Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis

Not Applicable

• Conditions: Multiple Sclerosis; Frailty

• Registration Number: NCT06042244
• Lead Sponsor: University of Kansas Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-21
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-18
• Study Start: 2023-11-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary Outcome	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).