Multiple SclerosisMSGHNCT06410261
Exercise Rehabilitation Program in MS Who Use Wheelchairs as a Primary Mobility Device
A study testing Exercise rehabilitation program in people with Multiple Sclerosis, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Exercise rehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
Enrico Benedetti, MD, 312-636-7778, enrico@uic.edu
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Exercise rehabilitation program
- Keywords
- Exercise, Rehabilitation, Physical function, Cognition
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise rehabilitation programBehavioural
Also called GH Method
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise rehabilitation program | Experimental | • Participants will take part in a personalized, one-hour, one-on-one muscle therapy session, two days a week, for 6 months. Receives: Behavioral: Exercise rehabilitation program |
| Control | No intervention | • Participants will complete the study measures on three separate occasions and will have the option to complete the exercise rehabilitation intervention once the study reaches completion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Function
Short Physical Performance Battery (SPPB); the performance scores range between 0 (min) and 12 (max) points, higher scores reflect better physical function
Measured: 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
Measured: 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
Measured: 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
Measured: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
Secondary outcomes (9)
Cognitive Function
Symbol Digits Modalities Test (SDMT); the total test scores range between 0 (min) and 110 (max), higher scores indicate better cognitive function
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start29 Apr 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Benedetti, University of Illinois Chicago
- Investigators
- Enrico Benedetti, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410261
- Sponsor's protocol ID
- STUDY2024-0273
- Acronym
- MSGH
- Status last verified
- Jul 2026
- First submitted
- 7 May 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06410261
- Acronym / sponsor ID
- MSGH / STUDY2024-0273
- Conditions
- Multiple Sclerosis
- Keywords
- Exercise, Rehabilitation, Physical function, Cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise rehabilitation program | Experimental | Behavioral: 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. |
| Control | No intervention | –• Participants will complete the study measures on three separate occasions and will have the option to complete the exercise rehabilitation intervention once the study reaches completion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise rehabilitation programAlso: GH Method* 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. | Behavioural | Exercise rehabilitation program |
Primary outcome
Physical Function
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
9 secondary outcomes
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
Time frame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
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
Time frame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
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
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
Time frame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
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
Time frame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Enrico Benedetti, MD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise rehabilitation program in people with Multiple Sclerosis, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enrico Benedetti, MD (312-355-1493, enrico@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Function (time frame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.