Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06042244
Collaborator
(none)
24
2
9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Multimodal Exercise Group
  • Other: Waitlist
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Primary Outcome [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Kansas Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT06042244
Other Study ID Numbers:
  • STUDY00149742
First Posted:
Sep 18, 2023
Last Update Posted:
Sep 18, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 18, 2023