Exercise and Learning and Memory in Multiple Sclerosis
Effects of Exercise Training on Learning and Memory Outcomes in Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
Reason given: Termination of study funding due to COVID-19
What was tested
Treatment tested
- Treadmill Walking Exercise Training
Compared with
- Stretching-and-toning Exercise Training
What it measured
Main measures
Composite Learning and Memory Performance
Baseline to 12-week follow-up
Thinking and memory
Other measures (1)
Hippocampal Volume
Baseline to 12-week follow-up
MRI lesions
Who could take part
MS (type not specified) · 18 to 54 · EDSS 0 to 4.0
Show the full criteria
Inclusion criteria
Inclusion/Exclusion Criteria: - All participants will: * Be between the ages of 18-54 (Males 18-44; Females 18-54) * Have a clinically definite MS diagnosis based on established criteria * Be fully-ambulatory based on Expanded Disability Status Scale (EDSS) scores between 0-4.0 * Demonstrate impairment in learning new information based on open-trial Selective Reminding Task scores at least 1.5 SD's below the normative score for healthy controls (i.e., 5th percentile) * Be relapse-free and will not have acutely taken corticosteroids for at least 30 days (i.e., relative neurologic stability) * Not have a history of major depressive disorder, schizophrenia, bipolar disorder I or II, or substance-abuse disorders. * Not be taking medications that can affect cognition (e.g., antipsychotics, benzodiazepines). * Be right-handed * Have corrected vision better than 20/80 * Not have known/diagnosed cardiovascular, metabolic, or renal disease. Individuals with known/diagnosed cardiovascular, metabolic, or renal disease who are asymptomatic will be included only with a physician's approval. * Demonstrate scores on the Mini-Mental State Examination (MMSE) of 21 or higher (no decisional impairment) * Be on a stable disease-modifying therapy regimen (i.e., at least 6 months prior to study enrollment). * Have a low risk for contraindications for MRI based on not having metal (e.g., non-MRI compatible aneurysm clips, metal shards in the body or eyes, or recently placed surgical hardware) or electronic devices (e.g., pacemaker, cochlear implant) within the body. * Not be pregnant * Not be engaging in ≥ 150 min of moderate-to-vigorous physical activity (i.e., not meeting public health guidelines for physical activity) per week * Not be actively engaging in cognitive rehabilitation, or participating in regular brain fitness activities * Demonstrate systolic blood pressure values of \< 200 mmHg or diastolic blood pressure values \< 110 mmHg at rest
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The two primary study objectives involve examining the effects of treadmill walking exercise training versus stretching-and-toning activities on the primary and secondary outcomes. Specific Aim 1: The first specific aim is to examine the effects of 3-months of treadmill walking exercise training compared with an active control condition on learning and memory outcomes in fully-ambulatory persons with MS who have impairment in learning new information. We hypothesize that those who undergo treadmill walking exercise training will demonstrate improvements in learning and memory relative to those who undergo stretching-and-toning activities. Specific Aim 2: The second specific aim is to examine the effects of 3-months of treadmill walking exercise training compared with an active control condition on hippocampal volume, hippocampal resting-state functional connectivity, and cardiorespiratory fitness in those persons with MS. We hypothesize that those who are randomly assigned to the treadmill walking exercise condition will demonstrate increases in hippocampal volume and resting-state functional connectivity (i.e., adaptive increases) and improved cardiorespiratory fitness relative to those in the stretching-and-toning condition.
Papers
Results
Effects of walking exercise training on learning and memory and hippocampal neuroimaging outcomes in MS: A targeted, pilot randomized controlled trial.Contemp Clin Trials · 2021
Results
Rationale and design of a single-blind, randomised controlled trial of exercise training for managing learning and memory impairment in persons with multiple sclerosis.BMJ Open · 2018
Loading reviews and guidelines…
History
Started
Dec 2018
Main results due
Mar 2020
Finished
Jan 2021