Exercise Rehabilitation Program in MS Who Use Wheelchairs as a Primary Mobility Device
- Conditions
- Multiple Sclerosis
- Interventions
- Behavioral: Exercise rehabilitation program
- Registration Number
- NCT06410261
- Lead Sponsor
- University of Illinois at Chicago
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise rehabilitation program Exercise rehabilitation program • Participants will take part in a personalized, one-hour, one-on-one muscle therapy session, two days a week, for 6 months.
- Primary Outcome Measures
Name Time Method Physical Function Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention) Short Physical Performance Battery (SPPB); the performance scores range between 0 (min) and 12 (max) points, higher scores reflect better physical function
Walking Speed Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention) 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
Lower-Extremity Function Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention) 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
Walking Endurance Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention) 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
- Secondary Outcome Measures
Name Time Method Anxiety Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention) Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms
Exercise Behavior Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention) Godin Leisure-Time Exercise Questionnaire (GLTEQ); scores range between 0 (min) and 119 (max), higher scores indicate greater engagement in exercise behavior
Cognitive Function Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention) California Verbal Learning Test - Second Edition (CVLT-II); the total test scores range between 0 (min) and 80 (max), higher scores indicate better cognitive function
Fatigue Severity Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention) Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity
Fatigue Impact Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention) Modified Fatigue Impact Scale (MFIS); scores range between 0 (min) and 84 (max), higher scores reflect a greater impact of fatigue on daily life
Depressive Symptoms Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention) Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms
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) Multiple Sclerosis Impact Scale (MSIS-29); scores range between 0 (min) and 100 (max), higher scores indicate greater impact of disease on daily function (i.e. worse outcomes)
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) The University of Alabama at Birmingham Study of Aging Life-Space Assessment (UAB-LSA); scores range between 0 (min) and 120 (max), higher scores indicate better mobility in various life-space levels
Trial Locations
- Locations (1)
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States