Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis

University of Kansas

Status: Completed

Conditions: Multiple Sclerosis; Frailty

Treatments: Other: Waitlist; Other: Multimodal Exercise Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06042244

STUDY00149742

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Control Group

Other group

Description:

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.

Treatment:

Other: Waitlist

Multimodal Exercise Group

Experimental group

Description:

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.

Treatment:

Other: Multimodal Exercise Group