Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis

NCT06042244 | Completed

• 1 other identifier: STUDY00149742
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Frailty

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control Group

OTHER

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

Multimodal Exercise Group

EXPERIMENTAL

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

Interventions

Multimodal Exercise Group OTHER

Listed in arm/ group descriptions

Multimodal Exercise Group

Waitlist OTHER

listed in arm/group description

Control Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

Landon Center On Aging

Kansas City, Kansas, 66103, United States

Location

Related Publications (1)

• Zanotto T, Kumar DP, Tabatabaei A, Lynch SG, He J, Herda TJ, Devos H, Thiyagarajan R, Chaves L, Seldeen K, Troen BR, Sosnoff JJ. Multimodal exercise training to reduce frailty in people with multiple sclerosis: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2024 Apr 22;10(1):65. doi: 10.1186/s40814-024-01496-2.

  PMID: 38650042 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Frailty

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: September 18, 2023
• Study Start: November 20, 2023
• Primary Completion: February 23, 2025
• Study Completion: February 23, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

US (1)