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Exercise Rehabilitation Program in MS Who Use Wheelchairs as a Primary Mobility Device
NCT06410261 · University of Illinois at Chicago
In plain English
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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
About this study
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
Study design
Enrollment target: 24 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2024-04-29
Estimated completion: 2027-07-31
Last updated: 2024-09-20
Interventions
Behavioral: Exercise rehabilitation program
Primary outcomes
- • 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))
- • Lower-Extremity Function (Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention))
Sponsor
University of Illinois at Chicago · other
Contacts & investigators
ContactEnrico Benedetti, MD · contact · enrico@uic.edu · 312-355-1493
ContactIlaria Santi · contact · isanti@uic.edu · 312-285-9653
InvestigatorEnrico Benedetti, MD · principal_investigator, University of Illinois Chicago
All locations (1)
University of Illinois at ChicagoRecruiting
Chicago, Illinois, United States