Recruiting

Physical Activity

Sponsor:

University of Washington

Code:

NCT06270641

Conditions

Multiple Sclerosis (MS)

Fatigue

Physical Inactivity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

ExerciseRx intervention

Study Details

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

Study ID

NCT06270641

Start date

Feb 16, 2024

Status verified date

Feb, 2024

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Apr 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Study Design

Enrollment

106 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention ExerciseRx-MS

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.

no intervention: Usual care

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

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.

Primary outcome measure

  • Physical activity: daily average step count [ Time Frame: Baseline and week 13 ]

Central Contacts and Locations

Central contacts

Laurie Kavanagh, MPH

206-668-4168lauriek@uw.edu

Locations

UW Medicine

Recruiting

Seattle, Washington, United States, 98133

Contacts

Laurie Kavanagh, MPH

206-668-4168lauriek@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Feb 22, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2024-02-22.