Exercise Intervention for Multiple Sclerosis

Recruiting in Palo Alto (17 mi)

Overseen by Dawn Ehde, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Washington

Disqualifiers: Recent surgery, MS relapse, heart conditions, diabetes, others

No Placebo Group

Trial Summary

What is the purpose of 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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on increasing physical activity for people with multiple sclerosis.

What data supports the effectiveness of the treatment ExerciseRx intervention, Exercise Prescription, Physical Activity Intervention, Exercise Therapy for Multiple Sclerosis?

Research shows that exercise can improve various functions in people with multiple sclerosis (MS), such as reducing fatigue and enhancing walking abilities, which can positively impact daily life. Additionally, exercise has been found to benefit immune function, brain health, and overall quality of life in MS patients. ^{1 2 3 4 5}

Is exercise intervention safe for people with multiple sclerosis?

Exercise interventions for people with multiple sclerosis are generally safe. Studies show that exercise does not increase the risk of relapse and the risk of adverse events (unwanted side effects) is similar to that in healthy populations. ^{6 7 8 9 10}

How does the ExerciseRx treatment differ from other treatments for multiple sclerosis?

ExerciseRx is unique because it focuses on improving physical function and quality of life through tailored exercise programs, which can enhance walking, cognitive performance, and reduce fatigue and depression in people with multiple sclerosis. Unlike medications, this treatment involves physical activity, which is generally safe, well-tolerated, and can be customized to individual needs. ^{1 3 5 8 10}

Research Team

Dawn Ehde, PhD

Principal Investigator

UW Medicine

Eligibility Criteria

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.

Inclusion Criteria

Insufficiently active (< 150 minutes of physical activity per week) assessed using the PAVS in the EHR

I am 18 years old or older.

I can walk without help but may have some difficulty.

Exclusion Criteria

I have had or will have surgery that affects my ability to walk.

I have had an MS flare-up in the last month.

I am at high risk of falling or cannot safely exercise due to a medical condition like heart disease or diabetes.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the ExerciseRx app to meet personalized daily step targets and weekly goals, with provider support and monitoring.

26 weeks

Telemedicine or in-person follow-ups as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at weeks 13 and 26.

4 weeks

Treatment Details

Interventions

• ExerciseRx intervention (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Intervention ExerciseRx-MS Experimental Treatment 1 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 care Active Control 1 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UW Medicine Seattle, WA

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1858

Patients Recruited

2,023,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Exercise and MS Recommendations. Dalgas, U., Ingemann-Hansen, T., Stenager, E.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a 5-day expedition to machu picchu on persons with multiple sclerosis. D'hooghe, MB., Feys, P., Deltour, S., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned from clinical trials of exercise and physical activity in people with MS - guidance for improving the quality of future research. Motl, RW., Fernhall, B., McCully, KK., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The MoxFo initiative - outcomes: Outcome measures in studies of exercise training in multiple sclerosis; scoping review of reviews and classification according to the ICF framework. Ramari, C., Awadia, Z., Bansi, J., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of exercise in modifying outcomes for people with multiple sclerosis: a randomized trial. Mayo, NE., Bayley, M., Duquette, P., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of exercise training in multiple sclerosis: a systematic review. Pilutti, LA., Platta, ME., Motl, RW., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of exercise training in multiple sclerosis: An updated systematic review and meta-analysis. Learmonth, YC., P Herring, M., Russell, DI., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and Multiple Sclerosis. Motl, RW.[2020]

A 12-week telerehabilitation program, called TeleCAM, is being tested on 820 people with multiple sclerosis (MS) to provide accessible exercise and rehabilitation services at home, potentially overcoming barriers faced by those in rural, low-income areas.

The study will evaluate the effectiveness of TeleCAM compared to traditional in-clinic therapy (DirectCAM) by measuring patient-centered health outcomes like pain, fatigue, and quality of life, as well as physical functioning measures, to ensure benefits are realized across diverse demographics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of the tele-exercise and multiple sclerosis (TEAMS) study: A comparative effectiveness trial between a clinic- and home-based telerehabilitation intervention for adults with multiple sclerosis (MS) living in the deep south. Rimmer, JH., Thirumalai, M., Young, HJ., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in multiple sclerosis. Sandoval, AE.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Physical Exercise and MS Recommendations. [2022]

2. Egypt pubmed.ncbi.nlm.nih.gov

Impact of a 5-day expedition to machu picchu on persons with multiple sclerosis. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Lessons learned from clinical trials of exercise and physical activity in people with MS - guidance for improving the quality of future research. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The MoxFo initiative - outcomes: Outcome measures in studies of exercise training in multiple sclerosis; scoping review of reviews and classification according to the ICF framework. [2023]

5. England pubmed.ncbi.nlm.nih.gov

The role of exercise in modifying outcomes for people with multiple sclerosis: a randomized trial. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The safety of exercise training in multiple sclerosis: a systematic review. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Safety of exercise training in multiple sclerosis: An updated systematic review and meta-analysis. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Exercise and Multiple Sclerosis. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Rationale and design of the tele-exercise and multiple sclerosis (TEAMS) study: A comparative effectiveness trial between a clinic- and home-based telerehabilitation intervention for adults with multiple sclerosis (MS) living in the deep south. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Exercise in multiple sclerosis. [2022]