) in collaboration between experts and those affected. From the beginning of the project, people with MS are recruited and involved as co-researchers. Study Design This project encompassed the development of elevida-Go!, which was conducted in two stages: In Step 1, we tested acceptability by gathering feedback through user interviews and updated the program by the using the evaluated feedback and ideas of participants. In Step 2, we tested the feasibility and collected preliminary data on the potential of the program to increase PA and reduce fatigue. For Step 1, five pwMS were invited to try out a preliminary version of the program and were then interviewed in depth about their experiences regarding content appropriateness, usability, and satisfaction. In step 2, we conducted an open-label, non-controlled pilot cohort study with 24 pwMS who used the full elevida-Go! program over a 12-week period. Those meeting inclusion criteria and agreeing to participate were invited to our outpatient clinic and enrolled after providing informed consent. Pre- and post-assessments were conducted before and immediately following the intervention, with an online follow-up assessment after additional 6 months. Intervention As described in detail in Pöttgen al. [ 12 ], the original elevida program was developed by a multidisciplinary team of physicians, psychologists, psychotherapists and IT experts, among others. It is based on CBT strategies and presented primarily through a ‘simulated dialogue’ format. The program includes nine modules focussing on topics such as: A CBT model of MS fatigue (e.g., role of cognitions, behaviours and emotions in fatigue), balancing activity and rest periods, attentional processes in fatigue, cognitive restructuring, coping with stress (e.g., mindfulness and relaxation techniques), sleep management, improving social support networks (see [ 12 ] for further detail). All modules include illustrations as well as audio recordings, which are used to explain techniques and facilitate skill acquisition, such as mastering relaxation exercises. Participants interact with the program by responding continuously to narrative text passages via multiple-choice options. The program then tailors subsequent information to fit individual needs (e.g., preference for elaborated explanations, additional exercises, shorter texts). For this project, four new activity-focused modules were developed to complement the previous nine modules, resulting in a 12-module program we termed elevida-Go! The four new modules cover a range of activity and exercise-related content. Specifically, the first module supports users in creating an individualized activity plan, emphasizing PA's role in managing MS fatigue. The second module focuses on an activity review, leveraging social support to maintain exercise routines, and using goal-setting techniques, such as mental contrasting, to implement activity plans and intentions. The third module addresses common exercise barriers, such as stress, fear of injury, or severe fatigue. The final module aims to help users handle activity-related setbacks by fostering self-compassion and cognitive reframing, illustrated through examples of pwMS overcoming challenges. All four modules use behaviour change techniques such as information provision, goal setting and action planning, barrier-identification and problem-solving. Self-monitoring is facilitated by the inclusion of self-report questions and additional step count technology (activity tracker). Elevida-Go! is tailored to suit minor to moderate physical disability levels and includes homework exercises. Depending on individual reading speed, each module can take between 10 and 30 minutes. Elevida-Go! also draws on behaviour change theory [ 14 , 15 ] addressing key components: capability (e.g. physical and psychological factors), motivation (e.g. self-efficacy, goals, illness beliefs) and opportunity (e.g. environmental factors, social support). Patients are instructed to access the program flexibly, with broad guidelines of engaging with it once or twice per week. The intervention time was 12 weeks in total. Both elevida and elevida-GO! were developed and are owned, operated, and distributed by GAIA, a German SME (small-to-medium enterprise) specialising in the development and research of digital therapeutic interventions. The team affiliated with INIMS supported and collaborated in the research and development of these programmes; however, the IP and ownership remain with GAIA. Outcomes In Step 1 and 2 demographic data (age, sex, family status, education) and disease specific data (disease duration, disease course, EDSS) were collected before starting the program. The Fatigue Scale for Motor and cognition (FSMC, [ 16 ]) was administered to measure fatigue as an inclusion criterium (FSMC sum score cut-off > 42). In Step 1, the aim was to gather feedback on the usability and personal satisfaction of elevida Go! and to refine the program development based on participants improvement suggestions. Participants were interviewed via telephone using a standardized, self-developed open questionnaire about their experiences regarding content appropriateness, usability, and satisfaction. Their responses were recorded in writing. Additionally, participants were asked to complete an adapted version of the German Patient Satisfaction Questionnaire (ZUF-8) [ 17 ] supplemented with program-specific questions to assess perceived usability and satisfaction. Step 2 focused on assessing the feasibility of the study process and collecting preliminary data on the program’s potential to increase PA and reduce fatigue. Fatigue was assessed using the Chalder Fatigue Scale (CFS, [ 18 ]) to facilitate descriptive comparisons with the previous elevida trial. Additional patient-reported outcomes included depression and anxiety, measured by the Hospital Anxiety and Depression Scale (HADS, [ 19 ]); health-related quality of life, quantified by the Hamburg Quality of Life Questionnaire for MS (HAQUAMS, [ 20 ]); activities of daily living, assessed by the Frenchay Activity Index (FAI, [ 21 ]); and illness perception, measured by the Brief Illness Perception Questionnaire (IPQ, [ 22 ]). General cognitive status was screened with the Symbol Digit Modalities Test (SDMT, [ 23 ]). The Godin Leisure Time Exercise Questionnaire was used as a self-report measure of PA [ 24 ]. In addition, PA in the real-world setting was monitored by a smart watch fitness tracker over the first 16 weeks. Each month during the intervention period, participants were asked another 4 activity-related questions: 1–3) How often per week do you engage in a) high-intensity exercise, b) moderate exercise, c) low-intensity exercise, and 4) How often do you engage in activities that cause sweating? (answer options = a) 4 to 7 times/week, b) 2 to 3 times/week, c) 0 to 1 time/week. Measures were assessed at baseline (V0 before starting the intervention), at post intervention time point (V1) and one year after baseline (V2). Recruitment Both for Step 1 (n = 5), and Step 2 (n = 24), participants were recruited from the MS Day Hospital database of the UMC Hamburg Eppendorf and invited to participate by telephone or email. Eligibility screening was based on fatigue scores from the MS fatigue subscale of the HAQUAMS [ 20 ], as noted in the database. Patients scoring ≥ 2 were contacted by telephone. Detailed information about the research project was provided either by phone or in person. Inclusion criteria Participants were required to have an MS diagnosis according to McDonald criteria [ 25 ], any disease course, Expanded Disability Status Scale (EDSS, [ 26 ] < 4.5; FSMC total fatigue score ≥ 43; ability to read texts and to answer questionnaires via internet; internet equipment at home (PC/tablet with internet access), ability to follow a digital intervention, and willingness to participate. Exclusion criteria included an unclear diagnosis; neuromyelitis optica; and severe psychiatric disorders (e.g., psychotic disorders, although depressive disorders were permitted). Statistical and descriptive analyses Each Step 1 interview was conducted by telephone, with participant responses recorded in writing and summarized by the interviewer. Reports were analysed by an expert psychologist (J. Pöttgen) at the INIMS under the guidance of C. Heesen; representative statements were categorized. Baseline analyses describe demographic and clinical data, as well as all other study specific measures (step1 & step 2). The longitudinal analyses (step 2) focussed on differences between measures obtained at pre-training (baseline), post-training (V1), and follow-up (V2) one year after inclusion. Effect sizes (Cohen’s d) were calculated for paired values. Missing values (step 2) of daily step data or values below 200 steps/day (up to 2 missing days per week) were imputed using the weekly mean. Missing weeks (up to 3 weeks in total) were imputed by the mean of the other weeks. Results Recruitment took place (Step 1) in May 2022 and (Step 2) from March to June 2023 for the feasibility study. Overall, five patients were included in the qualitative part of step 1, consisting of the interviews (n = 5; four women and one man); and for step 2, n = 24 patients were included (nineteen women and five men). Median age was 41 in both groups with slight differences in the ranges. Participants in step 2 were highly educated (median years of education = 15 years), the disability measured by the EDSS was low in step 2 (median = 1.3), moderate in step 1 with a wide range (1-6.5). Table 1: Demography of pwMS Step 1 Step 2 N 5 24 Age (median in years, (range)) 41 (31-58) 41 (23-61) Sex (female, (%)) 4 (80) 19 (79) Family status (n, %) singled Married Divorced 2 (40) 2 (40) 1 (20) 6 (25) 9 (38) 6 (25) 3 (7) Education (median in years, (range)) n.d. 15 (11-18) Working status Full day Half day Homemaker Workless disabled 12 (50) 6 (25) 1 (4) 1 (4) 2 (8) 12 (50) 6 (25) 1 (4) 1 (4) 2 (8) Impairment (EDSS) Median (range) 2.5 (1-6.5) 1.3 (0-3) Last relapse (n, %) I never had relapses In the last 4 weeks In the last 6 weeks In the last year More than a year ago 1 (20) 0 3 (60) 0 1 (20) 5 (21) 3 (13) 5 (21) 5 (20) 6 (25) n.d.=no data, SD=Standard deviation, PDDS=Patient-Determined Disease Steps Findings of the feasibiitly (step 1) study Step 1 We tested the acceptance of the new program in n=5 MS patients. For details of demographic data, see table 1. Quantitative analysis of the program quality indicated high acceptance (see table 2). All participants rated the language and voice guiding the exercises and meditation tasks very positively. Specific program aspects, including illustrations, helpfulness, engagement, support, and overall pleasantness were also rated highly. None of the participants reported feeling “indoctrinated”, the content per page was considered manageable, with explanations, summaries, and worksheets all deemed to be helpful. All participants would recommend the program to other pwMS experiencing fatigue. In total, the program received high scores for quality, alignment with expectations and needs, satisfaction, and its ability to reduce fatigue. Table 2: Perceived benefits of the program in the step 1 study Question n (%) bad not so good good excellent How would you rate the quality of “elevida-Go!”? 3/5 2/5 Not at all No Yes completely yes Was the treatment you have received in line with your expectations? 4/5 1/5 Did “elevida-Go!” meet your needs? 1/5 1/5 4/5 Would you recommend “elevida-Go!” to a friend if he/she needed suffer from fatigue? 5/5 Are you satisfied with the level of help you received from “elevida-Go!”? 2/5 3/5 Did “elevida-Go!” helped you to deal with your problems more appropriately? 1 (20) 1 (20) 3 (60) Are you satisfied with “elevida-Go!” in total? 2 (40) 3 (60) Would you use “elevida-Go!” again? 2 (40) 3 (60) I totally disagree I disagree I agree I totally agree The language in the program is generally easy to understand. 5 (100) I liked the illustrations. 1 (20) 3 (60) 1 (20) The voice of the audio artist was pleasant. 5 (100) The content was helpful and interesting. 1 (20) 2 (40) 2 (40) I believe that elevida Go! will be very helpful for many people with MS fatigue. 2 (40) 3 (60) The way elevida Go! “spoke” to me was friendly, supportive and pleasant. 1 (20) 4 (80) The program seemed didactic or know-it-all. 4 (80) 1 (20) The texts per page were too long. 2 (40) 2 (40) 1 (20) The references and explanations of scientific studies were helpful. 