Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K23HD101667 | U.S. NIH Grant/Contract | View source | |
| UL1TR002369 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Portland VA Medical Center | FED |
| Oregon Clinical and Translational Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Somatosensory Evoked Potentials (SSEPs) | Measure of functional myelination of the somatosensory tracts of the spinal cord | From baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 6-Minute Timed Walk (6MTW) | An assessment of exercise tolerance | From baseline to week 24 |
| Timed Up and Go (TUG) | A test of walking agility |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Determined Disease Steps (PDDS) | A patient reported outcome of MS disability ranging from 0-8 (with higher scores indicating increased disability). | Baseline |
| Activity Readiness Questionnaire (PAR-Q) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lindsey B Wooliscroft, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36596632 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Myelin Repair Foundation | UNKNOWN |
| EMD Serono | INDUSTRY |
| Medical Research Foundation, Oregon | OTHER |
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.
Not provided
Not provided
Single-blind, randomized, controlled
| Education Group Control | Behavioral | A monthly, hour-long, class over various MS topics and symptoms, led by a trained facilitator. |
|
| From baseline to week 24 |
| Timed 25-Foot Walk (T25FW) | A test of walking speed | From baseline to week 24 |
| Fall frequency | A self-report of fall frequency over the last 30 days | From baseline to week 24 |
| 9 Hole Peg Test | A test of upper extremity and arm function | From baseline to week 24 |
| Multiple Sclerosis Functional Composite (MSFC) | Composite measure of walking speed, upper extremity function and cognition. | From baseline to week 24 |
| Virtual aerobic exercise intervention adherence | Defined as participation in at least 80% of the exercise sessions in the trial | 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 | From baseline to week 24 |
| Average heart rate (HR) zone during exercise sessions | Average HR zone during exercise sessions | From baseline to week 24 |
| Brain Myelin Water Fraction (MWF) | MWF imaging of the corpus callosum, internal capsules and MS lesions | From baseline to week 24 |
| Symbol Digit Modalities Test (SDMT) | A test of cognitive function | From baseline to week 24 |
| VO2 max | A test of aerobic fitness | From baseline to week 24 |
| 7-site skinfold test | A test of body composition | 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). | From baseline to week 24 |
| Pain Effects Scale (PES) | A patient reported outcome of pain with a range of 6-30 (higher scores indicate a greater impact of pain on a person's mood or behavior). | From baseline to week 24 |
| Health-related quality of life (QoL) | Neuro-QoL questionnaires of upper and lower extremity function, depression, sleep, and self efficacy | From baseline to weeks 24 |
| International Physical Activity Questionnaire Short Form (IPAQ-SF) | A patient reported outcome of physical activity | From baseline to week 24 |
An assessment of safety to participate in exercise
| Baseline and 12 weeks |
| 6-Minute Timed Walk (6MTW) | An assessment of exercise tolerance | From baseline to week 12 |
| Timed Up and Go (TUG) | A test of walking agility | From baseline to week 12 |
| Timed 25-Foot Walk (T25FW) | A test of walking speed | From baseline to week 12 |
| Fall frequency | A self-report of fall frequency over the last 30 days | From baseline to week 12 |
| 9 Hole Peg Test | A test of upper extremity and arm function | From baseline to week 12 |
| Multiple Sclerosis Functional Composite (MSFC) | Composite measure of walking speed, upper extremity function and cognition. | From baseline to week 12 |
| Symbol Digit Modalities Test (SDMT) | A test of cognitive function | From baseline to week 12 |
| Modified Fatigue Impact Scale (MFIS) | A patient reported outcome of fatigue severity with a range of 0-84 (higher scores indicate more fatigue). | From baseline to week 12 |
| Pain Effects Scale (PES) | A patient reported outcome of pain with a range of 6-30 (higher scores indicate a greater impact of pain on a person's mood or behavior). | From baseline to week 12 |
| Somatosensory Evoked Potentials (SSEPs) | Measure of functional myelination of the somatosensory tracts of the spinal cord | From baseline to week 12 |
| Strength testing | Strength of the quadriceps, hamstrings, and hand grip is measured with dynamometers | From baseline to week 24 |
| Strength testing | Strength of the quadriceps, hamstrings, and hand grip is measured with dynamometers | From baseline to week 12 |
| Health-related quality of life (QoL) | Neuro-QoL questionnaires of upper and lower extremity function, depression, sleep, and self efficacy | From baseline to weeks 12 |
| International Physical Activity Questionnaire Short Form (IPAQ-SF) | A patient reported outcome of physical activity | From baseline to week 12 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 16, 2026 |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D012598 | Sclerosis |
| D003711 | Demyelinating Diseases |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D056784 | Leukoencephalopathies |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided