Patients with acute respiratory failure who require invasive mechanical ventilation (IMV) are at risk of intensive care unit-acquired weakness (ICU-AW), which is linked to reduced functional exercise capacity and higher mortality. Although early mobilisation in the ICU can improve functional outcomes and shorten length of stay, existing evidence is limited, intervention protocols vary widely, and structured post-discharge rehabilitation is often absent. The MOVE-ICUtoHOME trial was developed to evaluate a continuous care approach that pairs an intensive in-hospital mobilisation protocol with a defined post-hospital rehabilitation strategy to improve longer-term functional recovery.
The MOVE-ICUtoHOME study is a blinded, multicentre, randomised controlled trial using a 2×2 factorial design. The factorial arrangement permits independent evaluation of two factors: the intensity of in-hospital mobilisation and the type of post-discharge rehabilitation (face-to-face versus home-based). The trial is described as multicentre and will follow participants for six months after hospital discharge.
The protocol enrols adult patients who undergo invasive mechanical ventilation for at least 24 hours. The source abstract does not report additional inclusion or exclusion criteria in detail; those specifics were not reported in the source excerpt.
Participants will be randomly allocated to one of four groups:
This allocation structure allows the study to separately assess the effect of more intensive in-hospital mobilisation and the effect of supervised face-to-face versus home-based post-discharge rehabilitation.
During hospitalisation, the intervention arms receive an intensive mobilisation protocol consisting of 30–60 minutes per day. The control arms receive routine care, defined in the abstract as up to 10 minutes per day. The protocol text in the abstract does not provide further operational detail on mobilisation content, progression criteria, or specific safety/feasibility measures; those details were not reported in the source excerpt.
After discharge, participants enter one of two post-hospital programmes for eight weeks: a face-to-face supervised rehabilitation programme (Rehab) or a home-based programme (Home). The trial includes follow-up to six months to evaluate sustained effects. The abstract does not provide granular content of the rehabilitation sessions, frequency, or specific exercises; those elements were not reported in the available source text.
The primary outcome is functional exercise capacity. Secondary outcomes include markers of inflammation, quality of life, mortality, and cost-effectiveness. The protocol also specifies exploratory analyses covering a broad set of clinical and physiologic variables: severity indices, functional status measures, pulmonary function and mechanics, additional functional exercise capacity measures, muscle strength and mass, energy expenditure, and symptoms of anxiety and depression. The abstract indicates that multiple clinical parameters will be evaluated but does not list specific scales, tests or timepoints beyond the 6-month follow-up; those details were not reported in the source excerpt.
The investigators will apply appropriate parametric or non-parametric statistical tests according to variable distributions, with statistical significance set at p<0.05. The factorial 2×2 design enables estimation of the independent effects of increased in-hospital mobilisation intensity and the post-discharge rehabilitation strategy. The abstract notes exploratory analyses but does not provide detailed sample size calculations, handling of missing data, or adjustment strategies; those specifics were not reported in the source excerpt.
The trial will adhere to the Brazilian National Health Council guidelines, the Brazilian General Data Protection Law, and Research Electronic Data Capture (REDCap) standards for data management. The study is registered on ClinicalTrials.gov (NCT06405529) and follows Consolidated Standards of Reporting Trials (CONSORT) guidance. Results are planned for dissemination through peer-reviewed journals, scientific meetings and social media. The published protocol in BMJ Open Respiratory Research declares no competing interests.
Notes on source limitations
The available source text is the published protocol abstract and metadata. Several operational details commonly included in full protocols—such as full eligibility criteria, sample size justification, exact rehabilitation session content and frequency, safety monitoring, and specific measurement instruments and timepoints—are not reported in the abstract provided and therefore are not included here.