1 (20) 4 (80) The summaries and worksheets are a helpful addition to the program. 3 (60) 2 (40) I would recommend the program to someone suffering from MS fatigue. 5 (100) The program was perceived as being mainly in line with personal expectations. One person did not feel that her personal needs were met by the program. All participants would recommend elevida-Go! to other pwMS with fatigue. All participants were satisfied with the level of help they received from the program. Four of five participants reported improved coping ability with their problems. Overall program satisfaction was very high, and all participants reported they would use it again. Respondents were also asked to elaborate on their subjective impressions of elevida-Go! (qualitative impressions) displayed in table 3. Responses were generally consistent with the quantitative findings and confirmed the impression that patients were satisfied with the program. Table 3: categories of qualitative findings in step 1 study (n=5) Domain patient comments positive exercise related feedback Good introduction of different types of exercises Understandable indications of positive effects of sport New impulses to move Good introduction of physical exercises Provided exercises are easy to implement in everyday life positive program related feedback Surprising versatility of the program in total Physical activities and meditation work well together App is easy to use on tablet, computer or smartphone Clear and easily understandable language Inspirating daily SMS with thoughts for the day Nice photos and illustrations Pleasant voice of the speaker Appealing relaxation exercises The system was explained well The audios are good Provided case studies were helpful positive motivational feedback The program motivates me to workout at home The letters to the friend are good/engaging The explanations of the meaning of exercising were motivating The program encourages reflection I felt understood negative exercise-related feedback Options for people who already do a lot of sports were missing The program is frustrating for wheelchair users negative program-elated feedback The links for scientific sources in the text were too tedious You have to sit down and actively listen, which can be difficult with fatigue Modules are too long negative motivational feedback too much journaling required general tips Providing a separate list for literature references of studies Activity-based alternatives would be good Providing links to exercise programmes for people on low incomes Results of the qualitative analyses were used to slightly adapt relevant text passages of the program. Findings of the pilot cohort study (step 2) In step 2, we collected data to estimate the uncontrolled effects of elevida-Go! in improving fatigue and other relevant variables. We recruited 24 participants; their demographic data are displayed in table 1. Preliminary data of improvements in neuropsychiatric measures are reported in table 4. Data from one person was lost at the post assessment time-point. We observed improvements in fatigue, daily activity, anxiety, self-reported exercising, and quality of life (subscales fatigue, cognition, upper limbs, mood and total score). No improvements were observed on measures of cognition, depression, perceived illness, and QoL subscales communication and lower limbs. Table 4: Data of the baseline and post-assessments in the pilot study (significant effects 0<.05 are in bold) Baseline mean Post Mean (n=23) Cohen’s d (CI) Follow up mean (n=21) Cohen’s d (CI) CFS 22.0 (5.8) 13.0 (6.6) 1.10 (.57 to 1.61) 14.4 (4.6) 1.03 (.49 to 1.55) FAI 32.8 (7.7) 39.3 (7.5) .96 (.46 to 1.45) 36.1 (7.5) .62 (.14 to 1.08) SDMT 54.1 (8.7) 54.7 (9.7) .06 (-.54 to .41) HADS Depr. 7.0 (4.5) 6.0 (3.2) .26 (-.16 to .67) 6.2 (3.1) .33 (-.12 to .76) HADS Anxiety 9.1 (4.3) 8.0 (3.3) .41 (-.02 to .83) 7.7 (3.3) .46 (.02 to .92) Godin 34.2 (20.3) 45.0 (24.3) .47 (.04 to .90) 39.5 (20.1) .40 (-.84 to .05) IPQ 45.8 (7.8) 45.4 (9.4) .05 (-.36 to .46) HAQUAMS Fatigue 13.6 (3.3) 12.2 (3.9) .39 (-.41 to .81) HAQUAMS Cognition 13.1 (3.9) 11.6 (4.1) .46 (.03 to .89) HAQUAMS Lower limbs 7.5 (3.2) 7.3 (3.8) .10 (-.31 to .51) HAQUAMS Upper limbs 7.9 (3.4) 7.2 (3.4) .43 (-.01 to .85) HAQUAMS Communication 14.3 (4.2) 14.0 (4.2) .11 (-.30 to .52) HAQUAMS Mood 14.0 (3.7) 12.3 (4.1) .48 (.42 to .91) HAQUAMS total 70.3 (15.6) 64.5 (16.8) .57 (.13 to .98) Follow up-data (1 year after pre assessment, median 363 days, range(309-403)) in n=21 pwMS suggested long-term beneficial effects of elevida-Go! on fatigue (CFS), daily activity (FAI) and anxiety (HADS). The measured step data collected by a smartwatch during the intervention and reported by participants were evaluated based on the steps per week over the first 16 weeks (see figure 1). Daily steps increased slightly between the first and the 9 th week; however, daily steps then appeared to decrease slightly for the next seven weeks. Self-reported exercise data (table 6) show a slight increase from month 1 to month 2 for moderate and low-intensity exercises, with subsequent slight reductions. For high-intensity exercise, the number decreased slightly from month 1 to month 2, and also to month 3. Also, intensive exercise causing sweating decreased over time, except for an increase for answer b) (2 to 3 times a week). Table 6: Reported active training sessions month 1 (n=22) month 2 (n=23) month 3 (n=20) 1-3) How often do you do per week (mean (range)) a) effortful exercises b) moderate exercises c) effortless exercises? 1.1 (0-4) 3.0 (0-7) 4.4 (0-7) 1.0 (0-4) 3.8 (0-14) 5.0 (1-14) 0.9 (0-4) 2.5 (0-14) 4.5 (0-21) 4) How often do you do sports that make you sweat? (n (%)) a) 4 to 7 times a week b) 2 to 3 times a week c) 0 to 1 time a week 6 (28) 8 (36) 8 (36) 7 (30) 8 (35) 8 (35) 4 (20) 11 (55) 5 (25) Program usage All 24 participants started with the elevida-Go! Program; the median of numbers of finished modules was 7 (54%). Whereas 7 (29%) participants finished all 13 modules, one participant only started the first module but did not finish it. Fifteen (63%) participants finished 7 or more modules, and 5 (21%) persons less than 4. The mean amount of time participants engaged in the intervention was 5.0 hours (range from 0.2 to 9.7 hours). Discussion This study reports on the further development of a regulated digital health application (elevida) for pwMS. In addition to the original nine modules, four new modules focused on PA were developed and integrated into the existing elevida program, and the resulting integrated program was termed elevida-Go!. These new modules were embedded in the CBT program elevida, which targets fatigue among pwMS. The beneficial effects of CBT on MS fatigue have been summarized in recent reviews [ 6 , 8 ]. The positive influence of PA on MS-associated fatigue has rarely been studied as a primary treatment goal in exercise studies; a systematic review [ 9 ] indicates efficacy based on studies investigating fatigue as a secondary outcome, whereas a larger 16-week randomised controlled trial (RCT) with aerobic training in pwMS with severe fatigue did not find beneficial effects [ 27 ]. To our knowledge, a combined training program consisting of a CBT-based program in combination with intervention elements to promote exercise and PA to treat MS fatigue has not yet been developed in digital or personally delivered format. Our pilot study revealed generally positive feedback regarding the program, and prospective data suggested beneficial effects on fatigue and other outcomes. Initially, a small group of pwMS were asked to rate their satisfaction and acceptance of the first prototype of elevida-Go!. Suggestions for improvement and recommendations from the participants were noted and used for program adaptations and fine-tuning. Overall, participants reported a positive impression of the program’s quality, satisfaction with its content, and a perceived improvement in fatigue. All participants found the program easy to understand and would recommend it to other people with MS (pwMS) who experience MS-related fatigue. The program’s motivational aspect, encouraging participants to become more active and follow an exercise plan, was highlighted. However, a few participants noted that some modules felt lengthy and expressed a desire for more suggestions tailored to individuals with greater disabilities. The pilot study suggested robust improvements on a variety of key outcomes, including fatigue, daily activity, anxiety, self-reported exercising, and quality of life. The pre-post effect sizes were in the medium and even large range for several of these variables, although the absence of a control group prohibits clear causal conclusions. Nevertheless, in the context of positive effects of PA on fatigue observed in previous studies [ 9 ], these pilot results appear promising and suggest that adding PA-focused modules may have enhanced the already robust effect of elevida on fatigue reductions over time. Our large trial investigating elevida was our first attempt to treat MS fatigue via a digital intervention, and it showed positive effects on other outcomes as well, including anxiety, daily activity and quality of life [ 12 ]. Within this pilot study using elevida-Go! the positive effect on fatigue is even higher (1.10 (.57 to 1.61) vs. 0.53 (− 4.32 to 1.16). In addition, we were able to replicate the improvements in anxiety, quality of life, and daily activity. This study also showed improvements in self-rated activity behaviour. The beneficial effects of PA and exercise on MS fatigue have been well documented recent years, although several studies also suggest that pwMS tend to do exercise less than healthy individuals [ 28 ]. Motivating pwMS to increase their PA levels represents a major challenge for neurologists, physiotherapists, psychotherapists and other pwMS health care providers. The maintenance of exercise behaviour change is a problem in MS, but also in the general population [ 15 ]. Current treatment options in Germany are usually limited to periodic inpatient rehabilitation treatments. Researchers have highlighted the need to include theory-based behavioral approaches for long-term behavior change. In a randomized controlled pilot trial of a community-delivered exercise program combined with behavior change techniques in people with MS (pwMS), Hayes et al. [ 29 ] could show significant effects on physical activity in pwMS after 10 and 36 weeks. Digital health applications can help bridge this gap by offering easily accessible information on the importance of exercise for pwMS and by conveying motivational and therapeutic techniques that facilitate relevant behavior change. Based on the theories of behavior change, strategies such as information provision, goal setting, barrier recognition, self-monitoring, and social support are essential therapeutic components. Cognitive behavioral therapy can incorporate these and other elements to support the adoption of appropriate PA habits. Both elevida and elevida-Go! are grounded in a broad range of behavior change techniques and CBT methods, although future research is needed to disentangle the pathways and mechanisms through which beneficial effects unfold. In our pilot trial we could show the beneficial long-term effect (over 1 year) of the CBT-based eHealth intervention elevida-Go! on fatigue, daily activity and anxiety. We lost only 3 (13%) pwMs at the follow up timepoint at V2 (1 year after baseline). This low drop-out rate underlines participants’ acceptance and satisfaction with elevida-Go!. Fewer than half of the participants (29%) completed all 13 modules, the average number completed was 7 (54%). Compared to a recent review studying the adherence rate for eHealth interventions to treat depression, the adherence rate in our pilot trial was slightly below the mean level of adherence in other studies [ 30 ]. However, studies have found many factors influencing adherence, including age, recruitment sourced (internet vs. in care centers), and gender [ 31 ]. In our trial, more than half of participants (63%) completed at least 7 of 13 modules. Unfortunately, we did not assess the reasons for attrition by interviewing the participants. Regarding the drop-out rate, we lost only one person in the primary study trial at the post assessment timepoint. Our data from a small