Running, not recruitingNot a drug-phase studyMS (type not specified)NCT05930821

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Aerobic and Resistance Exercise Program (GEMS program)

Compared with

  • Flexibility and Stretching Program (FLEX-MS program)

What it measured

Main measures

  • Cognitive Function

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

    Thinking and memory
  • Cognitive Function

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

    Thinking and memory
  • 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

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

  • Functional Mobility

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

    Walking and mobility
  • Walking Endurance

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

    Walking and mobility
  • Walking Speed

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

    Disability progressionWalking and mobility

Other measures (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 function
  • Physical Activity Level

    Changes in daily step count from Baseline (pre-intervention), after 16 weeks (post-intervention), and after 32 weeks (follow-up)

    Physical function
  • Exercise Behavior

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

    Physical function
  • 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)

    Blood or spinal fluid markers
  • Vascular Function

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

    Blood or spinal fluid markers

Who could take part

MS (type not specified) · 50 and over

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Jul 2023

    2. Main results due

      Feb 2025

    3. Finished

      Mar 2025

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