Critically-ill patients with liver disease are at high risk of developing sarcopenia and intensive care unit (ICU)-acquired weakness, which are associated with mortality and other poor outcomes. Early physical rehabilitation has shown benefit in ICU settings, but has not been studied in ICU patients with acute and chronic liver failure. Cycle ergometry, or stationary cycling in passive and active modes, may be especially beneficial to such patients due to their high prevalence of severe physical deconditioning and variable mentation. The aim of this study is to examine the feasibility, safety, and benefit of cycle ergometry over standard physical and occupational therapy (PT/OT) in critically-ill patients who have acute or chronic liver disease.
A single-blinded randomized controlled trial will be conducted in a transplant intensive care unit (TICU). Eligible adult patients will be enrolled within 72 hrs after TICU admission and randomly allocated to either (1) standard PT/OT care, or (2) PT/OT care and cycle ergometry sessions with trained PT/OT therapists or technicians. The outcome measures, tests of strength and function, will be assessed at baseline, every 14 days, and upon TICU discharge by a blinded PT/OT therapist.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
97
Lower extremity cycle ergometry, passive and/or active, up to 20 minutes per session, up to 5 sessions per week
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Functional Status Score for the Intensive Care Unit (FSS-ICU)
Standardized assessment tool for functional status in ICU patients. Score ranges from 0 (unable to perform) to 35 (highest function).
Time frame: Through study completion, average of 1 year
Number of participants who experience an adverse event during therapy
Total number of participants who experience an adverse event during PT/OT and cycling sessions during course of study
Time frame: Through study completion, average of 1 year
Duration of mechanical ventilation
Average number of days on mechanical ventilation
Time frame: Through study completion, average of 1 year
ICU length of stay
Average length of stay in days
Time frame: Through study completion, average of 1 year
Number of participants who experience ICU readmission
Total number of participants readmitted to ICU during study period
Time frame: Through study completion, average of 1 year
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