Purpose: The aim of this study was to investigate feasibility of exercise-based rehabilitation delivered after hos- pital 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 diag- nosis 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 ad- verse events, but this must be offset by the low proportion of enrolment for those screened. The study was under- powered 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 con- trolled trial of exercise-based rehabilitation for survivors of critical illness after hospital discharge have been reported. Registration: Clinical Trials Identifier NCT00976807