Practice Points
- Home-based, structured exercise training is feasible and acceptable for people with multiple sclerosis (MS) who use wheelchairs.
- An arm ergometer and resistance bands are appropriate, low-cost, home-based exercise training equipment for people with MS who use wheelchairs.
Exercise training is a safe and beneficial approach for rehabilitation and symptom management in multiple sclerosis (MS).1-3 Exercise training can be undertaken by following prescriptive guidelines, and the guidelines have been extended to include nonambulatory people with MS.4,5 This is important as approximately 30% of people living with MS identify use of a wheeled mobility device as a primary assistive device, and this subpopulation may benefit most from exercise as an adjunct therapy, given the lack of available disease-modifying therapies for later stages of MS disability.6 Nevertheless, clinical trials of exercise training in MS almost exclusively require ambulation and/or relapsing-remitting disease courses.7 This presents a major gap in evidence-based programs for the promotion of exercise training among people with MS who use wheelchairs, despite the extension of guidelines to include them based on clinical experience alone.
We undertook a series of developmental research steps to create an exercise training program for people with MS who use wheelchairs. Our foundational qualitative inquiry identified that their exercise preferences were consistent with those of the broader MS population.8 The initial qualitative study identified key themes that included a preference for both strength and aerobic training and home- or community-based exercise.8 The preferences aligned with an evidence-based exercise training intervention called Guidelines for Exercise in MS (GEMS). The GEMS approach was developed for people with MS who had mild or moderate walking disability and focused on meeting the guidelines for exercise in people with MS.5,9 Those guidelines specify moderate-intensity aerobic exercise (eg, walking) 2 times per week for 30 or more minutes and resistance training exercises targeting the major muscle groups using resistance bands 2 times per week. The prescription for intensity is a 4 to 6 on a 10-point Rate of Perceived Exertion scale. Using a community-engaged research design, the GEMS program was adapted for people with MS who use wheelchairs. A community advisory board of 10 people with MS who use wheelchairs provided feedback on all components of GEMS (ie, exercise prescription, coaching, and equipment).10 The adaptations included arm cycling as an aerobic modality and providing 12 social cognitive theory (SCT)–based video chats to support behavior change. The research team implemented these changes and convened 3 focus groups to guide and approve the final wheelchair exercise program.11
The current study tested the feasibility, acceptability, and preliminary efficacy of an adapted 16-week GEMS program for people with MS who use wheelchairs: the Seated Physical Activity INtervention (SPIN).12 Feasibility was based on recruitment and retention rates, as well as safety outcomes. Acceptability was assessed as participant satisfaction and perceptions measured in postintervention formative surveys and interviews. Preliminary efficacy was assessed on outcomes of interest (ie, metabolic health, MS symptoms, and exercise behavior change) to determine effect size and sample size estimates to power a larger clinical trial per the National Institutes of Health Stage Model for Behavioral Intervention Development.13
Methods
Study Overview
The study was registered on ClinicalTrials.gov (NCT05888727), and we published a protocol manuscript providing a comprehensive overview of our a priori plans.12 The study was approved by The University of Texas Health Science Center at Houston Institutional Review Board and occurred from November 2023 through May 2025. The design was a randomized controlled trial in which participants were randomly assigned into exercise training (SPIN) or attention/control wellness (WEllness for Longevity Living With MS; WELL) conditions. Both conditions were grounded in SCT and focused on the overall well-being of people with MS who use wheelchairs. Baseline and postintervention (16-week) assessments were conducted for feasibility, acceptability, and efficacy outcomes.
Participants
Participants were recruited from various sources, including neurology clinics, the National MS Society, iConquerMS listserv, and MS support groups throughout Texas. Participants were recruited in 3 distinct waves that followed a consistent schedule. A study flyer was distributed, and interested individuals completed a structured telephone screening to assess eligibility. The inclusion criteria were a diagnosis of MS; self-reported use of a wheelchair (ie, manual wheelchair, power wheelchair, or scooter) 50% or more of the time; aged 18 years or older; relapse-free for the past 30 days; and nonactive. Nonactive was defined as not engaging in regular physical activity (30 minutes accumulated per day) on more than 2 days of the week during the previous 6 months (ie, not meeting current MS physical activity guidelines). During telephone screening, we used the Physical Activity Readiness-Questionnaire as an exercise preparticipation health screen, and if individuals had 2 or more affirmative responses, we obtained signed physician clearance.14 Only 1 participant required physician clearance. Individuals who were interested and deemed eligible then completed informed consent via video call.