sample of 24 pwMS provides preliminary evidence of the positive effects of elevida-Go!. In addition to fatigue reduction, participants also reported some improvements in everyday activity, anxiety, and quality of life, along with increases in self-reported PA. Comparable with findings in the large elevida RCT [ 12 ] we also did not find an impact on depression and cognitive complaints. Notably, the beneficial effects appeared to remain stable over a period of 1 year, although self-perceived bodily activity decreased somewhat over time. In addition, the number of steps did not change over the intervention period. Unfortunately, no baseline data was collected for step count, limiting conclusions on this parameter. Several limitations need to be noted. As this feasibility cohort was small and the study lacked a control group, conclusions on causality are not possible. In addition, the sample consisted of pwMS who were recruited only from the UKE’s MS day clinic in Hamburg, which may have introduced selection bias, as participants were likely already inclined to be more active and most of participants had low disability levels. The adherence rate was lower than other eHealth trials, likely due to the high number of modules (14). Furthermore, no baseline assessment was available for some outcomes, which restricts the scope of our analysis. Conclusions In conclusion the results of elevida-Go! show potential to enhance PA levels among pwMS, thereby potentially reducing MS-related fatigue. In addition to alleviating fatigue, increased PA may interact with other MS symptom domains and could potentially influence disease-related inflammatory and neurodegenerative processes. These encouraging findings suggest that larger and more controlled trials are warranted to confirm and extend these effects. Abbreviations CBT Cognitive Behavioral Therapy CFS Chalder Fatigue Scale CI Confidence interval d Cohen’s effect size EDSS Expanded Disability and Status Scale FAI Frenchay Activity Index FSMC Fatigue Sclae for Motor and Cognition GAIA Digital Therapeutics Business Company HADS Hospital Anxiety and Depression Scale HAQUAMS Hamburg Quality of Life Questionnaire for Multiple Sclerosis INIMS Institute of Neuroimmunology and Multiple Sclerosis IPQ Illness Perception Questionnaire MS Multiple Sclerosis n.d. no data PA Physical Activity PDDS Patient Determined Disease Steps PwMS Person with Multiple Sclerosis QoL Quality of Life RCT Randomized Controlled Trial SD Standard Deviation SDMT Symbol Digit and Modalities Test SME Smal-to- medium enterprice UKE University Medical Center Hamburg Eppendorf UMC University Medical Center V Visit ZUF-8 German Patient Satisfaction Questionnaire Declarations Ethics approval The study has been approved by the Ethics Committee of the Hamburg Chamber of Physicians (2021-100717-BO-ff) and written informed consent was obtained from all participants. This study adhered to the Declaration of Helsinki (2013). Consent for publication Not applicable. Availability of data and materials All data/materials are available, please contact the corresponding author. Competing Interests The authors declare no competing interests. Funding This research was supported by the BMS Investigator Sponsored Research Program. Authors’ contributions Jana Pöttgen: Conceptualisation; Funding acquisition; Data curation; Formal analysis; Investigation; Methodology; Project administration; Visualisation; Writing – original draft. Stephanie Lau: Conceptualisation; Methodology; Resources; Supervision; Writing – review & editing. Björn Meyer: Conceptualisation; Methodology; Resources; Writing – review & editing. Christoph Heesen: Conceptualisation; Funding acquisition; Investigation; Methodology; Project administration; Resources; Supervision; Writing – review & editing. Acknowledgements We would like to thank Susan Seddiq Zai for her contribution to the logistics of the trial, data acquisition, quality control, and data management. References Le HH , Ken-Opurum J , LaPrade A , Maculaitis MC , Sheehan JJ. Exploring humanistic burden of fatigue in adults with multiple sclerosis: an analysis of US National Health and Wellness Survey data. BMC neurology 2024; 24: 51 Oliva Ramirez A , Keenan A , Kalau O , Worthington E , Cohen L , Singh S. Prevalence and burden of multiple sclerosis-related fatigue: a systematic literature review. BMC neurology 2021; 21: 468 Rooney S , Wood L , Moffat F , Paul L. Prevalence of fatigue and its association with clinical features in progressive and non-progressive forms of Multiple Sclerosis. Multiple sclerosis and related disorders 2019; 28: 276–82 van Kessel K , Moss-Morris R. Understanding multiple sclerosis fatigue: a synthesis of biological and psychological factors. Journal of psychosomatic research 2006; 61: 583–5 Asano M , Finlayson ML. Meta-analysis of three different types of fatigue management interventions for people with multiple sclerosis: exercise, education, and medication. Multiple sclerosis international 2014; 2014: 798285 Moss-Morris R , Harrison AM , Safari R , et al. Which behavioural and exercise interventions targeting fatigue show the most promise in multiple sclerosis? A systematic review with narrative synthesis and meta-analysis. Behaviour research and therapy 2021; 137: 103464 Wendebourg MJ , Heesen C , Finlayson M , Meyer B , Pöttgen J , Köpke S. Patient education for people with multiple sclerosis-associated fatigue: A systematic review. PLoS ONE 2017; 12: e0173025 Wendebourg MJ , Poettgen J , Finlayson M , et al. Education for fatigue management in people with multiple sclerosis: Systematic review and meta-analysis. European journal of neurology 2024: e16452 Heine M , van de Port I , Rietberg MB , van Wegen EEH , Kwakkel G. Exercise therapy for fatigue in multiple sclerosis. The Cochrane database of systematic reviews 2015: CD009956 Harrison AM , Safari R , Mercer T , et al. Which exercise and behavioural interventions show most promise for treating fatigue in multiple sclerosis? A network meta-analysis. Multiple sclerosis (Houndmills, Basingstoke, England) 2021; 27: 1657–78 Heesen C , Lühmann D. Reply: Mobile health interventions in multiple sclerosis: A systematic review. Multiple sclerosis (Houndmills, Basingstoke, England) 2024; 30: 619–20 Pöttgen J , Moss-Morris R , Wendebourg J-M , et al. Randomised controlled trial of a self-guided online fatigue intervention in multiple sclerosis. Journal of neurology, neurosurgery, and psychiatry 2018; 89: 970–6 Skivington K , Matthews L , Simpson SA , et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ (Clinical research ed.) 2021; 374: n2061 Casey B , Coote S , Shirazipour C , et al. Modifiable Psychosocial Constructs Associated With Physical Activity Participation in People With Multiple Sclerosis: A Systematic Review and Meta-Analysis. Archives of physical medicine and rehabilitation 2017; 98: 1453–75 Michie S , van Stralen MM , West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implementation science : IS 2011; 6: 42 Penner IK , Raselli C , Stöcklin M , Opwis K , Kappos L , Calabrese P. The Fatigue Scale for Motor and Cognitive Functions (FSMC): validation of a new instrument to assess multiple sclerosis-related fatigue. Multiple sclerosis (Houndmills, Basingstoke, England) 2009; 15: 1509–17 Schmidt J , Lamprecht F , Wittmann WW. Zufriedenheit mit der stationären Versorgung. Entwicklung eines Fragebogens und erste Validitätsuntersuchungen. Psychotherapie, Psychosomatik, medizinische Psychologie 1989; 39: 248–55 Chilcot J , Norton S , Kelly ME , Moss-Morris R. The Chalder Fatigue Questionnaire is a valid and reliable measure of perceived fatigue severity in multiple sclerosis. Multiple sclerosis (Houndmills, Basingstoke, England) 2016; 22: 677–84 Herrmann C. International experiences with the Hospital Anxiety and Depression Scale-A review of validation data and clinical results. Journal of psychosomatic research 1997; 42: 17–41 Schäffler N , Schönberg P , Stephan J , Stellmann J-P , Gold SM , Heesen C. Comparison of patient-reported outcome measures in multiple sclerosis. Acta neurologica Scandinavica 2013; 128: 114–21 Turnbull JC , Kersten P , Habib M , McLellan L , Mullee MA , George S. Validation of the Frenchay Activities Index in a general population aged 16 years and older. Archives of physical medicine and rehabilitation 2000; 81: 1034–8 Broadbent E , Petrie KJ , Main J , Weinman J. The brief illness perception questionnaire. Journal of psychosomatic research 2006; 60: 631–7 Benedict RH , Deluca J , Phillips G , LaRocca N , Hudson LD , Rudick R. Validity of the Symbol Digit Modalities Test as a cognition performance outcome measure for multiple sclerosis. Multiple sclerosis (Houndmills, Basingstoke, England) 2017; 23: 721–33 Motl RW , Bollaert RE , Sandroff BM. Validation of the Godin Leisure-Time Exercise Questionnaire classification coding system using accelerometry in multiple sclerosis. Rehabilitation psychology 2018; 63: 77–82 Thompson AJ , Banwell BL , Barkhof F , et al. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. The Lancet. Neurology 2018; 17: 162–73 Kurtzke JF. On the origin of EDSS. Multiple sclerosis and related disorders 2015; 4: 95–103 Heine M , Verschuren O , Hoogervorst EL , et al. Does aerobic training alleviate fatigue and improve societal participation in patients with multiple sclerosis? A randomized controlled trial. Multiple sclerosis (Houndmills, Basingstoke, England) 2017; 23: 1517–26 Motl RW , Sandroff BM , Kwakkel G , et al. Exercise in patients with multiple sclerosis. The Lancet. Neurology 2017; 16: 848–56 Hayes S , Uszynski MK , Motl RW , et al. Randomised controlled pilot trial of an exercise plus behaviour change intervention in people with multiple sclerosis: the Step it Up study. BMJ open 2017; 7: e016336 Forbes A , Keleher MR , Venditto M , DiBiasi F. Assessing Patient Adherence to and Engagement With Digital Interventions for Depression in Clinical Trials: Systematic Literature Review. Journal of Medical Internet Research 2023; 25: e43727 Fuhr K , Schröder J , Berger T , et al. The association between adherence and outcome in an Internet intervention for depression. Journal of affective disorders 2018; 229: 443–9 Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted 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. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6548074","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":457709342,"identity":"ceed6b3f-d331-45bd-962f-3ad6783ab08a","order_by":0,"name":"Jana Pöttgen","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA0klEQVRIiWNgGAWjYBACxgY4k/kAiIMkgFdLggGQYEsgTgsEgLXwGBCnhbmB9+CDjz/+2PVL93yTnFHBINtP2GF8yYYzEgySZ845u01ywxkG45mErGFs4DGT5gFqMbiRu03yYRtD4oYDxGj5A9RifyPnmeTDfwyJ+4nSAvS+nYFEDpvkxgagLQT90gz0S0+acYLEjTRjyxnHJIxnELLFsL334IMfNnL2/DOSH97sqbGR7W8gpKWZB0wnQhVKEHIWA4M8A0SLPWGlo2AUjIJRMGIBAC/GQI7whMI8AAAAAElFTkSuQmCC","orcid":"","institution":"Institute of Neuroimmunology and Multiple Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Hamburg","correspondingAuthor":true,"prefix":"","firstName":"Jana","middleName":"","lastName":"Pöttgen","suffix":""},{"id":457709345,"identity":"0c3ea189-e771-4a4f-b09d-b6f1c33c777c","order_by":1,"name":"Stephanie Lau","email":"","orcid":"","institution":"Institute of Neuroimmunology and Multiple Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Hamburg","correspondingAuthor":false,"prefix":"","firstName":"Stephanie","middleName":"","lastName":"Lau","suffix":""},{"id":457709346,"identity":"40ca5c6a-6aa1-4d23-aa69-869aa430f456","order_by":2,"name":"Björn Meyer","email":"","orcid":"","institution":"GAIA Group","correspondingAuthor":false,"prefix":"","firstName":"Björn","middleName":"","lastName":"Meyer","suffix":""},{"id":457709348,"identity":"4e66c278-f4ac-4417-b244-29b488f3e910","order_by":3,"name":"Christoph Heesen","email":"","orcid":"","institution":"Institute of Neuroimmunology and Multiple Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Hamburg","correspondingAuthor":false,"prefix":"","firstName":"Christoph","middleName":"","lastName":"Heesen","suffix":""}],"badges":[],"createdAt":"2025-04-28 12:53:27","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6548074/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6548074/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":83032449,"identity":"9411b115-3413-4949-a1cc-a41397d6d35a","added_by":"auto","created_at":"2025-05-19 09:21:20","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":292195,"visible":true,"origin":"","legend":"\u003cp\u003eDaily steps during the intervention (n=23)\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-6548074/v1/cace44eaaf3f25426cd9b1cd.jpeg"},{"id":84388925,"identity":"c5a41f7a-6b4e-4bcc-977a-c9f49185120a","added_by":"auto","created_at":"2025-06-11 10:53:34","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1322538,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6548074/v1/06bcd26f-587f-4999-b1c5-25fe1d588ab0.