Clinical trial NCT06270641: Increasing Physical Activity for Adults With Multiple Sclerosis (MS)
Official title: Increasing Physical Activity Via Provider Prescription and Engagement: Efficacy of ExerciseRx for Adults With Multiple Sclerosis (MS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis (MS)
Fatigue
Physical Inactivity
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Physical activity: daily average step count
timeFrame: Baseline and week 13
Secondary outcomes:
measure: Activity volume
timeFrame: Baseline, weeks 13 and 26
measure: Minutes/week of moderate intensity aerobic activity
timeFrame: Baseline, weeks 13 and 26
measure: Fatigue - PROMIS Fatigue-MS Short Form 8a
timeFrame: Baseline, weeks 13 and 26
measure: Pain intensity - PROMIS Pain Intensity Short Form 3a
timeFrame: Baseline, weeks 13 and 26
measure: Depressive symptom severity - PROMIS Depression Short Form 8a
timeFrame: Baseline, weeks 13 and 26
measure: Sleep disturbance - PROMIS Sleep Disturbance Short Form 6a
timeFrame: Baseline, weeks 13 and 26
measure: Physical functioning - PROMIS Physical Function 10a
timeFrame: Baseline, weeks 13 and 26
measure: Pain interference - PROMIS Pain Interference Scale Short Form 6a
timeFrame: Baseline, weeks 13 and 26
measure: Social participation - PROMIS Satisfaction with Social Roles and Activities Short Form 8a
timeFrame: Baseline, weeks 13 and 26
measure: Social participation - PROMIS Ability to Participate in Social Roles and Activities Short Form 8a
timeFrame: Baseline, weeks 13 and 26
Other outcomes:
Locations:
city: Seattle
country: United States
facility: UW Medicine
state: Washington
Study officials:
affiliation: UW Medicine
name: Dawn Ehde, PhD
role: PRINCIPAL_INVESTIGATOR
References: