Exercise for Multiple Sclerosis

(FIT-ATOMIC Trial)

Not yet recruiting at 3 trial locations

Overseen By Carmen Yea, MSc

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Non-specific white matter, Motor disability, Cardiac risk, others

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

Compensation: Varies

Number of Visits: 3

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether a 20-week home-based exercise program can help youth with Multiple Sclerosis (MS) improve their physical and mental health. Participants will be split into two groups: one focusing on exercise training and the other on mobility and flexibility. Researchers will compare the effects of each group on physical activity, mood, and cognitive function. The trial seeks young people diagnosed with MS who have experienced symptoms like feeling down or low energy.

As an unphased trial, this study offers a unique opportunity for participants to contribute to understanding how exercise can benefit young people with MS.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It focuses on exercise as a non-drug approach, so it's best to discuss your current medications with the trial coordinators.

What prior data suggests that this exercise intervention is safe for youth with Multiple Sclerosis?

Research shows that exercise is safe for people with multiple sclerosis (MS). Studies have found that those who exercise do not face a higher risk of symptom recurrence or serious side effects compared to those who don't exercise. In fact, some research suggests that exercise might reduce the chance of symptoms returning by about 27%. Additionally, exercise is not only safe but also beneficial, as it can improve fitness and overall well-being. For those considering joining a trial that includes exercise, current evidence supports its safety and potential benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores exercise as a potential way to improve health in people with Multiple Sclerosis (MS). Unlike standard treatments for MS, which often focus on medications to manage symptoms and slow disease progression, this trial investigates how a structured exercise program might enhance physical well-being and quality of life. The unique aspect of this trial is its progressive interval-based training, tailored to individual fitness levels and delivered through live virtual sessions. This personalized approach aims to not only improve fitness but also boost overall mobility and flexibility, offering a holistic benefit beyond what typical MS treatments provide.

What evidence suggests that this trial's exercise interventions could be effective for youth with Multiple Sclerosis?

Research shows that exercise can greatly benefit people with Multiple Sclerosis (MS). Studies have found that exercise improves balance, walking, stamina, and overall quality of life for those with MS. In this trial, researchers will assign participants to different groups to evaluate the effects of exercise. The Exercise Training Group will engage in high-intensity activities, such as aerobic and strength training, which have enhanced balance and posture. Meanwhile, the Mobility & Flexibility Training Group will focus on improving mobility and flexibility. Exercise can also reduce tiredness, a common problem for people with MS. Overall, exercise is considered safe and very helpful for managing MS symptoms. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for young individuals with Multiple Sclerosis. They should be able to perform exercises at home and willing to undergo various assessments, including brain scans and blood tests. Details on specific age or health status requirements are not provided.

Inclusion Criteria

A score of 10 or above on the CES-DC scale.

I am between 11 and 25 years old.

I have been diagnosed with MS or had a single MS-like episode.

Exclusion Criteria

Have non-specific white matter abnormalities and metabolic or infectious etiologies for white matter abnormalities

Do not speak and read English at a level needed to complete the questionnaires (4th grade level)

Are at increased risk of cardiac or other complications of exercise testing, as determined by the pediatric neurologist or physician

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessments including clinical exams, brain MRI, MEG/eye tracking, cognitive testing, blood draws, and questionnaires

1 week

1 visit (in-person)

Treatment

Participants engage in a 20-week home-based exercise program or a mobility and flexibility training program

20 weeks

Weekly virtual sessions

Midpoint Assessment

Accelerometry and other assessments to track progress at 10 weeks

1 week

1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including final assessments

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Training Intervention
• Mobility and Flexibility Training

Trial Overview

The study is testing a 20-week home-based exercise program against a control group doing mobility and flexibility training. It aims to see if the exercise program can improve physical activity levels, mental health, cognitive function, and biological markers in youth with MS.

How Is the Trial Designed?

Group I: Exercise Training Group Active Control 1 Intervention

The exercise training will follow a progressive interval-based training program designed for youth with MS. Participants will engage in three weekly exercise sessions. Participants will be given access to links to live virtual structured exercise sessions. The sessions will be scheduled weekly in partnership with a coach. A trained fitness instructor will lead the participants in a 10-minute warm-up, followed by 30 minutes of interval training, and a 10-minute stretching and cool down activity. Intervals will progress in intensity over the course of the 20-week program and progression will be based on individualized target heart rate zones established from baseline exercise testing.

Group II: Mobility & Flexibility Training Group Placebo Group 1 Intervention

The Mobility \& Flexibility Training Program focuses on mobility and flexibility. The training will be focused on improving mobility and flexibility through three times a week stretching and mobility program. A 5-minute warm up will be followed by a series of stretches and mobility patterns that will be repeated as a circuit four times. Each session will focus on a specific muscle group - upper body, lower body or core. The classes will be led by a fitness instructor in the same manner as the exercise group with a virtual link sent to the participants.

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Alberta Health Services, Calgary

Collaborator

Trials

15

Recruited

2,600+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

Unity Health Toronto

Collaborator

Trials

572

Recruited

470,000+

Queen's University

Collaborator

Trials

382

Recruited

122,000+

National Multiple Sclerosis Society

Collaborator

Trials

100

Recruited

10,600+

Multiple Sclerosis Society of Canada

Collaborator

Trials

17

Recruited

990+

Queen's University

Collaborator

Published Research Related to This Trial

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]

Exercise is an effective behavioral approach for improving function and managing symptoms in individuals with multiple sclerosis (MS), supported by literature reviews and meta-analyses.