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Elevida-Go! – a digital treatment program to improve fatigue in MS by CBT and exercise: findings from a feasibility study","fulltext":[{"header":"Background","content":"\u003cp\u003eFatigue is one of the most prevalent and burdensome symptoms in persons with multiple sclerosis (pwMS), impacting patients\u0026rsquo; well-being and quality of life (QoL), as well as their relationships with family, friends, and work life [\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. The aetiology of MS-related fatigue is likely multifactorial. According to the cognitive-behavioural model, MS-related fatigue may be triggered by disease-specific biological factors, such as (neuro)inflammation and axonal loss, as well as environmental factors, stress, other disease- or person-specific factors, whereas cognitive and behavioural processes can perpetuate fatigue [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Behavioral interventions such as exercise and educational programs have shown beneficial effects on MS fatigue, whereas the benefits of pharmacological treatments remain inconclusive [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Cognitive behavioural therapy (CBT) has been shown to be among the most effective therapies for MS fatigue [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. CBT for MS-related fatigue generally targets fatigue-related behaviours and beliefs, including elements and techniques such as psychoeducation, goal setting, attention training, balancing activity and rest, and self-monitoring of progress. Cognitive interventions often focus on identifying and modifying negative automatic thoughts, core beliefs, or unhelpful expectations or assumptions. Behavioural interventions often include activity scheduling, goal setting, or \u0026ldquo;behavioural experiments\u0026rdquo; in which potentially helpful activities are tested.\u003c/p\u003e \u003cp\u003eResearch on exercise programs to reduce MS fatigue has shown promising results, as summarized in two systematic reviews [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Previous interventions have examined different exercise intensities and durations in terms of their effects on fatigue. Although endurance and mixed training appear most promising, the optimal duration and intensity levels remain uncertain [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Overall, treatment recommendations for balance and combined exercise were rated as moderately beneficial, and the evidence for CBT was rated as high [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eDespite the merit of face-to-face-delivered CBT and exercise interventions, a major disadvantage relates to their time requirements (often 2 to 3 hours per week), which can constitute access barriers. Many patients with MS fatigue feel overloaded with work, family, and social commitments and may lack the time and energy for additional behavioral treatments. Moreover, there is a shortage of therapists specifically trained in MS fatigue treatments.\u003c/p\u003e \u003cp\u003eE-health interventions may be a promising option for pwMS, reducing the need to travel and allowing patients to follow treatment at their own pace. A recent systematic review has suggested that online CBT can be beneficial for MS-related neuropsychiatric symptoms, including fatigue [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. For example, \u003cem\u003eelevida\u003c/em\u003e is an evidence-based digital health intervention, which has been shown to alleviate MS fatigue [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e], and which has been approved by the official German regulatory body (the Federal Institute for Drugs and Medical Devices) as a digital treatment option for MS fatigue. However, to our knowledge, no studies have investigated a combined therapy concept -- whether face-to-face or e-health based -- that includes both CBT and exercise promotion.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eThe elevida-Go! project aims to build on the efficacy shown in the phase-II elevida study [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e] by integrating four new modules focused on motivating and monitoring PA/exercise.\u003c/p\u003e \u003cp\u003eElevida Go! follows a mixed methods approach to develop a complex intervention [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e] (phases 1 and 2) in collaboration between experts and those affected. From the beginning of the project, people with MS are recruited and involved as co-researchers.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Design\u003c/h2\u003e \u003cp\u003eThis project encompassed the development of elevida-Go!, which was conducted in two stages: In Step 1, we tested acceptability by gathering feedback through user interviews and updated the program by the using the evaluated feedback and ideas of participants. In Step 2, we tested the feasibility and collected preliminary data on the potential of the program to increase PA and reduce fatigue. For Step 1, five pwMS were invited to try out a preliminary version of the program and were then interviewed in depth about their experiences regarding content appropriateness, usability, and satisfaction. In step 2, we conducted an open-label, non-controlled pilot cohort study with 24 pwMS who used the full elevida-Go! program over a 12-week period. Those meeting inclusion criteria and agreeing to participate were invited to our outpatient clinic and enrolled after providing informed consent. Pre- and post-assessments were conducted before and immediately following the intervention, with an online follow-up assessment after additional 6 months.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eIntervention\u003c/h3\u003e\n\u003cp\u003eAs described in detail in P\u0026ouml;ttgen al. [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e], the original elevida program was developed by a multidisciplinary team of physicians, psychologists, psychotherapists and IT experts, among others. It is based on CBT strategies and presented primarily through a \u0026lsquo;simulated dialogue\u0026rsquo; format. The program includes nine modules focussing on topics such as: A CBT model of MS fatigue (e.g., role of cognitions, behaviours and emotions in fatigue), balancing activity and rest periods, attentional processes in fatigue, cognitive restructuring, coping with stress (e.g., mindfulness and relaxation techniques), sleep management, improving social support networks (see [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e] for further detail). All modules include illustrations as well as audio recordings, which are used to explain techniques and facilitate skill acquisition, such as mastering relaxation exercises. Participants interact with the program by responding continuously to narrative text passages via multiple-choice options. The program then tailors subsequent information to fit individual needs (e.g., preference for elaborated explanations, additional exercises, shorter texts). For this project, four new activity-focused modules were developed to complement the previous nine modules, resulting in a 12-module program we termed \u003cem\u003eelevida-Go!\u003c/em\u003e\u003c/p\u003e \u003cp\u003eThe four new modules cover a range of activity and exercise-related content. Specifically, the first module supports users in creating an individualized activity plan, emphasizing PA's role in managing MS fatigue. The second module focuses on an activity review, leveraging social support to maintain exercise routines, and using goal-setting techniques, such as mental contrasting, to implement activity plans and intentions. The third module addresses common exercise barriers, such as stress, fear of injury, or severe fatigue. The final module aims to help users handle activity-related setbacks by fostering self-compassion and cognitive reframing, illustrated through examples of pwMS overcoming challenges. All four modules use behaviour change techniques such as information provision, goal setting and action planning, barrier-identification and problem-solving. Self-monitoring is facilitated by the inclusion of self-report questions and additional step count technology (activity tracker). Elevida-Go! is tailored to suit minor to moderate physical disability levels and includes homework exercises. Depending on individual reading speed, each module can take between 10 and 30 minutes. Elevida-Go! also draws on behaviour change theory [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e] addressing key components: capability (e.g. physical and psychological factors), motivation (e.g. self-efficacy, goals, illness beliefs) and opportunity (e.g. environmental factors, social support). Patients are instructed to access the program flexibly, with broad guidelines of engaging with it once or twice per week. The intervention time was 12 weeks in total. Both elevida and elevida-GO! were developed and are owned, operated, and distributed by GAIA, a German SME (small-to-medium enterprise) specialising in the development and research of digital therapeutic interventions. The team affiliated with INIMS supported and collaborated in the research and development of these programmes; however, the IP and ownership remain with GAIA.\u003c/p\u003e\n\u003ch3\u003eOutcomes\u003c/h3\u003e\n\u003cp\u003eIn Step 1 and 2 demographic data (age, sex, family status, education) and disease specific data (disease duration, disease course, EDSS) were collected before starting the program. The Fatigue Scale for Motor and cognition (FSMC, [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]) was administered to measure fatigue as an inclusion criterium (FSMC sum score cut-off \u0026gt;\u0026thinsp;42).\u003c/p\u003e \u003cp\u003eIn Step 1, the aim was to gather feedback on the usability and personal satisfaction of elevida Go! and to refine the program development based on participants improvement suggestions. Participants were interviewed via telephone using a standardized, self-developed open questionnaire about their experiences regarding content appropriateness, usability, and satisfaction. Their responses were recorded in writing. Additionally, participants were asked to complete an adapted version of the German Patient Satisfaction Questionnaire (ZUF-8) [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] supplemented with program-specific questions to assess perceived usability and satisfaction.\u003c/p\u003e \u003cp\u003eStep 2 focused on assessing the feasibility of the study process and collecting preliminary data on the program\u0026rsquo;s potential to increase PA and reduce fatigue. Fatigue was assessed using the Chalder Fatigue Scale (CFS, [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]) to facilitate descriptive comparisons with the previous elevida trial. Additional patient-reported outcomes included depression and anxiety, measured by the Hospital Anxiety and Depression Scale (HADS, [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]); health-related quality of life, quantified by the Hamburg Quality of Life Questionnaire for MS (HAQUAMS, [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]); activities of daily living, assessed by the Frenchay Activity Index (FAI, [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]); and illness perception, measured by the Brief Illness Perception Questionnaire (IPQ, [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]). General cognitive status was screened with the Symbol Digit Modalities Test (SDMT, [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]). The Godin Leisure Time Exercise Questionnaire was used as a self-report measure of PA [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. In addition, PA in the real-world setting was monitored by a smart watch fitness tracker over the first 16 weeks. Each month during the intervention period, participants were asked another 4 activity-related questions: 1\u0026ndash;3) How often per week do you engage in a) high-intensity exercise, b) moderate exercise, c) low-intensity exercise, and 4) How often do you engage in activities that cause sweating? (answer options\u0026thinsp;=\u0026thinsp;a) 4 to 7 times/week, b) 2 to 3 times/week, c) 0 to 1 time/week. Measures were assessed at baseline (V0 before starting the intervention), at post intervention time point (V1) and one year after baseline (V2).