Multiple Sclerosis (MS)NCT06270641
Increasing Physical Activity for Adults With Multiple Sclerosis (MS)
A study testing ExerciseRx intervention in people with Multiple Sclerosis (MS) and Fatigue, run by University of Washington at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis (MS), Fatigue, Physical Inactivity
- What is being tested?
- ExerciseRx intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UW Medicine
Seattle, Washington, 98133
Laurie Kavanagh, MPH, 206-668-4168, lauriek@uw.edu
About this study
Official title: Increasing Physical Activity Via Provider Prescription and Engagement: Efficacy of ExerciseRx for Adults With Multiple Sclerosis (MS)
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).
Read the 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.
- Conditions
- Multiple Sclerosis (MS), Fatigue, Physical Inactivity
- Being tested
- ExerciseRx intervention
- Medical subject headings
- Multiple Sclerosis, Fatigue, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseRx interventionOther
Also called Exercise Intervention, Best Practice, App-Based Intervention, Interview
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention ExerciseRx-MS | Experimental | 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. Receives: Other: ExerciseRx intervention |
| Usual care | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 13
Secondary outcomes (10)
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.
Measured: Baseline, weeks 13 and 26
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.
Measured: Baseline, weeks 13 and 26
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.
Measured: Baseline, weeks 13 and 26
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.
Measured: Baseline, weeks 13 and 26
Depressive symptom severity - PROMIS Depression Short Form 8a
8-item PROMIS depression questionnaire related to depressed mood in the past 7 days. Each question is rated on a five-point scale from 1=Never to 5=Always. Compared between the ExerciseRx and usual care participants.
Measured: Baseline, weeks 13 and 26
Sleep disturbance - PROMIS Sleep Disturbance Short Form 6a
6 items assessing sleep disturbance. Each question is answered with a score of 1-5 (varies). The raw score is the sum of each item and ranges from 6-30. The raw score is converted to a T-score ranging from 31.7 to 76.1, with a standard deviation of 10. Higher T-scores indicate greater sleep disturbance. Compared between the ExerciseRx and usual care participants.
Measured: Baseline, weeks 13 and 26
Physical functioning - PROMIS Physical Function 10a
10-item questionnaire assessing current self-reported physical function. Raw scores range from 10 to 50 and can be translated into T-scores, with a mean of 50 and a standard deviation of 10, for comparison with the U.S. general population mean; for this study, all reported PF-10a scores are T-scores. A higher T-score represents better physical function. Compared between the ExerciseRx and usual care participants.
Measured: Baseline, weeks 13 and 26
Pain interference - PROMIS Pain Interference Scale Short Form 6a
6-item questionnaire examining the impact of pain on valued areas of an individual's life (e.g., how much did pain interfere with your day to day activities) on a scale of 1=Not at all to 5=Very much. Higher results mean higher interference of pain. Compared between the ExerciseRx and usual care participants.
Measured: Baseline, weeks 13 and 26
Social participation - PROMIS Satisfaction with Social Roles and Activities Short Form 8a
8-item questionnaire assessing satisfaction with performing one's usual social roles and activities. Each question has five response options on a scale of 1=Not at all to 5=Very much. Sum the values of the response to each question to find the total raw score. Compared between the ExerciseRx and usual care participants.
Measured: Baseline, weeks 13 and 26
Social participation - PROMIS Ability to Participate in Social Roles and Activities Short Form 8a
8-item questionnaire assessing the perceived ability to perform one's usual social roles and activities. Items are worded negatively in terms of perceived limitations with responses reverse-coded so that higher scores represent fewer limitations (better abilities). The item bank does not use a time frame (e.g. over the past seven days) when assessing ability to participate in social roles and activities. Each question has five response options on a scale of 1=Never to 5=Always. Compared between the ExerciseRx and usual care participants.
Measured: Baseline, weeks 13 and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start16 Feb 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawn Ehde, University of Washington
- Investigators
- Dawn Ehde, PhD, Principal investigator, UW Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270641
- Sponsor's protocol ID
- STUDY00018628
- Status last verified
- Feb 2024
- First submitted
- 19 Jan 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ehde DM, Simmons SB, Alschuler KN, Herring TE, Humbert AT, Robles SR, Ioseliani O, Landis K, Kavanagh LB, Lin CY. Increasing Physical Activity via Provider Support and Engagement Using a Digital Health Platform in Adults With Multiple Sclerosis: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Nov 21;14:e72213. doi: 10.2196/72213.
PubMed 41268963
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Physical Activity Via Provider Prescription and Engagement: Efficacy of ExerciseRx for Adults With Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT06270641
- Acronym / sponsor ID
- STUDY00018628
- Conditions
- Multiple Sclerosis (MS), Fatigue, Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 16 Feb 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention ExerciseRx-MS | Experimental | Other: ExerciseRx interventionParticipants 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. |
| Usual care | No 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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+
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseRx interventionAlso: Exercise Intervention, Best Practice, App-Based Intervention, InterviewExerciseRx 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. | Other | Intervention ExerciseRx-MS |
Primary outcome
Physical activity: daily average step count
Time frame: Baseline and week 13
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.
10 secondary outcomes
Activity volume
Time frame: Baseline, weeks 13 and 26
Minutes/week of moderate intensity aerobic activity
Time frame: Baseline, weeks 13 and 26
Fatigue - PROMIS Fatigue-MS Short Form 8a
Time frame: Baseline, weeks 13 and 26
Pain intensity - PROMIS Pain Intensity Short Form 3a
Time frame: Baseline, weeks 13 and 26
Depressive symptom severity - PROMIS Depression Short Form 8a
Time frame: Baseline, weeks 13 and 26
Sleep disturbance - PROMIS Sleep Disturbance Short Form 6a
Time frame: Baseline, weeks 13 and 26
Physical functioning - PROMIS Physical Function 10a
Time frame: Baseline, weeks 13 and 26
Pain interference - PROMIS Pain Interference Scale Short Form 6a
Time frame: Baseline, weeks 13 and 26
Social participation - PROMIS Satisfaction with Social Roles and Activities Short Form 8a
Time frame: Baseline, weeks 13 and 26
Social participation - PROMIS Ability to Participate in Social Roles and Activities Short Form 8a
Time frame: Baseline, weeks 13 and 26
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Derived from this study: PubMed 41268963Ehde DM, Simmons SB, Alschuler KN, Herring TE, Humbert AT, Robles SR, Ioseliani O, Landis K, Kavanagh LB, Lin CY. Increasing Physical Activity via Provider Support and Engagement Using a Digital Health Platform in Adults With Multiple Sclerosis: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Nov 21;14:e72213. doi: 10.2196/72213.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Ehde, PhD principal investigator
UW Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExerciseRx intervention in people with Multiple Sclerosis (MS) and Fatigue, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurie Kavanagh, MPH (206-668-4168, lauriek@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity: daily average step count (time frame: Baseline and week 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06270641, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.