Exercise Intervention for Multiple Sclerosis

Overseen By Laurie Kavanagh, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

106 Participants Needed

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 can walk without help but may have some difficulty.

Provider-confirmed diagnosis of MS using revised 2017 McDonald criteria

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.

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

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.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Findings from Research

Recent studies indicate that physical exercise programs are safe and effective for improving various physiological functions in patients with multiple sclerosis (MS).

Implementing exercise in rehabilitation strategies can lead to functional improvements that positively impact the daily lives of MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Training for and participating in a unique expedition led to a significant reduction in motor fatigue among participants with multiple sclerosis, particularly those with mild disability, indicating potential benefits of physical activity in this population.

Despite some minor medical events reported, no major adverse events occurred, suggesting that the expedition was safe for participants with MS, especially those without cardiovascular risk factors.

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]

Exercise and physical activity have been shown to provide various benefits for individuals with multiple sclerosis (MS), including improvements in immune function, brain health, walking ability, cognitive performance, fatigue, depression, pain, and overall quality of life.

Despite the positive effects, there is significant variability in the outcomes of exercise interventions for MS, highlighting the need for better-designed studies and a focus on challenges in implementing effective exercise programs.

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]

A systematic review of 81 articles identified 235 different outcomes related to exercise training in multiple sclerosis (MS), highlighting the complexity of measuring exercise effects in this population.

Most outcomes were linked to body functions and activities, with very few addressing body structures or environmental factors, indicating gaps in the current research framework that need to be addressed for comprehensive assessment.

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]

The Multiple Sclerosis Tailored Exercise Program (MSTEP) is being tested in a one-year randomized controlled trial with 240 participants to determine if it leads to greater improvements in exercise capacity and related health outcomes compared to general exercise guidelines.

The study aims to address unique barriers to exercise for people with MS, focusing on outcomes like functional ambulation, strength, and quality of life, which are crucial for managing the disease effectively.

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]

A systematic review of 26 randomized controlled trials involving 1295 participants found that exercise training in individuals with multiple sclerosis (MS) did not increase the risk of relapse, with a relapse rate of 4.6% for exercise compared to 6.3% for control.

The study also reported that the rate of adverse events (AEs) was similar between exercise (2.0%) and control (1.2%) groups, indicating that exercise training is generally safe and does not pose a higher risk of AEs compared to healthy populations.

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]

A systematic review of 40 randomized controlled trials involving 1780 participants found that exercise training does not increase the risk of clinical relapse or adverse events in individuals with multiple sclerosis, suggesting it is a safe intervention.

The analysis showed no significant differences in the rates of relapse, adverse events, or serious adverse events between exercise training and non-exercise groups, supporting the promotion of exercise as a beneficial activity for people with MS.

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]

Exercise has been shown to provide significant benefits for individuals with multiple sclerosis (MS), improving both physical function and quality of life, as supported by recent meta-analyses and literature reviews.

The chapter emphasizes that exercise is safe for people with MS, and it provides guidelines for how to effectively prescribe exercise to maximize these benefits while ensuring safety.

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]

Exercise is a safe and well-tolerated intervention that can effectively improve modifiable impairments in individuals with multiple sclerosis (MS).

Properly prescribed exercise programs, following general guidelines, can enhance the management of MS, particularly for those with more severe symptoms.

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]