NCT07225257 · University of Kentucky
Recovery of Physical Function After Critical Illness In Older Adults
(RETURN)
What this study is about
The proposed study is a forward-looking, 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.
View original scientific description
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.
Primary outcome measures
Muscle Strength measured by Chair Rise Test
Time frame: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.
Performance on 5x sit to stand test will be the primary outcome measure representing lower extremity muscle strength ; measured as time in seconds to complete 5 repetitive sit-stands.
Functional Capacity
Time frame: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.
The 6-minute walk test (6MWT), which measures the distance a participant can walk in six minutes and serves as an indicator of cardiopulmonary function, will be used as a primary outcome.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Lexington, Kentucky
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 28, 2026 · Source of record for eligibility and locations