Multiple SclerosisNCT04539002
Aerobic Exercise for Remyelination in Multiple Sclerosis
A study testing Aerobic exercise in people with Multiple Sclerosis and Sclerosis, run by Oregon Health and Science University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Multiple Sclerosis, Sclerosis, Demyelinating Diseases
- What is being tested?
- Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2021to 27 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
- (Inclusion criteria to advance to clinical trial) Somatosensory evoked potential (SSEP) latency z-score ≥2 for P40 or inter-side difference in z-score ≥2 for P40
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Aerobic Exercise to Improve Mobility in Multiple Sclerosis: Optimizing Design and Execution for a Full-scale Multimodal Remyelination Clinical 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).
Read the 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
- Being tested
- Aerobic exercise, Education Group Control
- Keywords
- Exercise, Aerobic Exercise, Remyelination, Neural Repair, Mobility
- Medical subject headings
- Multiple Sclerosis, Sclerosis, Demyelinating Diseases, Autoimmune Diseases of the Nervous System, Nervous System Diseases, Demyelinating Autoimmune Diseases, CNS, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
Aerobic exercise performed on a stationary ergometer for 30 minutes, thrice weekly, with graded supervision. Participants will participate in the intervention over 24 weeks.
Education Group ControlBehavioural
A monthly, hour-long, class over various MS topics and symptoms, led by a trained facilitator.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Education Group Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Somatosensory Evoked Potentials
Somatosensory evoked potentials (SSEPs) are a measure of functional myelination of the somatosensory tracts (i.e., the time it takes for a sensory signal to travel from the limb to the cortex of the brain). Z-scores were calculated for each leg, adjusting for participant height. A Z-score measures how many standard deviations a specific data point is from the average (mean) of a dataset (where a Z-score of 0 represents the population mean). Averaged Z-scores of the cortical latencies of both legs (i.e., P40) were compared between baseline and week 24 (post-intervention). Z-scores increase with myelin damage in multiple sclerosis (MS). Those with an average Z-score of ≥2 were considered abnormal.
Measured: From baseline to week 24
Secondary outcomes (14)
6-Minute Timed Walk (6MTW)
An assessment of exercise tolerance
Measured: From baseline to week 24
Timed Up and Go (TUG)
A test of walking agility
Measured: From baseline to week 24
Timed 25-Foot Walk (T25FW)
A test of walking speed
Measured: From baseline to week 24
9 Hole Peg Test
A test of upper extremity and arm function. Average of both upper extremity times in seconds.
Measured: From baseline to week 24
Multiple Sclerosis Functional Composite (MSFC)
The Multiple Sclerosis Functional Composite (MSFC) is an average of the Z-scores for three individual tests measuring walking speed, upper extremity function and cognition. A Z-score measures how many standard deviations a specific data point is from the average (mean) of a dataset (where a Z-score of 0 represents the population mean). Higher MSFC scores reflect increased multiple sclerosis disability.
Measured: From baseline to week 24
Virtual Aerobic Exercise Intervention Adherence
Defined as participation in at least 80% of the exercise sessions in the trial
Measured: From baseline to week 24
Virtual Education Control Group Adherence
Defined as participation in at least 80% of the education group sessions in the trial
Measured: From baseline to week 24
Average Minutes Spent at Goal Heart Rate (HR) During Exercise
Average number of minutes per session that MS: Cycle participants spent in their goal HR zone (>=70% HR max) during exercise sessions.
Measured: From baseline to week 24
Brain Myelin Water Fraction (MWF)
MWF imaging of the corpus callosum, internal capsule, thalamus, and frontal white matter.
Measured: From baseline to week 24
Symbol Digit Modalities Test (SDMT)
The Symbol Digit Modalities Test (SDMT) is a test of cognitive function. The score reflects how many correct number-symbol pairings an individual can complete in 90 seconds. Higher scores represent better cognitive processing speed and executive function. Scores can range to 0 (i.e., no correct number-symbol pairings) to a theoretically infinite score.
Measured: From baseline to week 24
VO2 Max
A test of aerobic fitness
Measured: From baseline to week 24
Modified Fatigue Impact Scale (MFIS)
A patient reported outcome of fatigue severity with a range of 0-84 (higher scores indicate more fatigue).
Measured: From baseline to week 24
Quality of Life in Neurological Disorders (Neuro-QoL)
Quality of Life in Neurological Disorders (Neuro-QoL) questionnaires are patient-reported outcomes of upper and lower extremity function, depression, sleep, and self efficacy. The scores are based on T-scores which is a standardized score with a set mean of 50 and a standard deviation of 10. This scale is used to convert raw data into positive, comparable scores (e.g., T = z × 10 + 50). Increased symptom severity is reflected by lower Neuro-QoL Upper Extremity Function scores, lower Neuro-QoL Lower Extremity Function scores, higher Neuro-QoL Depression scores, higher Neuro-QoL Sleep scores, and lower Self Efficacy scores.
