Exercise for Multiple Sclerosis

Overseen By Cameron Mang, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Regina

Disqualifiers: High physical activity, Seizure history, Other neurological conditions, Relapse, Psychiatric diagnosis, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 36

Duration: 12 weeks

69 Participants Needed

Trial Summary

What is the purpose of this trial?

A growing body of work suggests that regular exercise can support symptom management and improve physical function for people living with multiple sclerosis (MS). Although exercise is known to be beneficial for managing many symptoms related to MS, its effects on the central nervous system, and whether these effects change with different types of exercise, are not well understood. Here, the investigators have designed a clinical trial that compares the effects of distinct exercise protocols on aspects of physical function, physical fitness, and central nervous system function. This research will be the first to compare the effects of different types of exercise on central nervous system changes in people 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.

What data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training for Multiple Sclerosis?

Research shows that exercise can improve daily life for people with multiple sclerosis by reducing depression and fatigue, enhancing quality of life, and improving physical functions like walking and cognitive performance. ^{1 2 3 4 5}

Is exercise safe for people with multiple sclerosis?

Exercise is generally safe for people with multiple sclerosis. 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. ^{5 6 7 8 9}

How does exercise as a treatment for multiple sclerosis differ from other treatments?

Exercise is a unique treatment for multiple sclerosis because it is a non-drug approach that can improve physical function and brain health without increasing the risk of relapses. Unlike traditional drug therapies, exercise involves physical activity like aerobic and resistance training, which can enhance strength and cognition in a safe and well-tolerated manner. ^{4 10 11 12 13}

Research Team

Cameron Mang, PhD

Principal Investigator

University of Regina

Eligibility Criteria

This trial is for people with progressive multiple sclerosis (MS) who have moderate motor disability and can safely exercise. They should not be highly active already, haven't had an MS relapse in the last three months, and don't have other neurological conditions, psychiatric diagnoses or substance abuse issues.

Inclusion Criteria

My condition is progressive MS, diagnosed by a neurologist.

Physician clearance for exercise

I have moderate difficulty moving around due to my condition.

Exclusion Criteria

Baseline score >24 on the Godin-Shephard Leisure Time Physical Activity Questionnaire (i.e., high physical activity levels)

I have never had a seizure or other reasons I can't have TMS.

Substance abuse

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in one of three distinct exercise programs focusing on mobility, fitness, or flexibility, delivered three times per week in 60-minute group sessions

12 weeks

36 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments conducted immediately before, after, and six weeks following completion of the exercise programs

6 weeks

Treatment Details

Interventions

• Exercise

Trial Overview The study is testing how different types of exercises affect physical function, fitness, and central nervous system changes in individuals with MS. Participants will be assigned to one of three distinct exercise protocols to see which has the most beneficial effects.

Participant Groups

Group I: Exercise Group 1 Experimental Treatment 1 Intervention

The intervention will focus on mobility and balance.

Group II: Exercise Group 2 Active Control 1 Intervention

This intervention will focus on physical fitness.

Group III: Exercise Group 3 Placebo Group 1 Intervention

This intervention will focus on flexibility, range of motion, and muscle tone.

Who Is Running the Clinical Trial?

University of Regina

Lead Sponsor

Trials

59

Recruited

9,100+

First Steps Wellness Centre

Collaborator

Trials

1

Recruited

70+

Saskatchewan Health Research Foundation

Collaborator

Trials

33

Recruited

5,100+

University of Saskatchewan

Collaborator

Trials

261

Recruited

156,000+

Findings from Research

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]

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]

Physical activity has been shown to counteract depression and fatigue in patients with multiple sclerosis (MS), potentially improving their overall quality of life.

Exercise may have an immunomodulatory effect in MS, as it influences the immune system and promotes the release of neurotrophic factors, which could help reduce functional impairment in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Multiple sclerosis and exercise : effects of physical activity on the immune system]. Waschbisch, A., Tallner, A., Pfeifer, K., et al.[2021]

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]

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]

High-intensity resistance training significantly reduced levels of the pro-inflammatory cytokine tumor necrosis factor in patients with relapsing-remitting multiple sclerosis, suggesting a positive impact on immune function.

Participants experienced clinically meaningful improvements in fatigue, health-related quality of life, mood, muscle strength, walking speed, and cognition after 12 weeks of training, indicating that this exercise regimen is both effective and well-tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity resistance training in multiple sclerosis - An exploratory study of effects on immune markers in blood and cerebrospinal fluid, and on mood, fatigue, health-related quality of life, muscle strength, walking and cognition. Kierkegaard, M., Lundberg, IE., Olsson, T., 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 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 six-week resistance training program using bodyweight exercises significantly improved physical fitness in 36 patients with multiple sclerosis, suggesting that strength training can be beneficial for MS sufferers.

This study highlights the importance of incorporating muscular strength development into rehabilitation programs for MS, which have traditionally focused more on aerobic exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a resistance training program in multiple sclerosis Spanish patients: a pilot study. Ayán Pérez, C., Martín Sánchez, V., De Souza Teixeira, F., et al.[2019]

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]

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 10-week exercise program combined with Social Cognitive Theory (SCT) education showed improvements in anxiety, depression, cognition, and the physical impact of multiple sclerosis (MS) for participants in the SCT group, while no significant differences were found between the SCT and attention control groups overall.

Both groups experienced significant improvements in fatigue, strength, and physical activity, which were maintained for 3 to 6 months after the program, indicating that following exercise guidelines can have lasting benefits for individuals with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of exercising at minimum recommendations of the multiple sclerosis exercise guideline combined with structured education or attention control education - secondary results of the step it up randomised controlled trial. Coote, S., Uszynski, M., Herring, MP., et al.[2018]

References

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

Effect of Exercise Training on Fitness in Multiple Sclerosis: A Meta-Analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Physical Exercise and MS Recommendations. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

[Multiple sclerosis and exercise : effects of physical activity on the immune system]. [2021]

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

Current perspectives on exercise training in the management of multiple sclerosis. [2021]

5. 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]

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

High-intensity resistance training in multiple sclerosis - An exploratory study of effects on immune markers in blood and cerebrospinal fluid, and on mood, fatigue, health-related quality of life, muscle strength, walking and cognition. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

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

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

Exercise and Multiple Sclerosis. [2020]

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

Effects of a resistance training program in multiple sclerosis Spanish patients: a pilot study. [2019]

11. England pubmed.ncbi.nlm.nih.gov

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

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

Exercise in multiple sclerosis. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Effect of exercising at minimum recommendations of the multiple sclerosis exercise guideline combined with structured education or attention control education - secondary results of the step it up randomised controlled trial. [2018]