\u003c/p\u003e \u003cp\u003e \u003cem\u003eRecruitment\u003c/em\u003e Both for Step 1 (n\u0026thinsp;=\u0026thinsp;5), and Step 2 (n\u0026thinsp;=\u0026thinsp;24), participants were recruited from the MS Day Hospital database of the UMC Hamburg Eppendorf and invited to participate by telephone or email. Eligibility screening was based on fatigue scores from the MS fatigue subscale of the HAQUAMS [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e], as noted in the database. Patients scoring\u0026thinsp;\u0026ge;\u0026thinsp;2 were contacted by telephone. Detailed information about the research project was provided either by phone or in person.\u003c/p\u003e \u003cp\u003e \u003cem\u003eInclusion criteria\u003c/em\u003e Participants were required to have an MS diagnosis according to McDonald criteria [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e], any disease course, Expanded Disability Status Scale (EDSS, [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]\u0026thinsp;\u0026lt;\u0026thinsp;4.5; FSMC total fatigue score\u0026thinsp;\u0026ge;\u0026thinsp;43; ability to read texts and to answer questionnaires via internet; internet equipment at home (PC/tablet with internet access), ability to follow a digital intervention, and willingness to participate.\u003c/p\u003e \u003cp\u003e \u003cem\u003eExclusion criteria\u003c/em\u003e included an unclear diagnosis; neuromyelitis optica; and severe psychiatric disorders (e.g., psychotic disorders, although depressive disorders were permitted).\u003c/p\u003e\n\u003ch3\u003eStatistical and descriptive analyses\u003c/h3\u003e\n\u003cp\u003e Each Step 1 interview was conducted by telephone, with participant responses recorded in writing and summarized by the interviewer. Reports were analysed by an expert psychologist (J. P\u0026ouml;ttgen) at the INIMS under the guidance of C. Heesen; representative statements were categorized.\u003c/p\u003e \u003cp\u003eBaseline analyses describe demographic and clinical data, as well as all other study specific measures (step1 \u0026amp; step 2). The longitudinal analyses (step 2) focussed on differences between measures obtained at pre-training (baseline), post-training (V1), and follow-up (V2) one year after inclusion. Effect sizes (Cohen\u0026rsquo;s d) were calculated for paired values.\u003c/p\u003e \u003cp\u003eMissing values (step 2) of daily step data or values below 200 steps/day (up to 2 missing days per week) were imputed using the weekly mean. Missing weeks (up to 3 weeks in total) were imputed by the mean of the other weeks.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eRecruitment took place (Step 1) in May 2022 and (Step 2) from March to June 2023 for the feasibility study.\u003c/p\u003e\n\u003cp\u003eOverall, five patients were included in the qualitative part of step 1, consisting of the interviews (n = 5; four women and one man); and for step 2, n = 24 patients were included (nineteen women and five men). Median age was 41 in both groups with slight differences in the ranges. Participants in step 2 were highly educated (median years of education = 15 years), the disability measured by the EDSS was low in step 2 (median = 1.3), moderate in step 1 with a wide range (1-6.5).\u003c/p\u003e\n\u003cp\u003eTable 1: Demography of pwMS\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 51.6484%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24.1758%;\"\u003e\n \u003cp\u003eStep 1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24.1758%;\"\u003e\n \u003cp\u003eStep 2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 51.6484%;\"\u003e\n \u003cp\u003eN\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24.1758%;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24.1758%;\"\u003e\n \u003cp\u003e24\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 51.6484%;\"\u003e\n \u003cp\u003eAge (median in years, (range))\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24.1758%;\"\u003e\n \u003cp\u003e41 (31-58)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24.1758%;\"\u003e\n \u003cp\u003e41 (23-61)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 51.6484%;\"\u003e\n \u003cp\u003eSex (female, (%))\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24.1758%;\"\u003e\n \u003cp\u003e4 (80)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24.1758%;\"\u003e\n \u003cp\u003e19 (79)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 51.6484%;\"\u003e\n \u003cp\u003eFamily status (n, %)\u003c/p\u003e\n \u003cp\u003esingled\u003c/p\u003e\n \u003cp\u003eMarried\u003c/p\u003e\n \u003cp\u003eDivorced\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24.1758%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e2 (40)\u003c/p\u003e\n \u003cp\u003e2 (40)\u003c/p\u003e\n \u003cp\u003e1 (20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24.1758%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e6 (25)\u003c/p\u003e\n \u003cp\u003e9 (38)\u003c/p\u003e\n \u003cp\u003e6 (25)\u003c/p\u003e\n \u003cp\u003e3 (7)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 51.6484%;\"\u003e\n \u003cp\u003eEducation (median in years, (range))\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24.1758%;\"\u003e\n \u003cp\u003en.d.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24.1758%;\"\u003e\n \u003cp\u003e15 (11-18)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 51.6484%;\"\u003e\n \u003cp\u003eWorking status\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eFull day\u003c/p\u003e\n \u003cp\u003eHalf day\u003c/p\u003e\n \u003cp\u003eHomemaker\u003c/p\u003e\n \u003cp\u003eWorkless\u003c/p\u003e\n \u003cp\u003edisabled\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24.1758%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e12 (50)\u003c/p\u003e\n \u003cp\u003e6 (25)\u003c/p\u003e\n \u003cp\u003e1 (4)\u003c/p\u003e\n \u003cp\u003e1 (4)\u003c/p\u003e\n \u003cp\u003e2 (8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24.1758%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e12 (50)\u003c/p\u003e\n \u003cp\u003e6 (25)\u003c/p\u003e\n \u003cp\u003e1 (4)\u003c/p\u003e\n \u003cp\u003e1 (4)\u003c/p\u003e\n \u003cp\u003e2 (8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 51.6484%;\"\u003e\n \u003cp\u003eImpairment (EDSS)\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eMedian (range)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24.1758%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e2.5 (1-6.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24.1758%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e1.3 (0-3)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 51.6484%;\"\u003e\n \u003cp\u003eLast relapse (n, %)\u003c/p\u003e\n \u003cp\u003eI never had relapses\u003c/p\u003e\n \u003cp\u003eIn the last 4 weeks\u003c/p\u003e\n \u003cp\u003eIn the last 6 weeks\u003c/p\u003e\n \u003cp\u003eIn the last year\u003c/p\u003e\n \u003cp\u003eMore than a year ago\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24.1758%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e1 (20)\u003c/p\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003cp\u003e3 (60)\u003c/p\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003cp\u003e1 (20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24.1758%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e5 (21)\u003c/p\u003e\n \u003cp\u003e3 (13)\u003c/p\u003e\n \u003cp\u003e5 (21)\u003c/p\u003e\n \u003cp\u003e5 (20)\u003c/p\u003e\n \u003cp\u003e6 (25)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003en.d.=no data, SD=Standard deviation, PDDS=Patient-Determined Disease Steps\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eFindings of the feasibiitly (step 1) study\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStep 1\u003c/em\u003e We tested the acceptance of the new program in n=5 MS patients. For details of demographic data, see table 1.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eQuantitative analysis of the program quality indicated high acceptance (see table 2). All participants rated the language and voice guiding the exercises and meditation tasks very positively. Specific program aspects, including illustrations, helpfulness, engagement, support, and overall pleasantness were also rated highly. None of the participants reported feeling \u0026ldquo;indoctrinated\u0026rdquo;, the content per page was considered manageable, with explanations, summaries, and worksheets all deemed to be helpful. All participants would recommend the program to other pwMS experiencing fatigue. In total, the program received high scores for quality, alignment with expectations and needs, satisfaction, and its ability to reduce fatigue.\u003c/p\u003e\n\u003cp\u003eTable 2: Perceived benefits of the program in the step 1 study\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"604\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 45.2893%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eQuestion n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ebad\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e\u003cstrong\u003enot so good\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u003cstrong\u003egood\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eexcellent\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.2893%;\"\u003e\n \u003cp\u003eHow would you rate the quality of \u0026ldquo;elevida-Go!\u0026rdquo;?\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e3/5\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e2/5\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.2893%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eNot at all\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eNo\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eYes\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ecompletely yes\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.2893%;\"\u003e\n \u003cp\u003eWas the treatment you have received in line with your expectations?\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e4/5\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e1/5\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.2893%;\"\u003e\n \u003cp\u003eDid \u0026ldquo;elevida-Go!\u0026rdquo; meet your needs?\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e1/5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e1/5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e4/5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.2893%;\"\u003e\n \u003cp\u003eWould you recommend \u0026ldquo;elevida-Go!\u0026rdquo; to a friend if he/she needed suffer from fatigue?\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e5/5\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.2893%;\"\u003e\n \u003cp\u003eAre you satisfied with the level of help you received from \u0026ldquo;elevida-Go!\u0026rdquo;?\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e2/5\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e3/5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.2893%;\"\u003e\n \u003cp\u003eDid \u0026ldquo;elevida-Go!\u0026rdquo; helped you to deal with your problems more appropriately?\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e1 (20)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e1 (20)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e3 (60)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.2893%;\"\u003e\n \u003cp\u003eAre you satisfied with \u0026ldquo;elevida-Go!\u0026rdquo; in total?\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e2 (40)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e3 (60)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.2893%;\"\u003e\n \u003cp\u003eWould you use \u0026ldquo;elevida-Go!\u0026rdquo; again?