Recruiting

Observational Study

Sponsor:

University of Kentucky

Code:

NCT07225257

Conditions

Sepsis

Acute Lung Injury(ALI)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The proposed study is a prospective, observational study assessing the recovery of muscle and physical function in patients surviving critical illness (n =150) at hospital discharge (baseline) and repeated serially. Patients will be enrolled after life-saving modalities have been weaned near hospital discharge. Patients will participate in testing at baseline, 3-, 6-, 12-, and 24-months after hospital discharge. In a subset of patients (n = 18), muscle biopsies will be performed at baseline and then repeated once at either 12- or 24-months after hospital discharge.

Conditions

Sepsis

Acute Lung Injury(ALI)

Study ID

NCT07225257

Start date

Mar 11, 2026

Status verified date

May, 2026

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Jun 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • adult patients (≥40 years of age)
  • patients who have survived an ICU admission of at least 72 hours
  • diagnosis of acute lung injury or sepsis are eligible.

Exclusion Criteria:

  • individuals who were not ambulatory prior to ICU admission,
  • not expected to survive at least 6 months,
  • have a new or pre-existing brain infarct, injury, or neurological condition with deficits preventing participation in physical testing,
  • have a pre-existing geriatric syndrome that were confound recovery trajectory

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

RETURN

Survivors of critical illness

Primary outcome measure

  • Muscle Strength measured by Chair Rise Test [ Time Frame: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment. ]
  • Functional Capacity [ Time Frame: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment. ]

Central Contacts and Locations

Central contacts

Doug Long, MS

859-218-0596delong2@uky.edu

Kirby P Mayer, DPT, Ph.D.

859-218-0596kpmaye2@uky.edu

Locations

University of Kentucky, Lexington, Kentucky 40536

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Doug A Long, MS

8593231100delong2@uky.edu

Principal Investigator:

Kirby P Mayer, DPT, Ph.D.

More Information

Sponsor

University of Kentucky

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

  • sepsis
  • acute respiratory failure
  • intensive care unit
  • Acquired muscle weakness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kentucky on 2026-05-28.