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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
Aerobic exercise performed on a stationary ergometer for 30 minutes, thrice weekly, with graded supervision. Participants will participate in the intervention over 24 weeks.
A monthly, hour-long, class over various MS topics and symptoms, led by a trained facilitator.
Oregon Health & Science University
Portland, Oregon, United States
Somatosensory Evoked Potentials (SSEPs)
Measure of functional myelination of the somatosensory tracts of the spinal cord
Time frame: From baseline to week 24
6-Minute Timed Walk (6MTW)
An assessment of exercise tolerance
Time frame: From baseline to week 24
Timed Up and Go (TUG)
A test of walking agility
Time frame: From baseline to week 24
Timed 25-Foot Walk (T25FW)
A test of walking speed
Time frame: From baseline to week 24
Fall frequency
A self-report of fall frequency over the last 30 days
Time frame: From baseline to week 24
9 Hole Peg Test
A test of upper extremity and arm function
Time frame: From baseline to week 24
Multiple Sclerosis Functional Composite (MSFC)
Composite measure of walking speed, upper extremity function and cognition.
Time frame: From baseline to week 24
Virtual aerobic exercise intervention adherence
Defined as participation in at least 80% of the exercise sessions in the trial
Time frame: From baseline to week 24
Virtual education control group adherence
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Defined as participation in at least 80% of the education group sessions in the trial
Time frame: From baseline to week 24
Average heart rate (HR) zone during exercise sessions
Average HR zone during exercise sessions
Time frame: From baseline to week 24
Brain Myelin Water Fraction (MWF)
MWF imaging of the corpus callosum, internal capsules and MS lesions
Time frame: From baseline to week 24
Symbol Digit Modalities Test (SDMT)
A test of cognitive function
Time frame: From baseline to week 24
VO2 max
A test of aerobic fitness
Time frame: From baseline to week 24
7-site skinfold test
A test of body composition
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: From baseline to weeks 24
International Physical Activity Questionnaire Short Form (IPAQ-SF)
A patient reported outcome of physical activity
Time frame: From baseline to week 24