\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e2 (40)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e3 (60)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.2893%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eI totally disagree\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eI disagree\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eI agree\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eI totally agree\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.2893%;\"\u003e\n \u003cp\u003eThe language in the program is generally easy to understand.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e5 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.2893%;\"\u003e\n \u003cp\u003eI liked the illustrations.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e1 (20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e3 (60)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e1 (20)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.2893%;\"\u003e\n \u003cp\u003eThe voice of the audio artist was pleasant.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e5 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.2893%;\"\u003e\n \u003cp\u003eThe content was helpful and interesting.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e1 (20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e2 (40)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e2 (40)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.2893%;\"\u003e\n \u003cp\u003eI believe that elevida Go! will be very helpful for many people with MS fatigue.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e2 (40)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e3 (60)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.2893%;\"\u003e\n \u003cp\u003eThe way elevida Go! \u0026ldquo;spoke\u0026rdquo; to me was friendly, supportive and pleasant.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e1 (20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e4 (80)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.2893%;\"\u003e\n \u003cp\u003eThe program seemed didactic or know-it-all.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e4 (80)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e1 (20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.2893%;\"\u003e\n \u003cp\u003eThe texts per page were too long.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e2 (40)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e2 (40)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e1 (20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.2893%;\"\u003e\n \u003cp\u003eThe references and explanations of scientific studies were helpful.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e1 (20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e4 (80)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.2893%;\"\u003e\n \u003cp\u003eThe summaries and worksheets are a helpful addition to the program.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e3 (60)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e2 (40)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.2893%;\"\u003e\n \u003cp\u003eI would recommend the program to someone suffering from MS fatigue.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12.562%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14.0496%;\"\u003e\n \u003cp\u003e5 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eThe program was perceived as being mainly in line with personal expectations. One person did not feel that her personal needs were met by the program. All participants would recommend elevida-Go! to other pwMS with fatigue. All participants were satisfied with the level of help they received from the program. Four of five participants reported improved coping ability with their problems. Overall program satisfaction was very high, and all participants reported they would use it again.\u003c/p\u003e\n\u003cp\u003eRespondents were also asked to elaborate on their subjective impressions of elevida-Go! (qualitative impressions) displayed in table 3. Responses were generally consistent with the quantitative findings and confirmed the impression that patients were satisfied with the program.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 3:\u003c/strong\u003e categories of qualitative findings in step 1 study (n=5)\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"623\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 37.8812%;\"\u003e\n \u003cp\u003eDomain\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62.1188%;\"\u003e\n \u003cp\u003epatient comments\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 37.8812%;\"\u003e\n \u003cp\u003e\u003cstrong\u003epositive exercise related feedback\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62.1188%;\"\u003e\n \u003cp\u003eGood introduction of different types of exercises\u003c/p\u003e\n \u003cp\u003eUnderstandable indications of positive effects of sport\u003c/p\u003e\n \u003cp\u003eNew impulses to move\u003c/p\u003e\n \u003cp\u003eGood introduction of physical exercises\u003c/p\u003e\n \u003cp\u003eProvided exercises are easy to implement in everyday life\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 37.8812%;\"\u003e\n \u003cp\u003e\u003cstrong\u003epositive program related feedback\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62.1188%;\"\u003e\n \u003cp\u003eSurprising versatility of the program in total\u003c/p\u003e\n \u003cp\u003ePhysical activities and meditation work well together\u003c/p\u003e\n \u003cp\u003eApp is easy to use on tablet, computer or smartphone\u003c/p\u003e\n \u003cp\u003eClear and easily understandable language\u003c/p\u003e\n \u003cp\u003eInspirating daily SMS with thoughts for the day\u003c/p\u003e\n \u003cp\u003eNice photos and illustrations\u003c/p\u003e\n \u003cp\u003ePleasant voice of the speaker\u003c/p\u003e\n \u003cp\u003eAppealing relaxation exercises\u003c/p\u003e\n \u003cp\u003eThe system was explained well\u003c/p\u003e\n \u003cp\u003eThe audios are good\u003c/p\u003e\n \u003cp\u003eProvided case studies were helpful\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 37.8812%;\"\u003e\n \u003cp\u003e\u003cstrong\u003epositive motivational feedback\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 62.1188%;\"\u003e\n \u003cp\u003eThe program motivates me to workout at home\u003c/p\u003e\n \u003cp\u003eThe letters to the friend are good/engaging\u003c/p\u003e\n \u003cp\u003eThe explanations of the meaning of exercising were motivating\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eThe program encourages reflection\u003c/p\u003e\n \u003cp\u003eI felt understood\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 37.8812%;\"\u003e\n \u003cp\u003e\u003cstrong\u003enegative exercise-related feedback\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 62.1188%;\"\u003e\n \u003cp\u003eOptions for people who already do a lot of sports were missing\u003c/p\u003e\n \u003cp\u003eThe program is frustrating for wheelchair users\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 37.8812%;\"\u003e\n \u003cp\u003e\u003cstrong\u003enegative program-elated feedback\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 62.1188%;\"\u003e\n \u003cp\u003eThe links for scientific sources in the text were too tedious\u003c/p\u003e\n \u003cp\u003eYou have to sit down and actively listen, which can be difficult with fatigue\u003c/p\u003e\n \u003cp\u003eModules are too long\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 37.8812%;\"\u003e\n \u003cp\u003e\u003cstrong\u003enegative motivational feedback\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 62.1188%;\"\u003e\n \u003cp\u003etoo much journaling required\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 37.8812%;\"\u003e\n \u003cp\u003e\u003cstrong\u003egeneral tips\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 62.1188%;\"\u003e\n \u003cp\u003eProviding a separate list for literature references of studies\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eActivity-based alternatives would be good\u003c/p\u003e\n \u003cp\u003eProviding links to exercise programmes for people on low incomes\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eResults of the qualitative analyses were used to slightly adapt relevant text passages of the program.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eFindings of the pilot cohort study (step 2)\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIn step 2, we collected data to estimate the uncontrolled effects of elevida-Go! in improving fatigue and other relevant variables. We recruited 24 participants; their demographic data are displayed in table 1.\u003c/p\u003e\n\u003cp\u003ePreliminary data of improvements in neuropsychiatric measures are reported in table 4. Data from one person was lost at the post assessment time-point. We observed improvements in fatigue, daily activity, anxiety, self-reported exercising, and quality of life (subscales fatigue, cognition, upper limbs, mood and total score). No improvements were observed on measures of cognition, depression, perceived illness, and QoL subscales communication and lower limbs.\u003c/p\u003e\n\u003cp\u003eTable 4: Data of the baseline and post-assessments in the pilot study (significant effects 0\u0026lt;.05 are in bold)\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"614\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 18.4039%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003eBaseline mean\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003ePost\u003c/p\u003e\n \u003cp\u003eMean (n=23)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003eCohen\u0026rsquo;s d (CI)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003eFollow up \u0026nbsp; mean (n=21)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003eCohen\u0026rsquo;s d (CI)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.4039%;\"\u003e\n \u003cp\u003eCFS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e22.0 (5.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e13.0 (6.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1.10 (.57 to 1.61)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e14.4 (4.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1.03 (.49 to 1.55)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.4039%;\"\u003e\n \u003cp\u003eFAI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e32.8 (7.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e39.3 (7.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e.96 (.46 to 1.45)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e36.1 (7.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e.62 (.14 to 1.08)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.4039%;\"\u003e\n \u003cp\u003eSDMT\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e54.1 (8.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e54.7 (9.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e.06 (-.54 to .41)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.4039%;\"\u003e\n \u003cp\u003eHADS Depr.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e7.0 (4.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e6.0 (3.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e.26 (-.16 to .67)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e6.2 (3.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e.33 (-.12 to .76)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.4039%;\"\u003e\n \u003cp\u003eHADS Anxiety\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e9.1 (4.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e8.0 (3.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e.41 (-.02 to .83)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e7.7 (3.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e.46 (.02 to .92)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.4039%;\"\u003e\n \u003cp\u003eGodin\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e34.2 (20.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e45.0 (24.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e.47 (.04 to .90)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e39.5 (20.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e.40 (-.84 to .05)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.4039%;\"\u003e\n \u003cp\u003eIPQ\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e45.8 (7.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e45.4 (9.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e.05 (-.36 to .46)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.4039%;\"\u003e\n \u003cp\u003eHAQUAMS Fatigue\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e13.6 (3.