Exercise Training Effects on Cognition and Brain Function in Multiple Sclerosis: A Systematically-Developed Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Kessler Foundation
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Cognitive Processing Speed
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
Cognitive impairment is highly prevalent, poorly-managed, and disabling in persons with MS and exercise training might represent a promising approach to manage this symptom of the disease. The proposed study aims to examine the effects of 3-months of supervised, progressive (both intensity and duration) treadmill walking exercise training (designed based on pilot work and American College of Sports Medicine guidelines) compared with an active control condition (i.e., stretching-and-toning activities) on cognitive processing speed and functional MRI outcomes in 88 cognitively-impaired persons with MS. This study is critical for providing evidence supporting treadmill walking exercise training as a behavioral approach for managing slowed cognitive processing speed (i.e., the most common MS-related cognitive impairment) and improving brain health in persons with MS.
Investigators
Brian Sandroff
Principal Investigator
Kessler Foundation
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Cognitive Processing Speed
Time Frame: Baseline, Follow-up (up to 14 weeks)
Raw (Total) Score from the Symbol Digit Modalities Test (0-110; higher scores indicate faster cognitive processing speed)
Thalamocortical Resting-State Functional Connectivity Region 1
Time Frame: Follow-up at 12-weeks minus baseline
Change in functional connectivity between the thalamus and left superior medial gyrus based on fMRI. As this outcome measure reflects changes in resting-state functional connectivity, positive z-scores indicate increased connectivity and negative z-scores indicate decreased connectivity. A z-score of 0 reflects no change in resting-state functional connectivity.
Change in Thalamocortical Resting State Functional Connectivity Region 2
Time Frame: Follow-up at 12-weeks minus baseline
Resting-state functional connectivity between the thalamus and left putamen based on fMRI. As this outcome measure reflects changes in resting-state functional connectivity, positive z-scores indicate increased connectivity and negative z-scores indicate decreased connectivity. A z-score of 0 reflects no change in resting-state functional connectivity.
Secondary Outcomes
- 3-second Paced Auditory Serial Addition Test (PASAT)(Baseline, Follow-up (up to 14-weeks))
- 2-second Paced Auditory Serial Addition Test (PASAT)(Baseline, Follow-up (up to 14-weeks))
- Pattern Comparison Test(Baseline, Follow-up (up to 14-weeks))
- Community Integration Questionnaire(Baseline, Follow-up (up to 14-weeks))
- Lawton-Brody Instrumental Activities of Daily Living(Baseline, Follow-up (up to 14-weeks))
- Multiple Sclerosis Impact Scale-29 Physical Subscale(Baseline, Follow-up (up to 14-weeks))
- Timed 25-foot Walk(Baseline, Follow-up (up to 14-weeks))