Exercise and Learning and Memory in Multiple Sclerosis

NCT03319771 | Terminated

• 1 other identifier: 300000373
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Physical Activity; Memory Impairment; Cognitive Change

Keywords

exercise; neuroimaging; walking; multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• Composite Learning and Memory Performance

  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

  Baseline to 12-week follow-up

Secondary Outcomes (1)

• Hippocampal Volume

  Baseline to 12-week follow-up

Study Arms (2)

Treadmill Walking Exercise Training

EXPERIMENTAL

12 weeks of supervised, progressive treadmill walking exercise training

Behavioral: Treadmill Walking Exercise Training

Stretching-and-toning Exercise Training

ACTIVE COMPARATOR

12 weeks of supervised, stretching-and-toning exercise training

Behavioral: Stretching-and-toning Exercise Training

Interventions

Treadmill Walking Exercise Training BEHAVIORAL

12-weeks of supervised, progressive treadmill walking exercise training

Treadmill Walking Exercise Training

Stretching-and-toning Exercise Training BEHAVIORAL

12-weeks of supervised, stretching-and-toning exercise training

Stretching-and-toning Exercise Training

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• EMD Serono: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0104, United States

Location

Related Publications (2)

• Sandroff BM, Wylie GR, Baird JF, Jones CD, Diggs MD, Genova H, Bamman MM, Cutter GR, DeLuca J, Motl RW. 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 Nov;110:106563. doi: 10.1016/j.cct.2021.106563. Epub 2021 Sep 5.

  PMID: 34496278 DERIVED

• Sandroff BM, Motl RW, Bamman M, Cutter GR, Bolding M, Rinker JR, Wylie GR, Genova H, DeLuca J. 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 Dec 14;8(12):e023231. doi: 10.1136/bmjopen-2018-023231.

  PMID: 30552263 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity; Memory Disorders

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brian M Sandroff, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 24, 2017
• Study Start: December 1, 2018
• Primary Completion: March 16, 2020
• Study Completion: January 3, 2021
• Last Updated: October 11, 2021

Record last verified: 2021-10

Locations

US (1)