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e12.2 (3.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e.39 (-.41 to .81)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.4039%;\"\u003e\n \u003cp\u003eHAQUAMS Cognition\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e13.1 (3.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e11.6 (4.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e.46 (.03 to .89)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.4039%;\"\u003e\n \u003cp\u003eHAQUAMS Lower limbs\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e7.5 (3.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e7.3 (3.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e.10 (-.31 to .51)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.4039%;\"\u003e\n \u003cp\u003eHAQUAMS Upper limbs\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e7.9 (3.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e7.2 (3.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e.43 (-.01 to .85)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.4039%;\"\u003e\n \u003cp\u003eHAQUAMS Communication\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e14.3 (4.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e14.0 (4.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e.11 (-.30 to .52)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.4039%;\"\u003e\n \u003cp\u003eHAQUAMS Mood\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e14.0 (3.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e12.3 (4.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e.48 (.42 to .91)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 18.4039%;\"\u003e\n \u003cp\u003eHAQUAMS total\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e70.3 (15.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e64.5 (16.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e.57 (.13 to .98)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13.8436%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.0326%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eFollow up-data (1 year after pre assessment, median 363 days, range(309-403)) in n=21 pwMS suggested long-term beneficial effects of elevida-Go! on fatigue (CFS), daily activity (FAI) and anxiety (HADS).\u003c/p\u003e\n\u003cp\u003eThe measured step data collected by a smartwatch during the intervention and reported by participants were evaluated \u0026nbsp;based on the steps per week over the first 16 weeks (see figure 1). Daily steps increased slightly between the first and the 9\u003csup\u003eth\u003c/sup\u003e week; however, daily steps then appeared to decrease slightly for the next seven weeks.\u003c/p\u003e\n\u003cp\u003eSelf-reported exercise data (table 6) show a slight increase from month 1 to month 2 for moderate and low-intensity exercises, with subsequent slight reductions. For high-intensity exercise, the number decreased slightly from month 1 to month 2, and also to month 3. Also, intensive exercise causing sweating decreased over time, except for an increase for answer b) (2 to 3 times a week).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTable 6: Reported active training sessions\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" align=\"\" width=\"567\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 46.0317%;\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 16.7549%;\"\u003e\n \u003cp\u003e\u003cem\u003emonth 1\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e(n=22)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.8713%;\"\u003e\n \u003cp\u003e\u003cem\u003emonth 2\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e(n=23)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.3422%;\"\u003e\n \u003cp\u003e\u003cem\u003emonth 3\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e(n=20)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 46.0317%;\"\u003e\n \u003cp\u003e1-3) How often do you do per week (mean (range))\u003c/p\u003e\n \u003cp\u003ea) effortful exercises\u003c/p\u003e\n \u003cp\u003eb) moderate exercises\u003c/p\u003e\n \u003cp\u003ec) effortless exercises?\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 16.7549%;\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e1.1 (0-4)\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e3.0 (0-7)\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e4.4 (0-7)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.8713%;\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e1.0 (0-4)\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e3.8 (0-14)\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e5.0 (1-14) \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.3422%;\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e0.9 (0-4)\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e2.5 (0-14)\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e4.5 (0-21)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 46.0317%;\"\u003e\n \u003cp\u003e4) How often do you do sports that make you sweat? (n (%))\u003c/p\u003e\n \u003cp\u003ea) 4 to 7 times a week\u003c/p\u003e\n \u003cp\u003eb) 2 to 3 times a week\u003c/p\u003e\n \u003cp\u003ec) 0 to 1 time a week\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 16.7549%;\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e6 (28)\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e8 (36)\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e8 (36)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.8713%;\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e7 (30)\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e8 (35)\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e8 (35)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.3422%;\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e4 (20)\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e11 (55)\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e5 (25)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cem\u003eProgram usage\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAll 24 participants started with the elevida-Go! Program; the median of numbers of finished modules was 7 (54%). Whereas 7 (29%) participants finished all 13 modules, one participant only started the first module but did not finish it. Fifteen (63%) participants finished 7 or more modules, and 5 (21%) persons less than 4. The mean amount of time participants engaged in the intervention was 5.0 hours (range from 0.2 to 9.7 hours).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study reports on the further development of a regulated digital health application (elevida) for pwMS. In addition to the original nine modules, four new modules focused on PA were developed and integrated into the existing elevida program, and the resulting integrated program was termed elevida-Go!. These new modules were embedded in the CBT program elevida, which targets fatigue among pwMS.\u003c/p\u003e \u003cp\u003eThe beneficial effects of CBT on MS fatigue have been summarized in recent reviews [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. The positive influence of PA on MS-associated fatigue has rarely been studied as a primary treatment goal in exercise studies; a systematic review [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e] indicates efficacy based on studies investigating fatigue as a secondary outcome, whereas a larger 16-week randomised controlled trial (RCT) with aerobic training in pwMS with severe fatigue did not find beneficial effects [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. To our knowledge, a combined training program consisting of a CBT-based program in combination with intervention elements to promote exercise and PA to treat MS fatigue has not yet been developed in digital or personally delivered format.\u003c/p\u003e \u003cp\u003eOur pilot study revealed generally positive feedback regarding the program, and prospective data suggested beneficial effects on fatigue and other outcomes.\u003c/p\u003e \u003cp\u003eInitially, a small group of pwMS were asked to rate their satisfaction and acceptance of the first prototype of elevida-Go!. Suggestions for improvement and recommendations from the participants were noted and used for program adaptations and fine-tuning. Overall, participants reported a positive impression of the program\u0026rsquo;s quality, satisfaction with its content, and a perceived improvement in fatigue. All participants found the program easy to understand and would recommend it to other people with MS (pwMS) who experience MS-related fatigue. The program\u0026rsquo;s motivational aspect, encouraging participants to become more active and follow an exercise plan, was highlighted. However, a few participants noted that some modules felt lengthy and expressed a desire for more suggestions tailored to individuals with greater disabilities.\u003c/p\u003e \u003cp\u003eThe pilot study suggested robust improvements on a variety of key outcomes, including fatigue, daily activity, anxiety, self-reported exercising, and quality of life. The pre-post effect sizes were in the medium and even large range for several of these variables, although the absence of a control group prohibits clear causal conclusions. Nevertheless, in the context of positive effects of PA on fatigue observed in previous studies [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e], these pilot results appear promising and suggest that adding PA-focused modules may have enhanced the already robust effect of elevida on fatigue reductions over time. Our large trial investigating elevida was our first attempt to treat MS fatigue via a digital intervention, and it showed positive effects on other outcomes as well, including anxiety, daily activity and quality of life [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Within this pilot study using elevida-Go! the positive effect on fatigue is even higher (1.10 (.57 to 1.61) vs. 0.53 (\u0026minus;\u0026thinsp;4.32 to 1.16). In addition, we were able to replicate the improvements in anxiety, quality of life, and daily activity. This study also showed improvements in self-rated activity behaviour.\u003c/p\u003e \u003cp\u003eThe beneficial effects of PA and exercise on MS fatigue have been well documented recent years, although several studies also suggest that pwMS tend to do exercise less than healthy individuals [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. Motivating pwMS to increase their PA levels represents a major challenge for neurologists, physiotherapists, psychotherapists and other pwMS health care providers. The maintenance of exercise behaviour change is a problem in MS, but also in the general population [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. Current treatment options in Germany are usually limited to periodic inpatient rehabilitation treatments. Researchers have highlighted the need to include theory-based behavioral approaches for long-term behavior change. In a randomized controlled pilot trial of a community-delivered exercise program combined with behavior change techniques in people with MS (pwMS), Hayes et al. [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e] could show significant effects on physical activity in pwMS after 10 and 36 weeks. Digital health applications can help bridge this gap by offering easily accessible information on the importance of exercise for pwMS and by conveying motivational and therapeutic techniques that facilitate relevant behavior change. Based on the theories of behavior change, strategies such as information provision, goal setting, barrier recognition, self-monitoring, and social support are essential therapeutic components. Cognitive behavioral therapy can incorporate these and other elements to support the adoption of appropriate PA habits. Both elevida and elevida-Go! are grounded in a broad range of behavior change techniques and CBT methods, although future research is needed to disentangle the pathways and mechanisms through which beneficial effects unfold. In our pilot trial we could show the beneficial long-term effect (over 1 year) of the CBT-based eHealth intervention elevida-Go! on fatigue, daily activity and anxiety. We lost only 3 (13%) pwMs at the follow up timepoint at V2 (1 year after baseline). This low drop-out rate underlines participants\u0026rsquo; acceptance and satisfaction with elevida-Go!.