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Exercise and Learning and Memory in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03319771
Recruitment Status : Not yet recruiting
First Posted : October 24, 2017
Last Update Posted : October 24, 2018
Sponsor:
Collaborator:
EMD Serono
Information provided by (Responsible Party):
Brian Sandroff, University of Alabama at Birmingham

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: 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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Physical Activity Memory Impairment Cognitive Change Behavioral: Treadmill Walking Exercise Training Behavioral: Stretching-and-toning Exercise Training Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Exercise Training on Learning and Memory Outcomes in Multiple Sclerosis
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treadmill Walking Exercise Training
12 weeks of supervised, progressive treadmill walking exercise training
Behavioral: Treadmill Walking Exercise Training
12-weeks of supervised, progressive treadmill walking exercise training

Active Comparator: Stretching-and-toning Exercise Training
12 weeks of supervised, stretching-and-toning exercise training
Behavioral: Stretching-and-toning Exercise Training
12-weeks of supervised, stretching-and-toning exercise training




Primary Outcome Measures :
  1. Composite Learning and Memory Performance [ Time Frame: Baseline to 12-week follow-up ]
    Composite z-score of performance on California Verbal Learning Test-II, Selective Reminding Task, Brief Visuospatial Memory Test-Revised, and 10/36 Spatial Recall Test


Secondary Outcome Measures :
  1. Hippocampal Volume [ Time Frame: Baseline to 12-week follow-up ]
    Volume of bilateral hippocampi measured using structural MRI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319771


Contacts
Contact: Brian M Sandroff, PhD 205-934-5972 sandroff@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35294-0104
Contact: Brian M Sandroff, PhD    205-934-5972    sandroff@uab.edu   
Principal Investigator: Brian M Sandroff, PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
EMD Serono
Investigators
Principal Investigator: Brian M Sandroff, PhD University of Alabama at Birmingham

Responsible Party: Brian Sandroff, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03319771     History of Changes
Other Study ID Numbers: 300000373
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brian Sandroff, University of Alabama at Birmingham:
exercise
neuroimaging
walking
multiple sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases