A protocol for the rehabilitation of patients undergoing mechanical ventilation from the ICU to the post-hospital phase: the MOVE-ICUtoHOME, a multicentre randomised controlled trial

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INTRODUCTION: Intensive care unit-acquired weakness (ICU-AW) in patients with acute respiratory failure requiring invasive mechanical ventilation (IMV) is associated with reduced functional exercise capacity and increased mortality. Early mobilisation in the ICU may improve functional outcomes and reduce length of stay; however, evidence remains limited, protocols are heterogeneous and post-discharge rehabilitation is frequently lacking. This study aims to evaluate the effects of a continuous care programme combining early intensive ICU mobilisation with post-hospitalisation rehabilitation on functional exercise capacity, with inflammation, quality of life, mortality and cost-effectiveness as secondary outcomes in critically ill patients receiving IMV. METHODS AND ANALYSIS: This blinded, multicentre, randomised controlled trial will include adult patients undergoing invasive MV for at least 24 hours. Participants will be randomly allocated to one of four groups: intervention group (IG)-Rehab, control group (CG)-Rehab, IG-Home or CG-Home. During hospitalisation, the IG will receive an intensive mobilisation protocol (30-60 minutes/day), while the CG will receive routine care (up to 10 min/day). After hospital discharge, participants will undergo either 8 weeks of face-to-face rehabilitation (Rehab) or a home-based programme (Home), with follow-up for 6 months. Exploratory analyses will evaluate clinical parameters, severity indices, functional status, pulmonary function and mechanics, additional measures of functional exercise capacity, muscle strength and mass, energy expenditure, and symptoms of anxiety and depression. The 2×2 factorial design will allow for the evaluation of the independent effects of in-hospital mobilisation intensity and post-discharge rehabilitation strategy. Statistical analyses will use appropriate parametric or non-parametric tests, with significance set at p<0.05. ETHICS AND DISSEMINATION: The study will follow the Brazilian National Health Council guidelines, the Brazilian General Data Protection Law and Research Electronic Data Capture standards. Results will be disseminated through peer-reviewed journals, scientific meetings and social media. The trial is registered at ClinicalTrials.gov (NCT06405529; 8 May 2024) and follows Consolidated Standards of Reporting Trials guidelines.

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