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

NCT06410261 | Recruiting

• 1 other identifier: STUDY2024-0273
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Exercise; Rehabilitation; Physical function; Cognition

Outcome Measures

Primary Outcomes (4)

• Physical Function

  Short Physical Performance Battery (SPPB); the performance scores range between 0 (min) and 12 (max) points, higher scores reflect better physical function

  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

  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

  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

  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

  Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)

• Cognitive Function

  Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)

• Fatigue Severity

  Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)

• Fatigue Impact

  Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)

• Depressive Symptoms

  Changes in physical function scores from Baseline (pre-intervention), after 3 months (mid-intervention), and after 6 months (post-intervention)

Study Arms (2)

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.

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.

Interventions

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.

Also known as: GH Method

Exercise rehabilitation program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Enrico Benedetti, MD

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrico Benedetti, MD

CONTACT

312-355-1493; enrico@uic.edu

Ilaria Santi

CONTACT

312-285-9653; isanti@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Head

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 13, 2024
• Study Start: April 29, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)