Participants self-reported demographic and clinical characteristics, including age, sex, marital status, employment status, race/ethnicity, education, MS clinical type, MS disease duration, and disability status, using the single-item Patient-Determined Disease Steps (PDDS) scale.15
Procedures
Once participants were enrolled, we mailed them baseline study materials to complete before randomization. The materials included an accelerometer, which participants were instructed to wear on their nondominant wrist during waking hours for 7 consecutive days to measure physical activity. Participants were asked to undergo a blood draw at a clinic to assess metabolic health outcomes and to complete a set of baseline questionnaires using REDCap that gathered demographic and clinical characteristics, as well as a battery of surveys, including the Godin Leisure Time Exercise Questionnaire (GLTEQ), Fatigue Severity Scale, short-form McGill Pain Questionnaire, Hospital Anxiety and Depression Scale (HADS), and Multiple Sclerosis Impact Scale.16-20
After completing baseline assessments, participants were randomly assigned into 1 of the 2 conditions using the REDCap randomization module created by a blinded member of the study team. Condition-specific study materials were then mailed to participants. An introductory call was conducted to ensure participants understood the study procedures and received their materials. The 16-week intervention period then commenced, during which participants engaged in structured activities based on their assigned condition. They participated in 12 behavioral coaching calls and completed weekly self-monitoring log forms using REDCap. After the intervention, participants completed a postintervention assessment that mirrored the baseline data collection process with an additional acceptability survey. All participants were invited to participate in a qualitative interview regarding their satisfaction, program feasibility, and potential areas for improvement.
Study Conditions
Table S1 (all supplemental materials are provided in a PDF at the end of the online article) provides a comprehensive overview and comparison of the study conditions.
SPIN Intervention
The SPIN program is an exercise intervention based on the FITT (frequency, intensity, time, and type) principles, focused on strength and aerobic training tailored to individuals who use wheelchairs. The program included 15 structured exercises emphasizing seated strength training with resistance bands and wrist weights, of which participants selected 10 exercises to do throughout the program. The aerobic training included arm ergometry. Participants engaged in these activities twice per week throughout the 16-week intervention with an individualized titration outlined in the protocol manuscript.12
WELL Control
The WELL control condition was identified as an appropriate comparator for the current study using the criteria published by the National Institutes of Health Office of Behavioral and Social Sciences Research.21 Specifically, the WELL materials purposefully avoid mention of exercise, but the tools and intervention dose they offer to participants are similar to SPIN, and coaching calls include SCT concepts of self-monitoring, goal setting, action planning, and problem solving. The WELL program was designed to address wellness-related topics relevant to individuals with MS (eg, stress, emotions, diet, sleep, balance, and fatigue). The program also followed the same delivery schedule as SPIN, with weekly sessions for the first 8 weeks and biweekly sessions for the remainder of the study.
The behavioral coaches facilitated both programs, guiding participants through their assigned condition. All participants received structured materials, including manuals, newsletters, logbooks, and calendars, to support their engagement and adherence throughout the study.
Measures
Feasibility
Feasibility was determined based on attaining targeted recruitment (N = 24) during a 1-year period and retention rates (≥ 80%) monitored via a study database and reported in a flow diagram (Figure). Safety was monitored by documenting adverse event (AE) incidence date, reporting rate, category, severity, relatedness to the study, and outcome using a dedicated REDCap database.
Acceptability
Acceptability was measured using participant evaluations via surveys and semistructured interviews after completing the intervention. These measures captured participants’ perceptions of the program, including ease of participation, overall experience, and expectations to continue with the intervention beyond the study period.
