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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a phone app can help people with multiple sclerosis (MS) become more active. Participants will either maintain their usual routine or use the ExerciseRx app, an exercise intervention, to track and increase their daily steps and weekly exercise goals. The app aims to boost activity levels through personalized goals and support messages. Individuals with MS who currently exercise less than 150 minutes per week and can walk unaided might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance daily life for those with 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 prior data suggests that this app-based exercise intervention is safe for individuals with multiple sclerosis?

Research has shown that exercise programs for people with multiple sclerosis (MS) are generally safe. Studies have found that exercise does not increase the risk of MS flare-ups and is an effective way to aid recovery. Current evidence supports that exercise is not only safe but also beneficial for those with MS.

Participants using the ExerciseRx app receive support to meet personalized daily step targets and weekly goals. This method was tested and found safe for increasing physical activity in adults with MS. Overall, exercise programs like this are well-tolerated and do not pose significant safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for multiple sclerosis (MS) that often focus on medications to manage symptoms, the ExerciseRx intervention is all about personalized physical activity. Researchers are excited because it uses an app to tailor daily step goals and weekly targets based on individual progress, making it a highly customized approach. This method encourages engagement through feedback and support from providers, which could lead to better adherence and outcomes. It's a novel way of integrating technology with personal health goals, offering a fresh perspective in managing MS through lifestyle changes rather than just medication.

What evidence suggests that the ExerciseRx intervention is effective for increasing physical activity in multiple sclerosis patients?

Research shows that exercise programs are safe and effective for enhancing physical abilities in people with multiple sclerosis (MS). Studies indicate that exercise can lead to lasting improvements in both physical and social activities for those with MS. Evidence suggests that different exercise plans can help in various ways, depending on individual goals. In this trial, participants in the ExerciseRx-MS arm will use the ExerciseRx app to reach personal activity targets and encourage more physical activity. With support from healthcare providers, this approach may help people with MS start and maintain regular exercise habits. Meanwhile, participants in the usual care arm will receive MS Exercise and Physical Activity Recommendations and continue their typical physical activity. ^{1 2 3 4 6}

Who Is on the Research Team?

Dawn Ehde, PhD

Principal Investigator

UW Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

Citations

1.

withpower.com

withpower.com/trial/phase-fatigue-1-2024-2f3f3

Exercise Intervention for Multiple Sclerosis

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

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5602953/

Exercise prescription for patients with multiple sclerosis

The results of several studies on patients with MS confirm the effectiveness of exercise on long period improvement in physical and social ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02297932

Physical Activity in Multiple Sclerosis (MS): A Novel ...

To date, the evidence suggests that exercise intervention in MS holds anywhere from minimal to great promise depending on the outcome of interest. For some ...

4.

researchgate.net

researchgate.net/publication/395121233_Protocol_for_a_Randomized_Controlled_Trial_of_Increasing_Physical_Activity_via_Provider_Support_and_Engagement_Using_ExerciseRx_in_Adults_with_Multiple_Sclerosis_Preprint

Protocol for a Randomized Controlled Trial of Increasing ...

Protocol for a Randomized Controlled Trial of Increasing Physical Activity via Provider Support and Engagement Using ExerciseRx in Adults ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06933160

Promotion of Exercise Through Physical Therapy for ...

A proactive physical therapy delivery model may help persons with multiple sclerosis increase and maintain their physical activity and exercise behaviors. The ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2211034825003657

Exercise Training in Multiple Sclerosis: Preparing for ...

Exercise training is safe and highly beneficial for people with multiple sclerosis (MS). •. Physical inactivity and sedentary behavior remain particularly ...