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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a clinical trial to determine the feasibility of a stationary aerobic cycling intervention and explore if aerobic exercise independently promotes remyelination in people with multiple sclerosis (MS).

Research Team

Lindsey Wooliscroft, MD, MS

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+