Exercise Training, Cognition, and Mobility in Older Adults With Multiple Sclerosis

Not Applicable

Active, not recruiting

• Conditions: Cognitive Impairment; Walking Impairment; Older Adults; Multiple Sclerosis
• Interventions: Behavioral: Aerobic and Resistance Exercise Program (GEMS program); Behavioral: Flexibility and Stretching Program (FLEX-MS program)

• Registration Number: NCT05930821
• Lead Sponsor: University of Illinois at Chicago

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 Timeline

• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-07-02
• Study Start: 2023-07-05
• Study First Posted: 2023-07-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2024-12-01
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic and Resistance Exercise Program (GEMS program)	Aerobic and Resistance Exercise Program (GEMS program)	This intervention condition will deliver the Guidelines for Exercise in Multiple Sclerosis (GEMS) program. Participants in this condition will receive a 16-week home-based, remotely supported aerobic and resistance exercise training intervention.
Flexibility and Stretching Program (FLEX-MS program)	Flexibility and Stretching Program (FLEX-MS program)	Participants in this condition will receive a 16-week home-based, remotely supported stretching program emphasizing flexibility and range of motion as important components of fitness based on Stretching for People with MS: An Illustrated Manual from the National MS Society.

Primary Outcome Measures

Name	Time	Method
Walking Speed	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	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	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	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	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	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 Outcome Measures

Name	Time	Method
Physical Activity Level	Changes in daily step count from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)	Daily step count will be measured by a waist-worn accelerometer (ActiGraph model GT3X+); a greater number of steps per day reflects a higher level of physical activity.
Exercise Behavior	Changes in the GLTEQ scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)	Godin Leisure-Time Exercise Questionnaire (GLTEQ); scores range between 0 (min) and 119 (max), higher scores indicate greater engagement in exercise behavior.
Vascular Function	Changes in cfPWV from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)	Carotid-to-femoral pulse wave velocity (cfPWV) is a biomarker for arterial stiffness and will be measured using the SphygmoCor XCEL System. A higher value (meters/second) indicates greater arterial stiffness.

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States