\u003c/p\u003e \u003cp\u003eFewer than half of the participants (29%) completed all 13 modules, the average number completed was 7 (54%). Compared to a recent review studying the adherence rate for eHealth interventions to treat depression, the adherence rate in our pilot trial was slightly below the mean level of adherence in other studies [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. However, studies have found many factors influencing adherence, including age, recruitment sourced (internet vs. in care centers), and gender [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. In our trial, more than half of participants (63%) completed at least 7 of 13 modules. Unfortunately, we did not assess the reasons for attrition by interviewing the participants. Regarding the drop-out rate, we lost only one person in the primary study trial at the post assessment timepoint.\u003c/p\u003e \u003cp\u003eOur data from a small sample of 24 pwMS provides preliminary evidence of the positive effects of elevida-Go!. In addition to fatigue reduction, participants also reported some improvements in everyday activity, anxiety, and quality of life, along with increases in self-reported PA. Comparable with findings in the large elevida RCT [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e] we also did not find an impact on depression and cognitive complaints. Notably, the beneficial effects appeared to remain stable over a period of 1 year, although self-perceived bodily activity decreased somewhat over time. In addition, the number of steps did not change over the intervention period. Unfortunately, no baseline data was collected for step count, limiting conclusions on this parameter.\u003c/p\u003e \u003cp\u003eSeveral limitations need to be noted. As this feasibility cohort was small and the study lacked a control group, conclusions on causality are not possible. In addition, the sample consisted of pwMS who were recruited only from the UKE\u0026rsquo;s MS day clinic in Hamburg, which may have introduced selection bias, as participants were likely already inclined to be more active and most of participants had low disability levels. The adherence rate was lower than other eHealth trials, likely due to the high number of modules (14). Furthermore, no baseline assessment was available for some outcomes, which restricts the scope of our analysis.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eIn conclusion the results of elevida-Go! show potential to enhance PA levels among pwMS, thereby potentially reducing MS-related fatigue. In addition to alleviating fatigue, increased PA may interact with other MS symptom domains and could potentially influence disease-related inflammatory and neurodegenerative processes. These encouraging findings suggest that larger and more controlled trials are warranted to confirm and extend these effects.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eCBT\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Cognitive Behavioral Therapy\u003c/p\u003e\n\u003cp\u003eCFS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Chalder Fatigue Scale\u003c/p\u003e\n\u003cp\u003eCI\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Confidence interval\u003c/p\u003e\n\u003cp\u003ed\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Cohen\u0026rsquo;s effect size\u003c/p\u003e\n\u003cp\u003eEDSS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Expanded Disability and Status Scale\u003c/p\u003e\n\u003cp\u003eFAI\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Frenchay Activity Index\u003c/p\u003e\n\u003cp\u003eFSMC\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Fatigue Sclae for Motor and Cognition\u003c/p\u003e\n\u003cp\u003eGAIA\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Digital Therapeutics Business Company\u003c/p\u003e\n\u003cp\u003eHADS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Hospital Anxiety and Depression Scale\u003c/p\u003e\n\u003cp\u003eHAQUAMS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Hamburg Quality of Life Questionnaire for Multiple Sclerosis\u003c/p\u003e\n\u003cp\u003eINIMS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Institute of Neuroimmunology and Multiple Sclerosis\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIPQ Illness Perception Questionnaire\u003c/p\u003e\n\u003cp\u003eMS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Multiple Sclerosis\u003c/p\u003e\n\u003cp\u003en.d.\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;no data\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePA\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Physical Activity\u003c/p\u003e\n\u003cp\u003ePDDS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Patient Determined Disease Steps\u003c/p\u003e\n\u003cp\u003ePwMS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Person with Multiple Sclerosis\u003c/p\u003e\n\u003cp\u003eQoL\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Quality of Life\u003c/p\u003e\n\u003cp\u003eRCT\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Randomized Controlled Trial\u003c/p\u003e\n\u003cp\u003eSD\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Standard Deviation\u003c/p\u003e\n\u003cp\u003eSDMT\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Symbol Digit and Modalities Test\u003c/p\u003e\n\u003cp\u003eSME\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Smal-to- medium enterprice\u003c/p\u003e\n\u003cp\u003eUKE\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;University Medical Center Hamburg Eppendorf\u003c/p\u003e\n\u003cp\u003eUMC\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;University Medical Center\u003c/p\u003e\n\u003cp\u003eV\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Visit\u003c/p\u003e\n\u003cp\u003eZUF-8 \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; German Patient Satisfaction Questionnaire\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study has been approved by the Ethics Committee of the Hamburg Chamber of Physicians (2021-100717-BO-ff) and written informed consent was obtained from all participants.\u003c/p\u003e\n\u003cp\u003eThis study adhered to the Declaration of Helsinki (2013).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll data/materials are available, please contact the corresponding author.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare no competing interests.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis research was supported by the\u0026nbsp;\u003cem\u003eBMS Investigator Sponsored Research Program.\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eJana P\u0026ouml;ttgen: Conceptualisation; Funding acquisition; Data curation; Formal analysis; Investigation; Methodology; Project administration; Visualisation; Writing \u0026ndash; original draft.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eStephanie Lau: Conceptualisation; Methodology; Resources; Supervision; Writing \u0026ndash; review \u0026amp; editing.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eBj\u0026ouml;rn Meyer: Conceptualisation; Methodology; Resources; Writing \u0026ndash; review \u0026amp; editing.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eChristoph Heesen: Conceptualisation; Funding acquisition; Investigation; Methodology; Project administration; Resources; Supervision; Writing \u0026ndash; review \u0026amp; editing.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to thank Susan Seddiq Zai for her contribution to the logistics of the trial, data acquisition, quality control, and data management.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eLe HH\u003cstrong\u003e, \u003c/strong\u003eKen-Opurum J\u003cstrong\u003e, \u003c/strong\u003eLaPrade A\u003cstrong\u003e, \u003c/strong\u003eMaculaitis MC\u003cstrong\u003e, \u003c/strong\u003eSheehan JJ. 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Assessing Patient Adherence to and Engagement With Digital Interventions for Depression in Clinical Trials: Systematic Literature Review. \u003cem\u003eJournal of Medical Internet Research\u003c/em\u003e 2023; \u003cstrong\u003e25: \u003c/strong\u003ee43727\u003c/li\u003e\n\u003cli\u003eFuhr K\u003cstrong\u003e, \u003c/strong\u003eSchr\u0026ouml;der J\u003cstrong\u003e, \u003c/strong\u003eBerger T\u003cem\u003e, et al.\u003c/em\u003e The association between adherence and outcome in an Internet intervention for depression. \u003cem\u003eJournal of affective disorders\u003c/em\u003e 2018; \u003cstrong\u003e229: \u003c/strong\u003e443\u0026ndash;9\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"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":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Multiple Sclerosis, fatigue, exercise, physical activity, cognitive behavioural therapy, fatigue training","lastPublishedDoi":"10.21203/rs.3.rs-6548074/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6548074/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eThe cognitive behavioral therapy (CBT) based digital health application \u003cem\u003eelevida\u003c/em\u003e has been shown to reduce Multiple Sclerosis (MS)-related fatigue, and there is substantial evidence that exercise can also alleviate fatigue. However, the combined effect of CBT and exercise remains unknown.\u003c/p\u003e\u003ch2\u003eObjective\u003c/h2\u003e \u003cp\u003eTo develop a combined CBT and exercise intervention for MS fatigue and evaluate its acceptance, feasibility and preliminary effectiveness.\u003c/p\u003e\u003ch2\u003eMethod\u003c/h2\u003e \u003cp\u003eTo expand elevida\u0026rsquo;s exercise-related content, four new modules were developed and adapted based on qualitative feedback from persons with MS (pwMS). A single-arm feasibility study was conducted with MS patients using the resulting program, which was termed \u003cem\u003eelevida-Go!\u003c/em\u003e. Acceptance data were gathered through standardized qualitative interviews, while initial efficacy was assessed after 4 and 6 months. Daily steps were measured by a digital step counter over the first 4 months. Further outcomes included patient-rated fatigue, information processing speed, depression, anxiety, daily activity, physical activity (PA), and quality of life (QoL). T-tests for dependent measures were computed to analyze feasibility.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eFive pwMS (n\u0026thinsp;=\u0026thinsp;4 female, age M\u0026thinsp;=\u0026thinsp;41 years, range 31\u0026ndash;58) participated in the qualitative evaluation and rated the quality of the program as very good, generally meeting their expectations. All participants were satisfied with the level of help received and would recommend the program to other pwMS with fatigue, and 4 of 5 participants reported that it had improved their ability to cope with their problems. In the feasibility study (n\u0026thinsp;=\u0026thinsp;24, 79% female, age M\u0026thinsp;=\u0026thinsp;41 years, range 23\u0026ndash;61) acceptance and usability of the expanded programme was confirmed as high. Pre-post analyses showed improvements in fatigue (d\u0026thinsp;=\u0026thinsp;1.10, CI\u0026thinsp;=\u0026thinsp;.57 to 1.61), daily activity (d\u0026thinsp;=\u0026thinsp;.93, CI\u0026thinsp;=\u0026thinsp;.46 to 1.45), physical activity (d\u0026thinsp;=\u0026thinsp;.47, CI\u0026thinsp;=\u0026thinsp;.04 to .90), anxiety (d\u0026thinsp;=\u0026thinsp;.41, CI=-.02 to .83), and QoL (d\u0026thinsp;=\u0026thinsp;.57, CI\u0026thinsp;=\u0026thinsp;.12 to 1.01). Improvements in fatigue, daily activity, and anxiety persisted at the 6-month follow-up.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eElevida-Go! demonstrated high acceptability and usability among study participants. Preliminary efficacy data appear promising, warranting further investigation in a randomized controlled trial.\u003c/p\u003e","manuscriptTitle":"Elevida-Go! – a digital treatment program to improve fatigue in MS by CBT and exercise: findings from a feasibility study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-05-19 09:21:15","doi":"10.21203/rs.3.rs-6548074/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"7eb0e381-9b97-4409-b6ea-a6047641c009","owner":[],"postedDate":"May 19th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-06-11T10:53:15+00:00","versionOfRecord":[],"versionCreatedAt":"2025-05-19 09:21:15","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6548074","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6548074","identity":"rs-6548074","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}