Aerobic Exercise for Multiple Sclerosis

Overseen By Lindsey B Wooliscroft, MD, MSc, MCR

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Oregon Health and Science University

Must not be taking: 4-aminopyridine, Dalfampridine, Steroids

Disqualifiers: Pregnancy, Severe spinal stenosis, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether aerobic exercise on a stationary bike can help repair nerve damage in people with multiple sclerosis (MS). Participants will either join a cycling group, exercising three times a week, or an education group that meets monthly to learn about MS. The goal is to determine if exercise alone aids in rebuilding the protective layer around nerves. People diagnosed with MS who do not currently exercise much might be a good fit for this trial. As a Phase 1/Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

If you are taking 4-aminopyridine or dalfampridine, you will need to stop them for 2 days before certain tests. The trial does not specify if you need to stop other medications, so it's best to ask the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that aerobic exercise is safe for people with multiple sclerosis (MS). Studies have found that it can improve balance, walking, and reduce tiredness, enhancing the overall quality of life for those with MS.

In earlier studies, participants handled aerobic exercise programs well. For example, a structured exercise program done twice a week for eight weeks improved participants' mood, and this positive effect lasted for several months.

Overall, aerobic exercise is considered helpful and safe for managing MS symptoms. Participants in past studies did not report major negative effects, suggesting that this type of exercise is generally safe for people with MS. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about aerobic exercise as a treatment for Multiple Sclerosis (MS) because it offers a non-pharmacological approach that could complement or even enhance existing therapies like disease-modifying drugs. Unlike traditional medications that primarily aim to slow disease progression, aerobic exercise may improve physical fitness, reduce fatigue, and enhance quality of life. The specific intervention, MS: Cycle, involves structured, supervised stationary cycling sessions, which could provide a targeted way to boost cardiovascular health and muscle strength. This exercise-based approach is particularly promising as it empowers patients to actively participate in their own health management, possibly leading to benefits beyond what current drugs can achieve alone.

What evidence suggests that aerobic exercise might be an effective treatment for multiple sclerosis?

Research shows that aerobic exercise, which participants in this trial may receive, offers many benefits for people with multiple sclerosis (MS). Studies have found that it can help with balance, walking, and stamina. Participants in these studies reported feeling less tired and experiencing a better quality of life. One study discovered that just two exercise sessions per week improved mood, with the positive effects lasting for months. Overall, exercise boosts both physical and mental health for those with MS. ^{1 2 3 6 7}

Who Is on the Research Team?

Lindsey Wooliscroft, MD, MS

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-64 with a confirmed diagnosis of multiple sclerosis (MS) who have internet access and can do virtual visits. They must not be very active, pregnant, or have had recent MS treatments or relapses. Changes in their MS medication within the last 6 months or certain medications affecting tests are also disqualifiers.

Inclusion Criteria

A doctor has confirmed that you have MS using specific guidelines from 2017.

Your somatosensory evoked potential test results show certain patterns that are not within the normal range.

Have access to the internet and a device that can access virtual visits

Exclusion Criteria

I have had a multiple sclerosis flare-up in the last 3 months.

I haven't changed my MS treatment in the last 6 months.

You regularly do more than 30 minutes of aerobic exercise each week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 24-week aerobic stationary cycling intervention to explore if aerobic exercise independently promotes remyelination in people with multiple sclerosis.

24 weeks

3 sessions per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of remyelination and physical function.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic exercise
• Education Group Control

Trial Overview The study is testing if aerobic exercise like stationary cycling can help repair nerve insulation damage caused by MS. Participants will either join an education group as a control or engage in the exercise program to see if it makes a difference.

How Is the Trial Designed?

Group I: MS: Cycle Experimental Treatment 1 Intervention

Twenty-two participants in the clinical trial arm will be randomized to MS:Cycle: an aerobic exercise intervention on a stationary ergometer. Participants will exercise thrice weekly for 30 minutes with graded supervision for 24 weeks.

Group II: MS: Take Control Active Control 1 Intervention

Twenty-two participants in the clinical trial arm will be randomized to MS: Take Control (MSTC): a monthly, hour-long MS education control group led by a trained facilitator.

Aerobic exercise is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Aerobic Exercise for:

• Rehabilitation after stroke
• Improvement of physical function
• Enhancement of cognitive function
• Reduction of depression

Approved in European Union as Aerobic Exercise for:

• Cardiovascular rehabilitation
• Improvement of physical function
• Enhancement of cognitive function

Approved in Canada as Aerobic Exercise for:

• Rehabilitation after stroke
• Improvement of physical function
• Enhancement of cognitive function

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

EMD Serono

Industry Sponsor

Trials

147

Recruited

27,800+

Dr. Shepard

EMD Serono

Chief Medical Officer since 2021

MD from University of Cincinnati Medical School, Fellowships in Hematology and Oncology at University of Chicago Hospitals and Clinics

Miguel Fernández Alcalde

EMD Serono

Chief Executive Officer

Bachelor's Degree in Pharmacy from the University Complutense in Madrid, MBA from the University of Alcalá de Henares, Master's Degree in Management from IESE Business School

Medical Research Foundation, Oregon

Collaborator

Trials

14

Recruited

1,100+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Myelin Repair Foundation

Collaborator

Trials

1

Recruited

60+

Oregon Clinical and Translational Research Institute

Collaborator

Trials

17

Recruited

800+

Portland VA Medical Center

Collaborator

Trials

44

Recruited

7,800+

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3883024/

Aerobic Exercise in People with Multiple Sclerosis In this study, participation in a structured aerobic exercise program two times per week for 8 weeks improved mood, with the improvement persisting over a 3- ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04539002

Aerobic Exercise for Remyelination in Multiple Sclerosis Twenty-two participants in the clinical trial arm will be randomized to MS:Cycle: an aerobic exercise intervention on a stationary ergometer. Participants will ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S221103482300250X

Effects of aerobic, resistance, and combined exercise ... Exercise training is clinically effective for improving overall HRQOL in MS and produces greater improvements in the physical domain of HRQOL than the mental ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/13524585241301613

Exercise as a Therapeutic Intervention in Multiple Sclerosis Evidence from the past 30 years supports many beneficial outcomes of exercise training in MS. Importantly, exercise improves physiological ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1551714424002696

Implementing changing behaviour towards aerobic and ... Exercise is beneficial in managing MS symptoms, including fatigue [3,4], balance [5], cognition [6], fitness and mobility [3,[7], [8], [9], [10]], and ...

7. ijmsc.org ijmsc.org/view/physical-activity-in-multiple-sclerosis-real-world-data-from-saskatchewan-canada

Physical Activity in Multiple Sclerosis: Real-World Data ... Physical activity is safe and beneficial in MS, yet it is unclear if physical activity levels are changing in real-world settings. METHODS: The ...