Aerobic Exercise for Remyelination in Multiple Sclerosis

NCT ID: NCT04539002

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-29
• Study Completion Date: 2025-03-27

Brief Summary

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).

Detailed Description

Multiple sclerosis (MS) is the most common non-traumatic disabling neurologic condition of young adulthood, affecting more than 2.5 million people worldwide. Permanent disability in MS is caused by recurrent demyelination due to episodic inflammation, followed by neuronal damage, axonal degeneration, and progressive failure of remyelination. There is an urgent need to restore activity and participation in people with MS (pwMS), and remyelination is the most promising therapeutic strategy to accomplish this goal.

Remyelination in pwMS will likely require integration of pharmacologic and rehabilitative approaches to ensure effective remyelination of appropriate neural pathways. Aerobic exercise is an ideal complement to remyelinating medications because aerobic exercise 1) improves walking function in pwMS, and 2) promotes remyelination in animal models both independently and synergistically with medications. However, there are many unknowns that need to be addressed before aerobic exercise can be explored in multimodal clinical trials for remyelination. First, it is imperative to understand how myelination impacts disability in MS, as many other factors could contribute to reduced activity and participation. Additionally, as remyelination occurs over 12 to 24 weeks, it is imperative to establish the feasibility of similar duration of aerobic exercise interventions, and explore if exercise independently influences established remyelination outcomes before integration into multimodal strategies.

This is a randomized, single-blind, parallel clinical trial of a 24-week aerobic stationary cycling intervention to determine feasibility and explore if aerobic exercise independently promotes remyelination in pwMS.

Conditions

Multiple Sclerosis; Sclerosis; Demyelinating Diseases; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Autoimmune Diseases, CNS; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MS: Cycle

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 Type: EXPERIMENTAL

Aerobic exercise

Intervention Type: BEHAVIORAL

Aerobic exercise performed on a stationary ergometer for 30 minutes, thrice weekly, with graded supervision. Participants will participate in the intervention over 24 weeks.

MS: Take Control

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.

Group Type: ACTIVE_COMPARATOR

Education Group Control

Intervention Type: BEHAVIORAL

A monthly, hour-long, class over various MS topics and symptoms, led by a trained facilitator.

Interventions

Aerobic exercise

Aerobic exercise performed on a stationary ergometer for 30 minutes, thrice weekly, with graded supervision. Participants will participate in the intervention over 24 weeks.

Intervention Type: BEHAVIORAL

Education Group Control

A monthly, hour-long, class over various MS topics and symptoms, led by a trained facilitator.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Physician-confirmed diagnosis of MS based on the 2017 McDonald criteria
• 18-64 years old
• Have access to the internet and a device that can access virtual visits

Exclusion Criteria

• Medical or biophysical conditions that prohibit the use of a cycle ergometer or treadmill (medical readiness to be assessed by the Activity Readiness Questionnaire (PAR-Q)) or achievement of target heart rate.
• Engages in >30 minutes/week of aerobic activity regularly.
• Clinically confirmed MS relapse in the last 3 months.
• Changes in disease modifying therapy (DMT) for MS in the last 6 months.
• Pregnant women.
• Treatment with steroids for MS in the last 30 days.
• Concurrent use of 4-aminopyridine or dalfampridine (medications which can alter SSEP) and unwilling to discontinue it for 2 days prior to SSEP testing.
• Have a known history of severe spinal canal stenosis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Portland VA Medical Center

FED

Sponsor Role: collaborator

Oregon Clinical and Translational Research Institute

OTHER

Sponsor Role: collaborator

Myelin Repair Foundation

UNKNOWN

Sponsor Role: collaborator

EMD Serono

INDUSTRY

Sponsor Role: collaborator

Medical Research Foundation, Oregon

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Lindsey Wooliscroft

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lindsey B Wooliscroft, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

References

Wooliscroft L, McCoy S, Hildebrand A, Rooney W, Oken BS, Spain RI, Kuehl KS, Bourdette D, Cameron M. Protocol for an exploratory, randomised, single-blind clinical trial of aerobic exercise to promote remyelination in multiple sclerosis. BMJ Open. 2023 Jan 3;13(1):e061539. doi: 10.1136/bmjopen-2022-061539.

Reference Type: DERIVED

PMID: 36596632 (View on PubMed)

Other Identifiers

K23HD101667

Identifier Type: NIH

Identifier Source: secondary_id

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UL1TR002369

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00021045

Identifier Type: -

Identifier Source: org_study_id