Exercise-based rehabilitation after hospital discharge for survivors of critical illness with intensive care unit-acquired weakness: A pilot feasibility trial.

PURPOSE: The aim of this study was to investigate feasibility of exercise-based rehabilitation delivered after hospital discharge in patients with intensive care unit-acquired weakness (ICU-AW). MATERIALS AND METHODS: Twenty adult patients, mechanically ventilated for more than 48 hours, with ICU-AW diagnosis at ICU discharge were included in a pilot feasibility randomized controlled trial receiving a 16-session exercise-based rehabilitation program. Twenty-one patients without ICU-AW participated in a nested observational cohort study. Feasibility, clinical, and patient-centered outcomes were measured at hospital discharge and at 3 months. RESULTS: Intervention feasibility was demonstrated by high adherence and patient acceptability, and absence of adverse events, but this must be offset by the low proportion of enrolment for those screened. The study was underpowered to detect effectiveness of the intervention. The use of manual muscle testing for the diagnosis of ICU-AW lacked robustness as an eligibility criterion and lacked discrimination for identifying rehabilitation requirements. Process evaluation of the trial identified methodological factors, categorized by "population," "intervention," "control group," and "outcome." CONCLUSIONS: Important data detailing the design, conduct, and implementation of a multicenter randomized controlled trial of exercise-based rehabilitation for survivors of critical illness after hospital discharge have been reported. REGISTRATION: Clinical Trials Identifier NCT00976807.