Increasing Physical Activity for Adults With Multiple Sclerosis (MS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
ExerciseRx intervention
Other interventionExerciseRx 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.
Treatment groups
106 Participants
are divided into 2 treatment groupsGroup A: Intervention ExerciseRx-MSExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline and week 13Secondary outcomes
1
Activity volume
Increase in activity volume will be measured by International Physical Activity Questionnaire-Short. Increase in activity volume will be measured by the total metabolic equivalent minutes of activity per week using the International Physical Activity Questionnaire-Short and compared between the ExerciseRx and usual care participants.
Time frame
Baseline, weeks 13 and 262
Minutes/week of moderate intensity aerobic activity
Measured using Physical Activity Vital Sign (PAVS), 2 items assessing the number of minutes per week a participant engages in moderate to strenuous intensity activity. Will determine the percentage of participants in each group that meet current activity guidelines of \>150min/week of moderate to strenuous physical activity. Total minutes per week of physical activity (#1 multiplied by #2). Increase in minutes/week of moderate intensity aerobic activity will be measured by PAVS and compared between the ExerciseRx and usual care participants.
Time frame
Baseline, weeks 13 and 263
Fatigue - PROMIS Fatigue-MS Short Form 8a
8 items assessing fatigue scored on a T-score metric, with a mean of 50 and a standard deviation (SD) of 10; higher scores indicate higher fatigue. The T-score metric is referenced to the US general population, e.g. a T-score of 40 would be one SD below the US general population. Compared between the ExerciseRx and usual care participants.
Time frame
Baseline, weeks 13 and 264
Pain intensity - PROMIS Pain Intensity Short Form 3a
3 items assessing pain intensity over the past seven days. A 5-point (from 1= Had no pain to 5= Very severe) rating scale is used in each of the 3 items. Higher results mean higher intensity of pain. Compared between the ExerciseRx and usual care participants.
Time frame
Baseline, weeks 13 and 26Sponsors and contacts
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Source ClinicalTrials.gov