Recruiting

Muscle Recovery

Sponsor:

Esther Dupont-Versteegden

Code:

NCT05537298

Conditions

ICU Acquired Weakness

Post Intensive Care Unit Syndrome

Muscle Weakness

Critical Illness

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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

Conditions

ICU Acquired Weakness

Post Intensive Care Unit Syndrome

Muscle Weakness

Critical Illness

Study ID

NCT05537298

Start date

Oct 18, 2022

Status verified date

Jun, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Jul 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • adult (>18 y/o)
  • admission for sepsis or acute respiratory failure with at least 72 hour stay in ICU

Exclusion Criteria:

  • patients who were not ambulatory prior to ICU admission
  • experienced >2 ICU admissions in the past year (chronic or recurrent critical illness due to the same or different reason
  • patients not expected to survive \~6months after admission
  • acute or chronic neurologic condition
  • acute or chronic orthopedic condition preventing strength/functional testing
  • morbid obesity >50 kg/m2 due to distortion of muscle ultrasonography

Study Design

Enrollment

209 participants

Anticipated

Interventions and Outcome Measures

Arms

Survivor

Patients (n = 209) surviving critical illness will be enrolled to longitudinal, observational study examining muscle strength, power, and fatigue as well as physical function at hospital discharge and repeated at 3-, 6-, and 12-month following. A subset of individuals (n =32) will undergo muscle biopsies and blood will be collected.

Control

A group of healthy controls will be recruited to serve as comparator to measures of strength, power, physical function, and muscle tissue analyses. Controls will participate in a one-time assessment.

Primary outcome measure

  • Physical function [ Time Frame: the change from baseline to 12-months ]
  • Mitochondrial function [ Time Frame: the change from baseline to 12-months ]
  • Muscle power [ Time Frame: the change from baseline to 12-months ]

Central Contacts and Locations

Central contacts

Kirby P Mayer, PhD

859-218-0596kpmaye2@uky.edu

Doug Long, MS

859-32-5438delong2@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Kirby Mayer, DPT, PhD

8593233863kpmaye2@uky.edu

Principal Investigator:

Esther E Dupont-Versteegden, PhD

More Information

Sponsor

Esther Dupont-Versteegden

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • skeletal muscle
  • physical function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Esther Dupont-Versteegden on 2026-06-26.