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Clinical Trials/NCT06042244
NCT06042244
Completed
N/A

Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis

University of Kansas Medical Center1 site in 1 country16 target enrollmentNovember 20, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
University of Kansas Medical Center
Enrollment
16
Locations
1
Primary Endpoint
Primary Outcome
Status
Completed
Last Updated
10 months ago

Overview

Brief Summary

Study Significance: This proposed investigation is designed to examine the feasibility of an exercise-based intervention to reduce frailty in people living with MS. The proposed research will be the first to establish the feasibility of targeting frailty in pwMS and will begin to examine the dynamic nature of frailty in MS. These advances will pave the way for planned prospective studies toward effective targets for diagnostics, and rehabilitation of frailty in MS.

Registry
clinicaltrials.gov
Start Date
November 20, 2023
End Date
February 23, 2025
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Subjects must be aged 40-65 years old to be enrolled in this study.
  • Subjects must meet 3 of 5 frailty criteria (weight loss; exhaustion; weakness; slowness; inactivity) to be considered.
  • Subjects must have a confirmed diagnosis of MS by the treating neurologist
  • be free from MS relapses in the last 30 days
  • have an Expanded Disability Status Scale (EDSS) score ≤ 6.0
  • be fluent in spoken and written English.

Exclusion Criteria

  • unable to walk unassisted for at least ten meters
  • are diagnosed with other clinically important neurological conditions (such as Parkinson's Disease, epilepsy, etc.)
  • exhibit severe cognitive impairment (as determined by a Mini-Cog score \<3)
  • are diagnosed with active psychiatric problems.
  • unstable cardiovascular conditions (e.g., malignant arrhythmias, critical mitral stenosis, clinically severe left ventricular outflow obstruction, critical proximal coronary artery stenosis)
  • arthritis of the lower limbs
  • acute lower back or lower limbs pain
  • rheumatic and/or severe orthopedic problems that may interfere with resistance training.

Outcomes

Primary Outcomes

Primary Outcome

Time Frame: 6 weeks

Preliminary efficacy of multimodal exercise in improving frailty \[Time frame: The EFIP outcome will be assessed at baseline and at 6-weeks post-intervention\] Frailty will be evaluated through the Evaluative Frailty Index for Physical Activity (EFIP).

Study Sites (1)

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