Efficacy
Efficacy outcomes were based on changes in metabolic health markers (eg, hemoglobin A1c, cholesterol, glucose, and triglycerides) measured via a fasted blood sample. Participants completed self-reported measures of fatigue, pain, anxiety, depression, and health-related quality of life.12,14-20 Exercise behaviors were self-reported using the GLTEQ,20 and participants completed a weekly form in an individual REDCap portal with the information recorded in the logbook as an additional measure of adherence with the assigned condition. Free-living physical activity was measured using ActiGraph model GT3X+ accelerometers (ActiGraph Corporation) using a standard 7-day period (ie, previous week) wrist-worn protocol during pretest and posttest assessments as an exploratory outcome of interest. There are currently no validated cut points for levels of physical activity (ie, light, moderate, and vigorous) among users of manual and power wheelchairs. Therefore, we examined changes in Vector Magnitude data across valid days (ie, 10 hours or more of wear time) to quantify changes in physical activity between the baseline and 16-week postintervention data collection periods.
Fidelity
Fidelity was measured through monitoring protocols for the 5 National Institutes of Health Behavior Change Consortium (NIH BCC)–recommended areas.22 Table 1 includes the strategies incorporated in the protocol and results that ensured the conditions were delivered as intended.
Data Analyses
Participant characteristics for continuous variables are reported as mean (SD) or median (IQR), and categorical measures are presented as counts (%). The analysis used the intent-to-treat (ITT) principle, in which participants were analyzed according to trial arm assignment, regardless of whether they completed the trial and final outcome assessments. Any missing data were handled using the last observation carried forward. In addition, a completer analysis was applied on the actual data collected (case-wise deletion). Descriptive statistics, including frequencies and percentages, assessed the metrics for the feasibility and acceptability outcomes. The scientific outcomes were examined using 2 (time) × 2 (group) mixed-factor analysis of variance with estimation of Cohen d as effect size. Participant change in scientific outcomes was further examined and compared with the 0.5 or more SD improvement over baseline considered to be meaningful change.23 Regarding qualitative data, we used a rapid qualitative analysis (RQA) to produce timely, actionable findings as appropriate for feasibility clinical trials. A standard RQA protocol was followed, with all steps completed in collaboration by the first and second authors.24 The RQA protocol included creating domain names for each question, use of a summary template, initial coding of a subset of interviews for calibration among team members, transfer of summaries into a matrix, and final synthesis provided in the Results. We used SPSS version 25 (IBM) for analyses.
Results
Participants
Participants (N = 24) who enrolled in the study had a mean age of 54.8 years and a mean MS duration of 15.7 years (Table 2). Nearly half had primary progressive MS, and 46% used a power wheelchair. The median (IQR) PDDS score was 7 (0), indicating self-reported severe disability. Most participants were female, and the sample was racially diverse. Ninety-one percent completed at least some college, 83% reported not being employed, and 12 participants reported a household income of $50,000 or less.
Feasibility
The primary outcomes of interest were process and resource feasibility, assessed by meeting a priori go/no-go benchmarks for recruitment (n = 24) and retention (≥ 80% of participants remain enrolled for the full 16-week study period). Of possible participants who completed the telephone screening, 20% were not eligible, with the primary reason being that they were currently physically active. Twenty-four participants were enrolled, meeting the recruitment benchmark, but 1 was lost to follow-up. Then 3 more participants dropped out: 1 reported time concerns, 1 reported mental health concerns, and 1 stopped responding to the research team contacts after week 4 without giving a reason. Thus, 20 participants (83.3%, above the 80% goal) were retained to study completion. Of these 20, 10 were assigned to the SPIN condition and 10 to the WELL condition.