The review emphasizes that exercise is generally safe for people with MS, with low reports of relapses and adverse events, and provides guidelines for safe exercise practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits, safety, and prescription of exercise in persons with multiple sclerosis. Motl, RW.[2022]

Recent studies indicate that exercise training can provide significant benefits for individuals with multiple sclerosis (MS), improving fitness, quality of life, and potentially reducing disability.

The review highlights the possible biological mechanisms behind these benefits, such as the role of neurotrophic factors and anti-inflammatory cytokines, suggesting that exercise may have neuroprotective effects in MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise in multiple sclerosis: supportive care or a putative disease-modifying treatment. Heesen, C., Romberg, A., Gold, S., et al.[2022]

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]

A systematic review of 19 studies found that exercise training, particularly adapted modalities like body-weight support treadmill training and electrical stimulation cycling, can lead to significant improvements in mobility, physical fitness, and quality of life for individuals with severe mobility impairment due to multiple sclerosis (MS).

While conventional exercise training showed some benefits, the majority of positive outcomes were associated with adapted exercise approaches, highlighting the need for accessible exercise interventions for people with MS who have high levels of disability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of exercise training in adults with multiple sclerosis with severe mobility disability: A systematic review and future research directions. Edwards, T., Pilutti, LA.[2022]

Exercise training is now widely recommended for managing multiple sclerosis (MS), reflecting over 25 years of research supporting its benefits for individuals with the condition.

The paper highlights eight emerging research areas, such as behavior change interventions and telerehabilitation, that could enhance the effectiveness and implementation of exercise in clinical practice for MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current perspectives on exercise training in the management of multiple sclerosis. Motl, RW., Sandroff, BM.[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]

Exercise training can lead to small but significant improvements in various aspects of life for people with multiple sclerosis (MS), including walking, balance, cognition, fatigue, depression, and overall quality of life.

The review emphasizes the importance of promoting exercise as a key component of clinical care for MS patients, suggesting that healthcare providers, especially neurologists, should actively encourage exercise training based on recent guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of Exercise Training in Multiple Sclerosis. Motl, RW., Sandroff, BM.[2022]

Over a 2.5-year study involving 269 participants with relapsing-remitting multiple sclerosis, significant improvements were observed in both self-reported and objectively measured physical activity, along with self-efficacy and walking impairment.

Changes in physical activity were strongly associated with improvements in self-efficacy, suggesting that enhancing self-confidence may be key to promoting and maintaining physical activity in individuals with multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal change in physical activity and its correlates in relapsing-remitting multiple sclerosis. Motl, RW., McAuley, E., Sandroff, BM.[2022]

A systematic review of 20 randomized controlled trials involving exercise training in individuals with multiple sclerosis showed that exercise significantly improves muscular fitness (small effect size of 0.27) and cardiorespiratory fitness (moderate effect size of 0.47).

The results indicate that while exercise training leads to beneficial changes in fitness levels for people with MS, the improvements in muscular fitness are smaller compared to those in cardiorespiratory fitness, highlighting the importance of exercise in rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Exercise Training on Fitness in Multiple Sclerosis: A Meta-Analysis. Platta, ME., Ensari, I., Motl, RW., et al.[2022]

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 meta-analysis of 17 randomized controlled trials involving 568 participants with multiple sclerosis (MS) found that exercise training leads to a significant small reduction in fatigue, with an effect size of 0.45.

The results indicate that exercise can be an effective intervention for managing fatigue in individuals with MS, providing a potential strategy for improving their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise training on fatigue in multiple sclerosis: a meta-analysis. Pilutti, LA., Greenlee, TA., Motl, RW., et al.[2022]

Exercise therapy is a safe and effective nonpharmacological treatment for people with multiple sclerosis (MS), showing improvements in physical function without increasing the risk of relapses.

In addition to enhancing physical capabilities, exercise therapy positively impacts brain health, leading to improvements in brain volume and cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise therapy in multiple sclerosis and its effects on function and the brain. Dalgas, U.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11039920/

Effects of exercise in people with multiple sclerosis

Exercise had beneficial effects in improving balance, walking ability, walking endurance, fatigue, and quality of life in people with MS.

2.

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 ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37178578/

High intensity exercise training on functional outcomes in ...

This study examined HIT modalities (eg, aerobic, resistance, functional training) on functional outcomes such as walking, balance, postural control, and ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0031940624004139

Exploring the effectiveness of circuit training rehabilitation ...

Circuit training rehabilitation comprising balance and resistance exercises may improve balance and reduce fatigue symptoms in People with Multiple Sclerosis ...

5.

link.springer.com

link.springer.com/article/10.1007/s00415-025-13311-w

Functional exercise training in persons with multiple sclerosis

In the studies that examined mobility, significant improvements were recorded in three studies in favor of the intervention group compared to ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37880997/

Safety of exercise training in multiple sclerosis

In studies that reported safety outcomes, there was no higher risk of relapse, AE, adverse effects or SAE for exercise training than the comparator.

7.

systematicreviewsjournal.biomedcentral.com

systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-021-01751-0

Safety of exercise training in multiple sclerosis: a protocol for ...

That study reported that people with MS receiving a form of exercise intervention had lower rates of relapse equating to approximately 27% lower ...

8.

frontiersin.org

frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1387658/full

Effects of exercise in people with multiple sclerosis

Our results showed that exercise significantly improved walking ability (MSWS-12) and walking endurance (6MWT) in people with MS, which was in agreement with ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11541987/

Advancements and Challenges in Exercise Training for ...

Randomized controlled trials indicate that exercise training is safe and yields substantial benefits from improvements in fitness through ...