Increasing Physical Activity for Adults With Multiple Sclerosis (MS)

NCT06270641 | Recruiting

• 1 other identifier: STUDY00018628
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to advance the scientific understanding and potential future implementation of physical activity promotion by testing the efficacy of a phone-based app for increasing activity in insufficiently active patients with multiple sclerosis (MS).

Conditions

Multiple Sclerosis (MS); Fatigue; Physical Inactivity

Outcome Measures

Primary Outcomes (1)

• Physical activity: daily average step count

  Increase in physical activity measured by daily average step count measured by ExerciseRx app. Increase in physical activity will be measured and compared between the ExerciseRx and usual care participants.

  Baseline and week 13

Secondary Outcomes (10)

• Activity volume

  Baseline, weeks 13 and 26

• Minutes/week of moderate intensity aerobic activity

  Baseline, weeks 13 and 26

• Fatigue - PROMIS Fatigue-MS Short Form 8a

  Baseline, weeks 13 and 26

• Pain intensity - PROMIS Pain Intensity Short Form 3a

  Baseline, weeks 13 and 26

• Depressive symptom severity - PROMIS Depression Short Form 8a

  Baseline, weeks 13 and 26

Study Arms (2)

Intervention ExerciseRx-MS

EXPERIMENTAL

Participants use the ExerciseRx app to meet personalized daily step targets and weekly goals. They will receive MS Exercise and Physical Activity Recommendations and complete in-app surveys about barriers to being active and physical activity level. The ExerciseRx app will adjust the personalized step count goals based on percentage met of the previous week goal and providers will send supportive messages based on participant activity. Participants will complete validated self-report assessments. Providers may also provide participants with additional guidance, make referrals, or schedule telemedicine or in-person clinic follow ups if needed to support the participant's physical activity progression.

Other: ExerciseRx intervention

Usual care

NO INTERVENTION

Participants receive MS Exercise and Physical Activity Recommendations, will continue typical physical activity, and complete validated self-report assessments. At the end of 26 weeks, staff will offer the participants the ExerciseRx intervention protocol.

Interventions

ExerciseRx intervention OTHER

ExerciseRx is a cloud-based, HIPPA-compliant free software platform created for healthcare providers to prescribe and monitor physical activity as part of routine care. ExerciseRx translates clinically relevant activity data collected by the patient's existing personal smart devices (Android or iOS phone) into actionable metrics on a dashboard within the Epic electronic health record. Providers then use the platform to prescribe physical activity tailored to patients' ability levels and preferences. The platform incorporates behavior change strategies, including motivational feedback and nudges. It also facilitates a feedback loop with the provider, fostering caring patient-provider connections around activity promotion and behavior change. ExerciseRx leverages patients' personal smartphone capabilities to track, quantify, and tailor personalized physical activity solutions, which makes it more readily scalable as a solution across diverse patient populations.

Also known as: Exercise Intervention, Best Practice, App-Based Intervention, Interview, Questionnaire Administration

Intervention ExerciseRx-MS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provider-confirmed diagnosis of MS using revised 2017 McDonald criteria
• \> 18+ years of age
• Patient determined disease steps (PDDS) score \< 3, indicating the potential for some gait disability although typically ambulates without an assistive device
• Insufficiently active, defined as \< 150 minutes of physical activity per week, assessed using the PAVS in the EHR in clinics as part of the routine patient intake process
• Use of an iPhone with software version iOS13+ or an Android phone 4.1+
• Agree to install and use the ExerciseRx app for the entire study period and keep their phone on them during the daytime (e.g., pocket, bags, hands)

You may not qualify if:

• Recent (past 4 weeks) or planned surgery during the study period which may impact engaging in step counts
• MS relapse within the last 30 days
• Plans to travel internationally during the study period, which could interfere with server uploads of mobile phone data
• Those at a higher risk of falling or injury from falls or unable to safely exercise due to other medical conditions (e.g. heart conditions, diabetes or conditions made worse by walking or physical activity)

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

UW Medicine

Seattle, Washington, 98133, United States

RECRUITING

Related Publications (1)

• Ehde DM, Simmons SB, Alschuler KN, Herring TE, Humbert AT, Robles SR, Ioseliani O, Landis K, Kavanagh LB, Lin CY. Increasing Physical Activity via Provider Support and Engagement Using a Digital Health Platform in Adults With Multiple Sclerosis: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Nov 21;14:e72213. doi: 10.2196/72213.

  PMID: 41268963 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue; Sedentary Behavior

Interventions

Practice Guidelines as Topic; Interviews as Topic

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Dawn Ehde, PhD

  UW Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurie Kavanagh, MPH

CONTACT

206-668-4168; lauriek@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 21, 2024
• Study Start: February 16, 2024
• Primary Completion: April 30, 2025
• Study Completion: September 30, 2026
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)