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

NCT05930821 | Active Not Recruiting DMC

• 1 other identifier: 2022-1282
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Older Adults; Multiple Sclerosis; Cognitive Impairment; Walking Impairment

Keywords

Cognition; Walking; Exercise; Physical Activity

Outcome Measures

Primary Outcomes (7)

• Cognitive Function

  Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS); the total test scores range between 0 (min) and 236 (max), higher scores indicate better cognitive function.

  Changes in BICAMS test scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)

• Cognitive Function

  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.

  Changes in NIH toolbox cognitive test scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)

• Physical Function

  Short Physical Performance Battery (SPPB); the performance scores range between 0 (min) and 12 (max) points, higher scores reflect better physical function.

  Changes in physical function scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)

• Lower-extremity Function

  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.

  Changes in lower-extremity function scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)

• Functional Mobility

  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.

  Changes in functional mobility scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)

• Walking Endurance

  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.

  Changes in walking endurance scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)

• Walking Speed

  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.

  Changes in walking speed scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)

Secondary Outcomes (6)

• Physical Activity Level

  Changes in time spent in MVPA from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)

• 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 central blood pressure from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)

• Vascular Function

  Changes in augmentation index from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)

Other Outcomes (8)

• Fatigue Severity

  Changes in fatigue severity scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)

• Fatigue Impact

  Changes in fatigue impact scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)

• Depressive Symptoms

  Changes in depressive symptoms scores from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)

Study Arms (2)

Aerobic and Resistance Exercise Program (GEMS program)

EXPERIMENTAL

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.

Behavioral: Aerobic and Resistance Exercise Program (GEMS program)

Flexibility and Stretching Program (FLEX-MS program)

ACTIVE COMPARATOR

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.

Behavioral: Flexibility and Stretching Program (FLEX-MS program)

Interventions

Aerobic and Resistance Exercise Program (GEMS program) 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.

Aerobic and Resistance Exercise Program (GEMS program)

Flexibility and Stretching Program (FLEX-MS program) 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.

Flexibility and Stretching Program (FLEX-MS program)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Zheng P, Phillips SA, Duffecy J, DeJonge SR, DuBose NG, Motl RW. Remotely-delivered exercise training program for improving physical and cognitive functions among older adults with multiple sclerosis: Protocol for an NIH stage-I randomized controlled trial. Contemp Clin Trials. 2024 Sep;144:107636. doi: 10.1016/j.cct.2024.107636. Epub 2024 Jul 20.

  PMID: 39038700 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Cognitive Dysfunction; Motor Activity

Interventions

Pliability

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Peixuan Zheng, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: July 5, 2023
• Study Start: July 5, 2023
• Primary Completion: February 11, 2025
• Study Completion: March 31, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)