Increasing Physical Activity via Provider Support and Engagement Using a Digital Health Platform in Adults With Multiple Sclerosis: Protocol for a Randomized Controlled Trial.

backgroundThe benefits of physical activity are well established in people with multiple sclerosis (MS); yet, most people with MS are insufficiently active. Although many apps and devices are available to promote physical activity, these are not connected to electronic health records (EHRs), making it difficult for health care providers to prescribe and monitor their patients' physical activity. The ExerciseRx platform is an innovative cloud-based, Health Insurance Portability and Accountability Act-compliant software platform (app+provider dashboard) that was developed to bridge the gap between consumer activity tracking devices, such as personal smartphones, and the EHR. The ExerciseRx app tracks a patient's physical activity using their existing personal smartphone and provides a personalized graded progression in step count goals to increase step count gradually and safely over time. The ExerciseRx app also translates the activity data into actionable metrics on a provider dashboard within the EHR that the provider can use to make activity recommendations and monitor patients' progress; they can also support patients by providing semiautomated weekly feedback and encouragement in meeting physical activity goals.

objectiveThis paper describes the protocol for a randomized controlled trial designed to understand whether the ExerciseRx digital health platform improves physical activity, symptoms, and functioning in adults with MS relative to a waitlist, usual care control.

methodsParticipants are ambulatory adults with MS (n=106) who engage in <150 minutes per week of moderate to vigorous intense physical activity. Enrolled participants are assigned to use the ExerciseRx app for 12 weeks, versus a waitlist, usual care control. Participants allocated to the intervention condition have access to the ExerciseRx app, and their providers have access to the participants' activity data via a provider dashboard, connected to the EHR. Participants allocated to usual care receive the care they would normally obtain at the MS Center, including encouragement to participate in and increase physical activity as tolerated from their clinical provider and a handout that describes the current physical activity recommendations for adults with MS and links to local and web-based resources suitable for MS. The primary outcome is the change in average daily step count throughout the 12-week intervention. Secondary outcomes include symptoms (fatigue intensity, pain intensity, sleep, and depressive symptoms), patient-reported functional outcomes (physical functioning, fatigue interference, pain interference, falls, and social participation), and qualitative analysis of participant and provider interviews on usability and acceptability of the ExerciseRx platform.

resultsThe study was funded in October 2023. Participant enrollment began in March 2024 and will continue through December 2025. As of July 25, 2025, a total of 85 participants have been enrolled in the trial. Data analysis and dissemination preparations will begin in January 2026.

conclusionsResults of this trial will provide important new information on the efficacy of an innovative digital health intervention tool for physical activity promotion.

trial registrationClinicalTrials.gov NCT06270641; https://clinicaltrials.gov/study/NCT06270641. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/72213.