Aerobic Exercise for Remyelination in Multiple Sclerosis
- Conditions
- Multiple SclerosisAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating Autoimmune Diseases, CNSSclerosisDemyelinating DiseasesExercise
- Interventions
- Behavioral: Education Group ControlBehavioral: Aerobic exercise
- Registration Number
- NCT04539002
- Lead Sponsor
- Oregon Health and Science University
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MS: Take Control Education Group 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. MS: Cycle Aerobic exercise 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.
- Primary Outcome Measures
Name Time Method Somatosensory Evoked Potentials (SSEPs) From baseline to week 24 Measure of functional myelination of the somatosensory tracts of the spinal cord
- Secondary Outcome Measures
Name Time Method 9 Hole Peg Test From baseline to week 24 A test of upper extremity and arm function
Timed 25-Foot Walk (T25FW) From baseline to week 24 A test of walking speed
Virtual aerobic exercise intervention adherence From baseline to week 24 Defined as participation in at least 80% of the exercise sessions in the trial
VO2 max From baseline to week 24 A test of aerobic fitness
7-site skinfold test From baseline to week 24 A test of body composition
Fall frequency From baseline to week 24 A self-report of fall frequency over the last 30 days
Multiple Sclerosis Functional Composite (MSFC) From baseline to week 24 Composite measure of walking speed, upper extremity function and cognition.
Average heart rate (HR) zone during exercise sessions From baseline to week 24 Average HR zone during exercise sessions
Brain Myelin Water Fraction (MWF) From baseline to week 24 MWF imaging of the corpus callosum, internal capsules and MS lesions
6-Minute Timed Walk (6MTW) From baseline to week 24 An assessment of exercise tolerance
Timed Up and Go (TUG) From baseline to week 24 A test of walking agility
Virtual education control group adherence From baseline to week 24 Defined as participation in at least 80% of the education group sessions in the trial
Symbol Digit Modalities Test (SDMT) From baseline to week 24 A test of cognitive function
Health-related quality of life (QoL) From baseline to weeks 24 Neuro-QoL questionnaires of upper and lower extremity function, depression, sleep, and self efficacy
Modified Fatigue Impact Scale (MFIS) From baseline to week 24 A patient reported outcome of fatigue severity with a range of 0-84 (higher scores indicate more fatigue).
Pain Effects Scale (PES) From baseline to week 24 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).
International Physical Activity Questionnaire Short Form (IPAQ-SF) From baseline to week 24 A patient reported outcome of physical activity
Trial Locations
- Locations (1)
Oregon Health & Science University
🇺🇸Portland, Oregon, United States