Clinical trial Recruiting at 1 site Observational Ages 18 to 99

Recovery of physical function after critical illness in older adults

Official title: RETURN: Recovery of Physical Function After Critical Illness In Older Adults

Run by University of Kentucky · NCT07225257 · Data updated 2026-11-12

This study tests how well muscle strength and daily activities improve over 2 years in people aged 40 and older who survived ICU treatment for sepsis or acute lung injury.

Quick facts

Study typeObservational
Ages18 Years to 99 Years
SexAll
Enrollment150 (estimated)
SponsorUniversity of Kentucky
Academic / other
Locations1 site (Lexington, Kentucky)
StatusRecruiting
StartedMarch 11, 2026
Main results expectedJune 1, 2030
Study endsDecember 31, 2031
Registry record updatedMay 28, 2026
Trial IDNCT07225257 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults 40 years or older who survived an ICU stay of at least 72 hours for sepsis or acute lung injury and who were ambulatory before admission.

Probably not a fit

Patients who were non-ambulatory before ICU admission or who are not expected to survive at least 6 months may be less likely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, observational study following 150 ICU survivors from hospital discharge to 24 months later. Participants will undergo a battery of physical and functional tests at baseline (hospital discharge) and at 3, 6, 12, and 24 months, with a subset undergoing muscle biopsies at baseline and 12 or 24 months to explore cellular changes. The goal is to describe recovery trajectories and identify factors associated with persistent physical disability, including muscle oxidative stress and mitochondrial function. The study does not involve a treatment intervention but seeks to map long-term outcomes and underlying biology after critical illness.

Why it matters

Potential benefit: If successful, the study could clarify recovery patterns and help target interventions to those at risk for extended physical disability.

How similar studies have gone: Previous observational work has described variable long-term recovery after critical illness, with some evidence of ongoing muscle weakness.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 it's running

  • University of Kentucky, Lexington, Kentucky 40536
    Lexington, Kentucky, United States
    Recruiting

Study contacts

  • Principal investigator: Kirby P Mayer, DPT, Ph.D. — University of Kentucky
  • Study coordinator: Doug Long, MS
  • Email: delong2@uky.edu
  • Phone: 859-218-0596

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.