The a priori benchmark for safety was incidence of AEs related to the study protocol among 10% or fewer participants. Collectively, 7 nonsevere AEs were reported among 6 participants (SPIN n = 4; WELL n = 2), only 1 of which was related to the study. The study-related AE was the presence of back pain, reported by a SPIN participant due to an improper arm ergometer setup, which was successfully addressed during a behavioral coaching call. The participant reported that the pain had resolved after altering the ergometer setup. All other reported AEs were deemed unrelated to the research and included 2 infection-related hospitalizations, a slipped disc identified during unrelated imaging, a hospitalization to conduct a cognitive assessment, a potential relapse that was managed at home, and a fall that was managed with outpatient services. This analysis of AEs meets the a priori safety benchmark.
Additional measures of process, resource, and management feasibility were collected during the study period. One participant was disappointed with the assignment to the WELL control condition but completed the assigned condition, and our team provided them with exercise resources following the postintervention assessment. Several participants reported being in physical therapy (PT) during their screening, which triggered internal eligibility discussions, and it was determined that PT was not exercise training. Implementing a standard screening tool would help resolve this issue.
Some notable barriers arose during the delivery of the intervention. Participant-reported reasons for withdrawal were consistent with common barriers to participation in clinical trials among those who use wheelchairs. To eliminate access barriers, we provided a data-enabled tablet to participants without internet access, and only 1 participant requested one. Many participants needed a caregiver to provide technical support, including participating in teleconferencing calls and initial set-up of exercise equipment. All assessments (ie, blood draw, questionnaires, and wrist-worn accelerometry) were completed by 60% of the final sample; the primary barrier for those who did not complete all assessments was lack of transportation for the blood draw. One participant asked their home nurse to complete the blood draw, but the nurse was not qualified, and another participant had a hold on their laboratory account from other medical appointments that prevented them from completing the assessment. Several accelerometers were lost by the courier, and we implemented formal package tracking starting with the postintervention assessments for wave 1. One participant never completed the final survey despite receiving regular reminders for over a month after the intervention. Exercise equipment costs for the intervention condition included resistance bands ($25), wrist weights ($34), Fitbit (Google; $150), and arm ergometer ($110) for a total of $319 per participant.
Table 1 details the published fidelity monitoring protocol.12 Briefly, there was a change in coaching plans due to the primary coach going on parental leave in week 10 of wave 2. This led our team to create and test formal provider training materials, resulting in no coaching delays for participants. All coaching call implementation checklists were completed, with 5 instances in which coaches noted that not all items assigned for a coaching call were discussed. The mean (SD) call length was comparable across conditions (SPIN = 16.5 [5.2] minutes; WELL = 14.9 [5.6] minutes), and no deviations in treatment delivery were reported. The mean (SD) number of calls completed, including the introduction call and 12 chats (13 calls total) for each condition, was 12.7 (0.5) for SPIN and 12.8 (0.4) for WELL. At the end of the study, 24 coaching call audits were completed (n = 12 per condition). The SPIN audits indicated that 82% of checklist items were covered, and the WELL audits indicated that 87% were covered. The most common item missed by the coaches across conditions was whether participants visited the websites shared in the newsletters; this will be added to the script for future iterations. Receipt of treatment was measured by discussing completion of the self-monitoring log during all behavioral coaching chats, and enactment of treatment was measured by weekly completion of REDCap data collection forms. Across both conditions and among participants who completed the 16-week assigned condition, 64% of REDCap self-monitoring logs were complete. For SPIN participants, we accessed fitness tracker data via Fitabase (Small Steps Labs) as an additional method to assess treatment. Five participants synced the device and logged at least 1 exercise session, with a range of 18 to 123 exercise bouts logged.
Acceptability
Postintervention satisfaction surveys and qualitative interviews revealed high levels of acceptability (Table 3). SPIN and WELL participants reported an average satisfaction rating of 4.5 and 4.6 out of 5, respectively.
