Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 6, 2025
Date Accepted: Aug 31, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Protocol for a Randomized Controlled Trial of Increasing Physical Activity via Provider Support and Engagement Using ExerciseRx in Adults with Multiple Sclerosis
ABSTRACT
Background:
The benefits of physical activity are well-established in people with multiple sclerosis (MS), yet most people with MS are insufficiently active.
Objective:
This article describes the study 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.
Methods:
Participants are ambulatory adults with MS (N = 106) who engage in <150 minutes per week of moderate to vigorous intensity physical activity. Enrolled participants are assigned to 26 weeks of ExerciseRx app use versus a waitlist control. ExerciseRx is a cloud-based, HIPAA-compliant software platform that was created for healthcare providers to support patients in physical activity for wellness. ExerciseRx collects physical activity data from the patient’s personal smartphone and translates it into actionable metrics on a dashboard that can be used within the electronic health records. ExerciseRx personalizes a graded progression in step count goals, and healthcare providers can monitor progress towards these goals and support patients by providing semi-automated weekly feedback and encouragement in meeting physical activity goals. 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 ExerciseRx usability and acceptability.
Results:
Not applicable.
Conclusions:
Results of this trial will provide important new information on the efficacy of an innovative digital health intervention tool for physical activity promotion. Clinical Trial: This clinical trial is registered at ClinicalTrials.gov NCT06270641.
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Copyright
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