Measured: From baseline to weeks 24
International Physical Activity Questionnaire Short Form (IPAQ-SF)
A patient reported outcome of physical activity reported as the calculated average Metabolic Equivalent of Task (MET) units per week.
Measured: From baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start29 Apr 2021
- Primary completion27 Mar 2025
- Study completion27 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Portland VA Medical Center, Oregon Clinical and Translational Research Institute, Myelin Repair Foundation, EMD Serono, Medical Research Foundation, Oregon, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Lindsey Wooliscroft, Oregon Health and Science University
- Investigators
- Lindsey B Wooliscroft, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539002
- Sponsor's protocol ID
- STUDY00021045
- Other IDs
- K23HD101667, UL1TR002369
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2020
- Last updated
- 23 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36596632
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Exercise to Improve Mobility in Multiple Sclerosis: Optimizing Design and Execution for a Full-scale Multimodal Remyelination Clinical Trial
- ClinicalTrials.gov ID
- NCT04539002
- Acronym / sponsor ID
- STUDY00021045
- Conditions
- Multiple Sclerosis, Sclerosis, Demyelinating Diseases, Autoimmune Diseases of the Nervous System, Nervous System Diseases, Demyelinating Autoimmune Diseases, CNS
- Keywords
- Exercise, Aerobic Exercise, Remyelination, Neural Repair, Mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Portland VA Medical Center, Oregon Clinical and Translational Research Institute, Myelin Repair Foundation, EMD Serono, Medical Research Foundation, Oregon, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 27 Mar 2025 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 4 Sep 2020 (actual)
- Results
- Posted 23 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| MS: Cycle | Experimental | Behavioral: Aerobic exerciseTwenty-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. |
| MS: Take Control | Active comparator | Behavioral: Education Group ControlTwenty-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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
- (Inclusion criteria to advance to clinical trial) Somatosensory evoked potential (SSEP) latency z-score ≥2 for P40 or inter-side difference in z-score ≥2 for P40
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseAerobic exercise performed on a stationary ergometer for 30 minutes, thrice weekly, with graded supervision. Participants will participate in the intervention over 24 weeks. | Behavioural | MS: Cycle |
| Education Group ControlA monthly, hour-long, class over various MS topics and symptoms, led by a trained facilitator. | Behavioural | MS: Take Control |
Primary outcome
Somatosensory Evoked Potentials
Time frame: From baseline to week 24
Somatosensory evoked potentials (SSEPs) are a measure of functional myelination of the somatosensory tracts (i.e., the time it takes for a sensory signal to travel from the limb to the cortex of the brain). Z-scores were calculated for each leg, adjusting for participant height. A Z-score measures how many standard deviations a specific data point is from the average (mean) of a dataset (where a Z-score of 0 represents the population mean). Averaged Z-scores of the cortical latencies of both legs (i.e., P40) were compared between baseline and week 24 (post-intervention). Z-scores increase with myelin damage in multiple sclerosis (MS). Those with an average Z-score of ≥2 were considered abnormal.
14 secondary outcomes
6-Minute Timed Walk (6MTW)
Time frame: From baseline to week 24
Timed Up and Go (TUG)
Time frame: From baseline to week 24
Timed 25-Foot Walk (T25FW)
Time frame: From baseline to week 24
9 Hole Peg Test
Time frame: From baseline to week 24
Multiple Sclerosis Functional Composite (MSFC)
Time frame: From baseline to week 24
Virtual Aerobic Exercise Intervention Adherence
Time frame: From baseline to week 24
Virtual Education Control Group Adherence
Time frame: From baseline to week 24
Average Minutes Spent at Goal Heart Rate (HR) During Exercise
Time frame: From baseline to week 24
Brain Myelin Water Fraction (MWF)
Time frame: From baseline to week 24
Symbol Digit Modalities Test (SDMT)
Time frame: From baseline to week 24
VO2 Max
Time frame: From baseline to week 24
Modified Fatigue Impact Scale (MFIS)
Time frame: From baseline to week 24
Quality of Life in Neurological Disorders (Neuro-QoL)
Time frame: From baseline to weeks 24
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time frame: From baseline to week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36596632Wooliscroft 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsey B Wooliscroft, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Multiple Sclerosis and Sclerosis, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Somatosensory Evoked Potentials (time frame: From baseline to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04539002, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.