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.
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: June 2024
- Other: Multimodal Exercise Group
- Listed in arm/ group descriptions
- Other: Waitlist
- listed in arm/group description
Arms, Groups and Cohorts
- Other: Control Group
- 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.
- Experimental: Multimodal Exercise Group
- 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.
Clinical Trial Outcome Measures
- 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).
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: 40 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Kansas Medical Center
- Provider of Information About this Clinical Study
- Overall Contact(s)
- Tobia Zanotto, PhD, 217-721-4852, firstname.lastname@example.org
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