Aerobic Exercise for Remyelination in Multiple Sclerosis

NCT04539002 | Completed Phase 1

• 3 other identifiers: STUDY00021045K23HD101667UL1TR002369
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Exercise; Aerobic Exercise; Remyelination; Neural Repair; Mobility

Outcome Measures

Primary Outcomes (1)

• Somatosensory Evoked Potentials (SSEPs)

  Measure of functional myelination of the somatosensory tracts of the spinal cord

  From baseline to week 24

Secondary Outcomes (17)

• 6-Minute Timed Walk (6MTW)

  From baseline to week 24

• Timed Up and Go (TUG)

  From baseline to week 24

• Timed 25-Foot Walk (T25FW)

  From baseline to week 24

• Fall frequency

  From baseline to week 24

• 9 Hole Peg Test

  From baseline to week 24

Other Outcomes (16)

• Patient Determined Disease Steps (PDDS)

  Baseline

• Activity Readiness Questionnaire (PAR-Q)

  Baseline and 12 weeks

• 6-Minute Timed Walk (6MTW)

  From baseline to week 12

Study Arms (2)

MS: Cycle

EXPERIMENTAL

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.

Behavioral: Aerobic exercise

MS: Take Control

ACTIVE COMPARATOR

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.

Behavioral: Education Group Control

Interventions

Aerobic exercise 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: Cycle

Education Group Control BEHAVIORAL

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

MS: Take Control

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Portland VA Medical Center: collaborator
• Oregon Clinical and Translational Research Institute: collaborator
• Myelin Repair Foundation: collaborator
• EMD Serono: collaborator
• Medical Research Foundation, Oregon: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 36596632 DERIVED

MeSH Terms

Conditions

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

Interventions

Exercise

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukoencephalopathies; Brain Diseases; Central Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lindsey B Wooliscroft, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single-blind, randomized, controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The first 44 participants with spinal cord injury related to multiple sclerosis (MS) will be randomized in a 1:1 ratio to a 24-week aerobic exercise intervention on a stationary ergometer or an MS education control group.

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 4, 2020
• Study Start: April 29, 2021
• Primary Completion: March 27, 2025
• Study Completion: March 27, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)