Increasing Physical Activity for Adults With Multiple Sclerosis (MS)

NCT ID: NCT06270641

Last Updated: 2024-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-16

Study Completion Date

2026-09-30

Brief Summary

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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).

Detailed Description

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This study aims to test the efficacy of ExerciseRx, a free software platform designed to increase physical activity in people with multiple sclerosis (PwMS). Exercise is crucial for managing MS symptoms and overall health, but approximately 80% of PwMS do not get enough physical activity due to barriers like physical limitations, common MS symptoms, and lack of community exercise facilities. ExerciseRx translates clinically relevant activity data collected by personal smart devices into actionable metrics on a dashboard within the Epic electronic health record, allowing healthcare providers to prescribe and monitor tailored physical activity solutions for their patients. This study will test the effects of ExerciseRx in a sample of inactive PwMS.

Conditions

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Multiple Sclerosis (MS) Fatigue Physical Inactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

ExerciseRx intervention

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Exercise Intervention Best Practice App-Based Intervention Interview Questionnaire Administration

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Dawn Ehde

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dawn Ehde, PhD

Role: PRINCIPAL_INVESTIGATOR

UW Medicine

Locations

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UW Medicine

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Laurie Kavanagh, MPH

Role: CONTACT

206-668-4168

Facility Contacts

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Laurie Kavanagh, MPH

Role: primary

206-668-4168

Other Identifiers

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STUDY00018628

Identifier Type: -

Identifier Source: org_study_id

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