Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis

Conditions
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Frailty, Multiple Sclerosis

Intervention / Treatment
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* Other: Multimodal Exercise Group
* Other: Waitlist


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Group<br>Participants randomized to the control group will be put on a waitlist (passive control group) for 6 weeks. Upon completion of post-training assessment, participants in the control group will be able to receive the intervention, if they wish so. | Other: Waitlist<br>* listed in arm/group description<br>|
| Experimental: Multimodal Exercise Group<br>Participants will complete 15 minutes of virtual reality treadmill training (VRTT), followed by 30 minutes of progressive evidence-based resistance training (RT), followed by other 15 minutes of VRTT. | Other: Multimodal Exercise Group<br>* Listed in arm/ group descriptions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome | 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). | 6 weeks |