RQA was completed with transcripts from 17 participants (SPIN n = 9; WELL n = 8) who completed postintervention interviews. The mean (SD) length of interviews was 18 (11) minutes. The key themes aligned with constructs from SCT and specific feedback for modifying the SPIN intervention in the future. Participants in both conditions highlighted the importance of structured content delivery, regular coaching interactions, and the online format as key facilitators. SPIN participants expressed that the program’s consistent schedule and personalized coaching helped strengthen intrinsic motivation. The one-on-one coaching fostered a sense of connection and support, enhancing their self-efficacy in maintaining the exercise prescription throughout the program. SPIN participants reported some barriers, such as external conditions and difficulty setting up equipment, which were often framed as management challenges rather than deterrents. Despite these obstacles, SPIN participants consistently reported positive experiences and noted improved symptom management, energy levels, and overall well-being. WELL participants reported similar themes of benefit and engagement, and noted barriers such as goal tracking, technology navigation, and habit formation. WELL participants expressed appreciation for the relevance of wellness topics and the reflective space provided by the coaching team.
Participants offered suggestions for future research that included MS-specific topics such as symptom tracking and mobility support. Others advocated for greater integration of support systems as well as a focus on various health behaviors (eg, hydration and meditation) and emerging MS treatments. Of note, SPIN participants highlighted an interest in many topics covered within WELL, such as diet and fatigue, and WELL participants expressed an interest in exercise.
Overall, the programs were perceived as beneficial, personalized, and well-aligned with the needs of individuals living with MS who use wheelchairs for mobility. One SPIN participant reflected, “It was a wonderful experience. It got me to think and move a lot better.... I really enjoyed it.” A WELL participant similarly shared, “I thought it was terrific...because each of the topics [was] relevant, and I didn’t realize how relevant they were to my lifestyle until I actually explored them with the coaching staff.”
Preliminary Efficacy Outcomes
The ITT analyses on the full sample (n = 23) indicated no significant group × time interactions in scientific outcomes of interest. Among the 20 participants who completed the study (SPIN, n = 10; WELL, n = 10), various factors prevented collecting data on specific measures, which led to differences in sample size between outcomes noted in Table 4. Five participants were unable to complete both blood sample collections, 5 did not return accelerometers for at least 1 assessment, 1 participant did not have any valid days for the first accelerometry measurement and did not complete postintervention questionnaires, and 1 participant had not fasted for the postintervention blood sample assessment. There were no significant group × time interactions on scientific outcomes of interest among the completers. Means (SDs) for all scientific outcomes of interest with effect sizes are presented in Table 4 for the completer analysis; these effect sizes are intended to inform sample size estimates for a future trial, and ITT results were similar.
Follow-up analyses were completed for assessing the proportion of participants per condition who completed the assigned condition that met the 0.5 or more SD baseline improvement guideline for meaningful change. Among SPIN participants, 50% of participants achieved meaningful change in high-density lipoprotein cholesterol, GLTEQ total score, and HADS-D (depression), whereas among WELL participants the only outcome where 50% or more of participants reached this benchmark was HADS-D. The effect size for change on the ActiGraph vector magnitude was –0.67 and was –0.63 on the HADS-A (anxiety), indicating medium effect sizes for device-measured physical activity and anxiety symptoms.
Discussion
The current study examined the feasibility of an adapted, home-based exercise training intervention for people with MS who use wheelchairs. The a priori recruitment and retention benchmarks were achieved, as was evidence for safety of the study protocol. Participants reported high satisfaction ratings across conditions, and there were positive signals regarding improvements in secondary outcomes. Our results support the next step of a larger study that examines the clinically meaningful change in scientific outcomes of interest. This study focused on feasibility as it was the first test of a novel exercise training intervention for people with MS who use wheelchairs. There were positive indications for process feasibility metrics, specifically recruitment rates and ease of randomization, which are key benchmarks for a larger study.25 Success in resource feasibility metrics included participant retention, appropriateness of eligibility criteria, limited barriers to participation, strong compliance with study protocol, and reasonable cost for exercise equipment. Areas for improvement in future studies involve considering use of mobile phlebotomy to mitigate transportation-related barriers and a validated tool to assess physical activity status such as the GLTEQ Health Contribution Score. Feasibility as measured by monitoring fidelity and assessing data management revealed that no problems were encountered. Fidelity monitoring was grounded in the NIH BCC recommendations for study design, provider training, delivery of treatment, receipt of treatment, and enactment of treatment (Table 1).22 We report strong overall results for protocols related to study design and provider training. Regarding provider training, our team created and tested a behavioral coach training protocol that can be utilized in future research. The intervention was delivered with high fidelity, as documented through auditing procedures and implementation checklists, and is consistent with fidelity results in a recently completed phase 3 telehealth physical activity trial in people with MS.26,27 Intervention receipt was monitored and addressed through behavioral coaching calls; participants recieved all coaching call content across conditions. Fitness tracker use was inconsistent, as some participants were less adherent, which represents an opportunity for improvement in future research. Enactment of treatment measurement via devices was indicated among the 5 participants who used them. Future trials should develop protocols to support those who are not recording exercise bouts on the tracking devices or should select devices that automatically detect exercise behavior. Collectively, we report strong results regarding the feasibility of the SPIN intervention protocol.
