Recovery of Physical Function After Critical Illness In Older Adults
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorUniversity of Kentucky
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Adults with a diagnosis of acute lung injury or sepsis who have survived an Intensive Care Unit admission for at least 72 hours.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: RETURN
Trial outcomes
Primary outcomes
1
Muscle Strength measured by Chair Rise Test
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.
Time frame
Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.2
Functional Capacity
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.
Time frame
Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.Secondary outcomes
1
Muscle morphology # 1
Myofiber size
Time frame
Percent change from baseline to 12 months2
Muscle morphology #2
Myofiber type
Time frame
Percent change from baseline to 12 months3
Lower-extremity Muscle Power
Muscular Power: Power will be assessed using a linear potentiometer (HUMAC-360, CSMi, Stoughton, MA) to record the velocity and peak-velocity of a functional movement using a Shuttle MiniPress (Shuttle Systems, Bellingham, WA) as hamstring/gluteal pressdown. Outcome measure is Watts.
Time frame
Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.4
Muscle Size and Quality measured by Ultrasound
Ultrasound imaging will be performed to acquire images of quadriceps and tibialis anterior to measure muscle cross-sectional area, muscle thickness and echo intensity of muscles.
Time frame
Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.Sponsors and contacts
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Source ClinicalTrials.gov