Clinical trial NCT06410261: Exercise Rehabilitation Program in MS Who Use Wheelchairs as a Primary Mobility Device
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Exercise
Rehabilitation
Physical function
Cognition
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: To date, there is a dearth of clinical trials examining exercise programs targeting wheelchair users with MS, but exercise programs are ideally suited for targeting the underlying causes of wheelchair use in this population, namely reduced lower extremity strength that manifests as excessive fatigue when undertaking tasks of daily life and/or interacting with the community. We propose examining a novel and highly relevant 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.

There are no relevant preliminary data in wheelchair users with MS, but the GH method has been successfully applied in other chronic, disabling diseases such as chronic kidney disease (CKD). The data from our previous and ongoing application of GH in CKD has supported improvements in a range of outcomes from physical frailty through quality of life.

This proposed research will test the effects of a 6-month exercise rehabilitation program on physical function, self-reported health-related outcomes, and cognitive function in persons with MS who use wheelchairs as a primary mobility device in the community, but who are still ambulatory. These findings may guide researchers, clinicians, and exercise specialists in the advancement of future interventions for improving the lives of persons from this segment of the population with MS.

Eligibility 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

Primary outcomes:
measure: Physical Function
timeFrame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
measure: Walking Speed
timeFrame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
measure: Lower-Extremity Function
timeFrame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
measure: Walking Endurance
timeFrame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
Secondary outcomes:
measure: Cognitive Function
timeFrame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
measure: Cognitive Function
timeFrame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
measure: Fatigue Severity
timeFrame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
measure: Fatigue Impact
timeFrame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
measure: Depressive Symptoms
timeFrame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
measure: Anxiety
timeFrame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
measure: Health-Related Quality of Life
timeFrame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
measure: Exercise Behavior
timeFrame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
measure: Usual Pattern of Mobility in Various Life-Space Levels
timeFrame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois Chicago
name: Enrico Benedetti, MD
role: PRINCIPAL_INVESTIGATOR
References: