Patient-Centered, Theory-Based, Online Intervention to Promote a Physically Active Lifestyle for People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial (Preprint)

<sec> <title>BACKGROUND</title> People with multiple sclerosis (MS) experience life challenges due to the nature of disease progression. Although an active lifestyle has been shown effective for symptom and relapse management, most people with MS lead a sedentary lifestyle and do not reach the recommended physical activity (PA) guidelines. </sec> <sec> <title>OBJECTIVE</title> This study aims to test the preliminary efficacy of a codeveloped, online self-management intervention based on the health action process approach (HAPA) adapted for people with MS to cultivate a physically active lifestyle. </sec> <sec> <title>METHODS</title> The 8-week intervention program was developed using community-based participatory research based on the HAPA. The program includes increasing awareness of incorporating PA in a daily routine, the benefits of physical activities for people with MS, developing motivation, utilizing social and environmental support, setting measurable goals and doable plans, and coping with barriers for long-term adoption of new behaviors. Community members with MS serve as peer coaches. We aimed to recruit 60 people with MS, randomizing them to an intervention group or a wait-list control group. Control group participants do not receive any intervention nor information for the period of study. Participants will complete PA measures (accelerometer and survey) and psychological assessments at baseline; after an 8-week intervention; and 3 months, 6 months, and 12 months postintervention. We hypothesize that the intervention group will have (1) higher scores on the HAPA questionnaires and (2) higher frequency, duration, and intensity of engagement in PA after the intervention than the control group. We will conduct descriptive analyses (means, SDs), chi-squared tests, independent &lt;i&gt;t&lt;/i&gt; tests, paired &lt;i&gt;t&lt;/i&gt; tests, repeated measures ANOVA, and 2-way (any 2 factors of conditions, disability severity levels, and time) and 3-way (conditions × disability severity levels × time) mixed model ANOVAs. </sec> <sec> <title>RESULTS</title> The study was funded in April 2018 and was delayed due to the COVID-19 pandemic. We invited peer coaches to review the accessibility of online modules in fall 2022. We finalized the module accessibility and trained peer coaches on how to use the online modules in December 2022. Since February 2023, we have recruited 50 participants to the trial who have been assigned to the intervention group (n=25) or control group (n=25). During the follow-up stage, 3 participants dropped out of the intervention group, and 4 participants dropped out of the control group. Enrollment ended in 2024, and data collection is expected to conclude by December 2025, with results anticipated to be published in January 2026. </sec> <sec> <title>CONCLUSIONS</title> This study will test the effectiveness of using an evidence-based online intervention for self-management of physical activity behavior by people with MS. The results of the study will provide us with insightful information for designing community-based participatory research and implementing telerehabilitation interventions for people with MS. </sec> <sec> <title>CLINICALTRIAL</title> ClinicalTrials.gov NCT05124522; https://clinicaltrials.gov/study/NCT05124522 </sec> <sec> <title>INTERNATIONAL REGISTERED REPORT</title> DERR1-10.2196/66091 </sec>