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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05537298
Other study ID # 77407
Secondary ID 5K23AR079583R01A
Status Recruiting
Phase
First received
Last updated
Start date October 18, 2022
Est. completion date August 1, 2027

Study information

Verified date June 2024
Source University of Kentucky
Contact Kirby P Mayer, PhD
Phone 859-218-0596
Email kpmaye2@uky.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The overarching goal of the proposed study is to determine the trajectories of physical recovery and cellular markers involved with the underlying failure to recover muscle after critical illness, while exploring which characteristics are associated with sustained physical disability. This proposal will examine muscle pathophysiology carefully aligned with physical function outcomes in order to longitudinally assess the recovery, or failed recovery, of muscle function in participants after critical illness: 1. to examine the recovery of muscle and physical function in ICU survivors through longitudinal assessments 2. to investigate the underlying cellular markers and mechanisms of muscle recovery in ICU survivors 3. to determine which cellular markers contribute to physical disability in ICU survivors up to 1 year after hospital admission


Description:

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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama
United States University of Kentucky Lexington Kentucky
United States Oklahoma Medical Research Foundation Oklahoma City Oklahoma

Sponsors (4)

Lead Sponsor Collaborator
Kirby Mayer National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Oklahoma Medical Research Foundation, University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical function Short Physical Performance Battery the change from baseline to 12-months
Primary Mitochondrial function muscle mitochondrial respirometry the change from baseline to 12-months
Primary Muscle strength lower-extremity muscle strength the change from baseline to 12-months
Primary Muscle power lower-extremity muscle power (unilateral leg-press) the change from baseline to 12-months
Secondary Physical activity actigraphy the change from baseline to 12-months
Secondary functional mobility timed-up and go test the change from baseline to 12-months
Secondary Cardiopulmonary endurance / exercise capacity 6-minute walk test the change from baseline to 12-months
Secondary self-reported health-related quality of life EuroQol-5Domains (EQ-5D) visual analog scale is a self-report of quality of life (0-100) with higher scores indicating a better perception of quality of life the change from baseline to 12-months
Secondary Muscle morphology #1 myofiber size the change from baseline to 12-months
Secondary Muscle morphology #2 myofiber type the change from baseline to 12-months
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