Acceptability is a key component for participant uptake and engagement in behavioral interventions. These study findings support the strong acceptability of the SPIN intervention. Participants consistently reported that the program was feasible to integrate into their daily routines, even when facing common setbacks such as fatigue and unexpected situations like urgent family matters. Many participants expressed their intention to maintain exercise behaviors after the study, citing improvements in physical health, energy levels, and overall well-being as primary motivators. This provides ongoing evidence that supportive accountability is key for health behavior change and underscores the need to better understand the utility of one-on-one coaching given the challenges of community-wide dissemination with such models.28
One primary lesson learned was the occurrence of nonrelated AEs that are common in people who use wheelchairs and have disabilities such as MS.29,30 The need for additional research on the incidence and management of health-related AEs such as urinary tract infections and falls was highlighted in the final report from the NIH’s Pathways to Prevention (P2P) program “Can Physical Activity Improve the Health of Wheelchair Users?”31 Secondary health conditions, infections, and accidents are more common in this population and may support the need for longer-duration interventions that provide time for disruptions and direct behavioral support through events. The study's SCT-based newsletters include topics such as navigating setbacks that provide opportunities to discuss these topics, but direct support for navigating such challenges may be valuable. Collectively, participants were able to continue the exercise training program following AEs and reported plans for continuing aerobic and resistance training beyond study completion.
This study was not powered to assess efficacy outcomes. There was a positive indication among SPIN participants for change in self-reported exercise behavior, and self-monitoring log completion suggests adherence with the exercise training program. We had a specific interest in meaningful change in metabolic health outcomes given gaps highlighted from the aforementioned NIH P2P workshop that likely require a longer study duration.32,33 Future studies may consider focal assessment on compliance with the exercise training prescription using self-report or devices given there has been an influx of commercially available devices that have algorithms for assessing wheelchair activity including the Apple Watch and several Garmin devices. There are currently no validated cut points for assessment of physical activity among people with MS who use power and manual wheelchairs, which limits our ability to rigorously assess accelerometer data.
Strengths and Limitations
The current study had several strengths, namely the randomized controlled design in a feasibility phase for gathering information that will optimize a fully powered efficacy trial. Despite 2 prior pilot clinical trials in people with MS who use wheelchairs,34,35 the absence of fully powered exercise training studies highlights a critical gap in the existing literature. The participants provided significant feedback to improve future iterations of the intervention and had a strong interest in health promotion research. The current study met recruitment goals, but approximately 30% of those contacted did not respond and 40% were ineligible or no longer interested. We ultimately enrolled 30% of those who reached out. Notably, 60% of individuals screened were enrolled in the clinical trial, which aligns with common rates in exercise clinical trials and should inform considerations for sample size calculations in future clinical trials.36-38 Two primary weaknesses worth noting include the lack of power to assess efficacy of the SPIN intervention and that participants were primarily from the greater Houston area, so the findings may not be broadly applicable.
Conclusions
The current study represents the first clinical trial supporting the feasibility of a home-based exercise training intervention for people with MS who use wheelchairs. Further evidence is needed regarding the impact of the SPIN intervention on scientific outcomes of interest. A future study could have implications for the exercise in medicine research agenda and support overall health and well-being among this understudied population that could significantly benefit from exercise training as a supportive therapy