Recovery of Physical Function After Critical Illness In Older Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sepsis, Acute Lung Injury(ALI). Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
RETURN: Recovery of Physical Function After Critical Illness In Older Adults
Overview
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.
Detailed description
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:
Aim 1: Determine the long-term trajectory of muscle strength, physical function and ADL recovery in ICU survivors. Patients (n = 150) will participate in a battery of tests to determine muscle and physical function aligned with self-reported measures of ADLs and quality of life at hospital discharge, 3-, 6-, 12-, and 24-months post.
Aim 2: Assess cellular changes in skeletal muscle in ICU survivors contributing to long-term physical dysfunction. In a subgroup of patients enrolled in Aim 1, muscle biopsies will be collected at baseline and long-term follow-up to determine oxidative stress, mitochondrial function, and cellular senescence.
Primary outcome measures
- 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.]
Secondary outcome measures (12)
- Muscle morphology # 1 [Time frame: Percent change from baseline to 12 months]
- Muscle morphology #2 [Time frame: Percent change from baseline to 12 months]
- Lower-extremity Muscle Power [Time frame: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
- Muscle Size and Quality measured by Ultrasound [Time frame: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
- Activities of Daily Living (ADL) [Time frame: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
- Health Reported Quality of Life [Time frame: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
- Fatigue [Time frame: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
- Physical Frailty [Time frame: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
- Physical Activity [Time frame: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
- Muscle strength of quadriceps [Time frame: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
- Grip Strength [Time frame: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
- Physical function [Time frame: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Kentucky, Lexington, Kentucky 40536 — Lexington
Identifiers
NCT: NCT07225257 · 106867