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

NCT ID: NCT06410261

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-29
• Study Completion Date: 2027-07-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise rehabilitation program

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

GH Method

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Enrico Benedetti

Department Head

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enrico Benedetti, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois Chicago

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Enrico Benedetti, MD

Role: CONTACT

enrico@uic.edu

312-355-1493

Ilaria Santi

Role: CONTACT

isanti@uic.edu

312-285-9653

Facility Contacts

Enrico Benedetti, MD

Role: primary

enrico@uic.edu

312-636-7778

Other Identifiers

STUDY2024-0273

Identifier Type: -

Identifier Source: org_study_id