Clinical trial NCT05930821: Exercise Training, Cognition, and Mobility in Older Adults With Multiple Sclerosis
Official title: Exercise Training, Cognition, and Mobility in Older Adults With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Older Adults
Multiple Sclerosis
Cognitive Impairment
Walking Impairment
Keywords: Cognition
Walking
Exercise
Physical Activity
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 51
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive Function
timeFrame: Changes in BICAMS test scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
measure: Cognitive Function
timeFrame: Changes in NIH toolbox cognitive test scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
measure: Physical Function
timeFrame: Changes in physical function scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
measure: Lower-extremity Function
timeFrame: Changes in lower-extremity function scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
measure: Functional Mobility
timeFrame: Changes in functional mobility scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
measure: Walking Endurance
timeFrame: Changes in walking endurance scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
measure: Walking Speed
timeFrame: Changes in walking speed scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
Secondary outcomes:
measure: Physical Activity Level
timeFrame: Changes in time spent in MVPA from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
measure: Physical Activity Level
timeFrame: Changes in daily step count from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
measure: Exercise Behavior
timeFrame: Changes in the GLTEQ scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
measure: Vascular Function
timeFrame: Changes in central blood pressure from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
measure: Vascular Function
timeFrame: Changes in augmentation index from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
measure: Vascular Function
timeFrame: Changes in cfPWV from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
Other outcomes:
measure: Fatigue Severity
timeFrame: Changes in fatigue severity scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
measure: Fatigue Impact
timeFrame: Changes in fatigue impact scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
measure: Depressive Symptoms
timeFrame: Changes in depressive symptoms scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
measure: Anxiety
timeFrame: Changes in anxiety scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
measure: Level of Pain
timeFrame: Changes in pain level from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
measure: Sleep Quality
timeFrame: Changes in sleep quality scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
measure: Health-related Quality of Life
timeFrame: Changes in SF-36 scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
measure: Health-related Quality of Life
timeFrame: Changes in MSIS-29 scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Peixuan Zheng, PhD
role: PRINCIPAL_INVESTIGATOR
References: