Exercise Rehabilitation Program in MS Who Use Wheelchairs as a Primary Mobility Device

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

diagnosis of MS

age above 18 years

no relapse within last 30 days

use of wheelchair for mobility in the community

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise rehabilitation program

    Behavioral

    * 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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Exercise rehabilitation programExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Physical 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)
2

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)
3

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)
4

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

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