Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06042244
• Other study ID #: STUDY00149742
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: June 2024

Study information

• Verified date: May 2024
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Frailty
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Multimodal Exercise Group
Listed in arm/ group descriptions
• Waitlist
listed in arm/group description

Locations

Country	Name	City	State
United States	Landon Center On Aging	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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