Randomized Pilot Study Evaluating the Effect of a 6-Month Exercise Rehabilitation Program on Physical and Cognitive Function in Persons With MS Who Use Wheelchairs as a Primary Mobility Device

RecruitingNot a drug-phase studyMS (type not specified)NCT06410261

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Exercise rehabilitation program

What it measured

Main measures

  • Physical Function

    Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)

  • Walking Speed

    Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)

    Disability progressionWalking and mobility
  • Lower-Extremity Function

    Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)

  • Walking Endurance

    Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)

    Walking and mobility

Other measures (8)

  • Cognitive Function

    Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)

    Thinking and memory
  • Fatigue Severity

    Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)

    Fatigue
  • Fatigue Impact

    Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)

    Fatigue
  • Depressive Symptoms

    Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)

    Mood and sleep
  • Anxiety

    Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)

    Mood and sleep
  • Health-Related Quality of Life

    Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)

    Quality of life (reported by participants)
  • Exercise Behavior

    Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)

    Physical function
  • Usual Pattern of Mobility in Various Life-Space Levels

    Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)

    Walking and mobility

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* diagnosis of MS * age above 18 years * no relapse within last 30 days * use of wheelchair for mobility in the community * ability to walk at least 50 feet (or 65 steps) using an assistive device * low risk for contraindications of physical activity indicated by no more than a single "yes" * response on the Physical Activity Readiness Questionnaire (PAR-Q) * willingness to complete the assessments and undergo randomization

Exclusion criteria

* no diagnosis of MS * less than 18 years of age * not relapse-free within the last 30 days * no use of wheelchair as primary mobility device * no ability to walk for at least 50 feet (or 65 steps) * high risk for contraindications based on more than a single "yes" response on the PAR-Q * not willing to complete the testing procedures and undergo randomization

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

Contact details on the registry

About this trial

In the sponsor's words

Approximately 50% of people with multiple sclerosis (MS) use a wheelchair within 30 years of the initial diagnosis. Wheelchair use in MS is often associated with fatigue as a consequence of muscle weakness. Indeed, fatigue, a prevalent consequence of MS, often becomes debilitating and exhausts energetic resources when carrying-out tasks of daily life and/or interacting with the community, as these require ambulatory mobility. This experience of excessive fatigue has its roots in muscle weakness and results in reliance on a wheelchair for mobility, and the dependency on a wheelchair may further reduce muscular strength, particularly of the lower extremities. We propose that wheelchair users with MS can increase muscular strength through a personalized exercise rehabilitation, and this in turn will improve ambulatory performance and possibly reduce fatigue. To date, no research has examined the effects of this specific exercise rehabilitation program (GH method) on physical function and other disease-related outcomes in persons with MS who use wheelchairs as a primary mobility device.

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History

    1. Started

      Apr 2024

    2. Main results due

      Jul 2026

    3. Finished

      Jul 2027

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