Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis

June 13, 2025 updated by: University of Kansas Medical Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66103
        • Landon Center On Aging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Waitlist
listed in arm/group description
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.
Other: Multimodal Exercise Group
Listed in arm/ group descriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2023

Primary Completion (Actual)

February 23, 2025

Study Completion (Actual)

February 23, 2025

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

September 14, 2023

First Posted (Actual)

September 18, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2025

Last Update Submitted That Met QC Criteria

June 13, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00149742

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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