Exercise Training, Cognition, and Mobility in Older Adults With Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Walking Speed
Study Overview
Brief Summary
The overall objective of the proposed randomized controlled (RCT) is to determine the feasibility and efficacy of a 16-week theory-based, remotely-delivered, combined exercise (aerobic and resistance) training intervention for improving cognitive and physical function in older adults (50+ years) with multiple sclerosis (MS) who have mild-to-moderate cognitive and walking impairment. Participants (N=50) will be randomly assigned into exercise training (combined aerobic and resistance exercise) condition or active control (flexibility and stretching) condition. The 16-week intervention will be delivered and monitored remotely within a participant's home/community and supported by Zoom-based chats guided by social cognitive theory (SCT) via a behavioral coach. Participants will receive training materials (e.g., prescriptive manual and exercise equipment), one-on-one coaching, action-planning via calendars, self-monitoring via logs, and SCT-based newsletters. It is hypothesized that the home-based exercise intervention will yield beneficial effects on cognition, mobility, physical activity, and vascular function compared with an active control condition (flexibility and stretching intervention), and these improvements will be sustained during a 16-week follow-up period.
Detailed Description
Multiple sclerosis (MS) is an immune-mediated and neurodegenerative disease of the central nervous system that is markedly increasing in prevalence amongst older adults. Older adults with MS present with poor health status and functioning, cognitive and ambulatory difficulty, dependence for activities of daily living, and reduced physical activity participation. The common approach for managing MS involves disease-modifying drugs, yet this first-line approach for medical management has little efficacy in older MS age groups (i.e., those 50+ years of age). Exercise training has been recognized as a promising approach for maintaining and/or restoring physical and cognitive health in older adults from the general population and younger adults with MS. To date, there is a dearth of research examining the benefits of exercise training among older adults with MS. The current study proposes a remotely-delivered exercise training program for improving cognition and mobility among older adults with MS. The proposed research adopts an innovative intervention approach (via telerehabilitation) with rigorous design for evaluating the feasibility and efficacy of a home-based exercise intervention program in older adults with MS who have cognitive and walking impairment. This exercise training program adopts an innovative intervention approach via telerehabilitation and is convenient and accessible for older adults with MS. This research may have practical relevance for improving physical activity among older adults with MS through alleviating travel concerns and reducing environmental/social barriers. If successful, the proposed project will provide foundations for implementing larger, high-quality RCTs using remotely-delivered exercise intervention for managing the consequences of aging and MS and ultimately contributing to successful aging with MS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 50 years or older
- •Diagnosis of MS
- •Relapse-free for the past 30 days
- •Internet and e-mail access
- •Ability to travel to the laboratory (for testing only)
- •Willingness to complete the assessments and be randomized
- •Ambulatory with or without a single-point assistive device
- •Mild-to-moderate cognitive impairment (TICS-M; MSNQ)
- •Walking impairment (MSWS-12)
Exclusion Criteria
- •Individuals not meeting above inclusion criteria
- •Individuals with moderate to high risk for contraindications of possible injury or death when undertaking strenuous or maximal exercise (PARQ)
- •Individuals diagnosed with other neurological conditions or cardiovascular diseases
Outcomes
Primary Outcomes
Walking Speed
Time Frame: Changes in walking speed scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
Timed 25-foot Walking Test (T25FW); the score is the average speed (25 feet divided by time, ft/s) for completing two trials. The minimum and maximum scores (time) depend on individuals' performance. A faster speed represents better ambulatory performance.
Physical Function
Time Frame: Changes in physical function scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
Short Physical Performance Battery (SPPB); the performance scores range between 0 (min) and 12 (max) points, higher scores reflect better physical function.
Functional Mobility
Time Frame: Changes in functional mobility scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
Timed Up and Go Test (TUG); the score is the average time (in seconds) for completing two trials. The minimum and maximum scores depend on individuals' performance; shorter time (lower scores) reflects better functional mobility.
Cognitive Function
Time Frame: Changes in NIH toolbox cognitive test scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
National Institute of Health Toolbox (NIH toolbox) with customized cognitive test battery; the scores range between 0 (min) and 186 (max), higher scores indicate better cognitive function.
Walking Endurance
Time Frame: Changes in walking endurance scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
Six-Minute Walk Test (6MW); the score is the total walking distance (in meters) during the 6 minutes. The minimum value is 0 meter, and the maximum value depends on individuals' performance. A longer distance (higher scores) indicates better walking endurance.
Lower-extremity Function
Time Frame: Changes in lower-extremity function scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
30-Second Sit to Stand Test (30STS). The score is the number of complete repetitions of sit-to-stand movements performed during 30 seconds; the minimum value is 0 repetitions, and the maximum value depends on individuals' performance. Higher scores reflect better lower extremity function.
Secondary Outcomes
- Physical Activity Level(Changes in daily step count from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up))
- Exercise Behavior(Changes in the GLTEQ scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up))
- Vascular Function(Changes in cfPWV from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up))
Investigators
Peixuan Zheng
Principal Investigator
University of Illinois at Chicago