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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
* The sessions will consist of a customized low-impact, resistance-base rehabilitation regime to increase muscle strength and functionality by focusing on isolating each targeted muscle, without increasing the participant's fatigue or pain level. * The goal of phase one will be to start muscle activation without increasing fatigue or pain. Low intensity, single set of 30-35 repetitions for each of the targeted muscles will be performed by the participants, followed by stretching; the goal of phase two will be to progressively develop muscle strength, without increasing pain or fatigue. A single set of 20-25 repetitions for each muscle will be prescribed, followed by stretching; during phase three, the emphasis will be on further development of muscle strength, function, and endurance.
University of Illinois at Chicago
Chicago, Illinois, United States
RECRUITINGPhysical Function
Short Physical Performance Battery (SPPB); the performance scores range between 0 (min) and 12 (max) points, higher scores reflect better physical function
Time frame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
Walking Speed
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
Time frame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
Lower-Extremity Function
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
Time frame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
Walking Endurance
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
Time frame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
Cognitive Function
Symbol Digits Modalities Test (SDMT); the total test scores range between 0 (min) and 110 (max), higher scores indicate better cognitive function
Time frame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
Cognitive Function
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
Time frame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
Fatigue Severity
Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity
Time frame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
Fatigue Impact
Modified Fatigue Impact Scale (MFIS); scores range between 0 (min) and 84 (max), higher scores reflect a greater impact of fatigue on daily life
Time frame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
Depressive Symptoms
Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms
Time frame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
Anxiety
Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms
Time frame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
Health-Related Quality of Life
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)
Time frame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
Exercise Behavior
Godin Leisure-Time Exercise Questionnaire (GLTEQ); scores range between 0 (min) and 119 (max), higher scores indicate greater engagement in exercise behavior
Time frame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
Usual Pattern of Mobility in Various Life-Space Levels
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
Time frame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
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