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Completed

NCT Number: NCT06042244

Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis

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.

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Key information

Conditions

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

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Landon Center On Aging

Kansas City, Kansas, 66103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multimodal Exercise Group

Other

Listed in arm/ group descriptions

Waitlist

Other

listed in arm/group description

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 18, 2023
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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