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Behavioural Intervention
Exercise Intervention for Multiple Sclerosis
N/A
Recruiting
Led By Dawn Ehde, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 13 and 26
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test if a phone app can help patients with multiple sclerosis who don't exercise much to become more active.
Who is the study for?
This trial is for adults over 18 with Multiple Sclerosis who can walk without help but are not very active (less than 150 minutes of exercise per week). They must have an iPhone or Android phone to use the study app and cannot be at high risk of falling or have other conditions that make exercising unsafe.
What is being tested?
The study tests a phone-based app called ExerciseRx designed to increase physical activity in people with MS. Participants will use this app, which aims to promote more movement through personalized guidance and tracking.
What are the potential side effects?
Since the intervention involves increased physical activity, potential side effects may include muscle soreness, fatigue, and an increased risk of falls for those predisposed. However, individuals at higher fall risk are excluded from the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, weeks 13 and 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 13 and 26
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Physical activity: daily average step count
Secondary study objectives
Activity volume
Depressive symptom severity - PROMIS Depression Short Form 8a
Fatigue - PROMIS Fatigue-MS Short Form 8a
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ExerciseRx-MSExperimental Treatment1 Intervention
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 II: Usual careActive Control1 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.
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Who is running the clinical trial?
University of WashingtonLead Sponsor
1,829 Previous Clinical Trials
1,906,988 Total Patients Enrolled
Dawn Ehde, PhDPrincipal InvestigatorUW Medicine
3 Previous Clinical Trials
447 Total Patients Enrolled