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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06042244
Other study ID # STUDY00149742
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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