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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2025-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Older Adults Multiple Sclerosis Cognitive Impairment Walking Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Aerobic and Resistance Exercise Program (GEMS program)

Intervention Type BEHAVIORAL

* Remotely-coached/guided, home-based program delivered using telerehabilitation focusing on aerobic fitness and muscle strength as a mode of training.
* The exercise training prescription involves performing 3 days per week and include (a) aerobic exercise: 30+ minutes of moderate-intensity walking (≥100 steps/min) monitored by a waist-worn pedometer, and (b) resistance training: 1-2 sets, 10-15 repetitions of 5-10 exercises targeting lower and upper body, and core muscle groups using elastic bands.
* Other components of the GEMS program include appropriate exercise equipment (pedometer, resistance bands), one-on-one coaching sessions via Zoom, action-planning via calendars, logbooks for self-monitoring, and SCT-based newsletters.

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.

Group Type ACTIVE_COMPARATOR

Flexibility and Stretching Program (FLEX-MS program)

Intervention Type BEHAVIORAL

* Remotely-coached/guided, home-based program delivered using telerehabilitation focusing on stretching and range of motion as the mode of training.
* The training will involve the same frequency, duration, timeline, behavior change content, and interactions with behavioral coach as the GEMS program, and account for activity, social-contact, and attention.
* Other components of the FLEX-MS program include appropriate exercise equipment (yoga mat), one-on-one coaching sessions via Zoom, calendars, logbooks and newsletters similar to the GEMS program.

Interventions

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Aerobic and Resistance Exercise Program (GEMS program)

* Remotely-coached/guided, home-based program delivered using telerehabilitation focusing on aerobic fitness and muscle strength as a mode of training.
* The exercise training prescription involves performing 3 days per week and include (a) aerobic exercise: 30+ minutes of moderate-intensity walking (≥100 steps/min) monitored by a waist-worn pedometer, and (b) resistance training: 1-2 sets, 10-15 repetitions of 5-10 exercises targeting lower and upper body, and core muscle groups using elastic bands.
* Other components of the GEMS program include appropriate exercise equipment (pedometer, resistance bands), one-on-one coaching sessions via Zoom, action-planning via calendars, logbooks for self-monitoring, and SCT-based newsletters.

Intervention Type BEHAVIORAL

Flexibility and Stretching Program (FLEX-MS program)

* Remotely-coached/guided, home-based program delivered using telerehabilitation focusing on stretching and range of motion as the mode of training.
* The training will involve the same frequency, duration, timeline, behavior change content, and interactions with behavioral coach as the GEMS program, and account for activity, social-contact, and attention.
* Other components of the FLEX-MS program include appropriate exercise equipment (yoga mat), one-on-one coaching sessions via Zoom, calendars, logbooks and newsletters similar to the GEMS program.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

* 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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No