Status:
TERMINATED
Exercise and Learning and Memory in Multiple Sclerosis
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
EMD Serono
Conditions:
Multiple Sclerosis
Physical Activity
Eligibility:
All Genders
18-54 years
Phase:
NA
Brief Summary
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: Th...
Detailed Description
The proposed study involves a single-blind, Phase I randomized controlled trial (RCT) on the effects of supervised treadmill walking exercise training on learning and memory, hippocampal structure/fun...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03319771
Start Date
December 1 2018
End Date
January 3 2021
Last Update
October 11 2021
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0104