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Trials / Active Not Recruiting

Active Not RecruitingNCT05930821

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
51 (actual)
Sponsor
University of Illinois at Chicago · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAerobic 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.
BEHAVIORALFlexibility 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.

Timeline

Start date
2023-07-05
Primary completion
2025-02-11
Completion
2025-03-31
First posted
2023-07-05
Last updated
2025-02-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05930821. Inclusion in this directory is not an endorsement.

Exercise Training, Cognition, and Mobility in Older Adults With Multiple Sclerosis (NCT05930821) · Clinical Trials Directory