Recruiting

Exercise Rehabilitation

Sponsor:

University of Illinois at Chicago

Code:

NCT06410261

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise rehabilitation program

Study Details

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.

Conditions

Multiple Sclerosis

Study ID

NCT06410261

Start date

Apr 29, 2024

Status verified date

Jul, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: Control

• 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.

Interventions

Exercise rehabilitation program

  • 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.

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) ]
  • Walking Speed [ 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 [ Time Frame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention) ]
  • Walking Endurance [ Time Frame: Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention) ]

Central Contacts and Locations

Central contacts

Enrico Benedetti, MD

312-355-1493enrico@uic.edu

Ilaria Santi

312-285-9653isanti@uic.edu

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Enrico Benedetti, MD

312-636-7778enrico@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Exercise
  • Rehabilitation
  • Physical function
  • Cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-07-13.