Background Early physical rehabilitation in the intensive care unit (ICU) has been shown to improve short-term clinical outcomes but long-term benefit has not been proven and the optimum intensity of rehabilitation is not known.
Methods We conducted a randomised, parallel-group, allocation-concealed, assessor-blinded, controlled trial in patients who had received at least 48 hours of invasive or non-invasive ventilation. Participants were randomised in a 1:1 ratio, stratified by admitting ICU, admission type and level of independence. The intervention group had a target of 90 min physical rehabilitation per day, the control group a target of 30 min per day (both Monday to Friday). The primary outcome was the Physical Component Summary (PCS) measure of SF-36 at 6 months.
Results We recruited 308 participants over 34 months: 150 assigned to the intervention and 158 to the control group. The intervention group received a median (IQR) of 161 (67–273) min of physical rehabilitation on ICU compared with 86 (31–139) min in the control group. At 6 months, 62 participants in the intervention group and 54 participants in the control group contributed primary outcome data. In the intervention group, 43 had died, 11 had withdrawn and 34 were lost to follow-up, while in the control group, 56 had died, 5 had withdrawn and 43 were lost to follow-up. There was no difference in the primary outcome at 6 months, mean (SD) PCS 37 (12.2) in the intervention group and 37 (11.3) in the control group.
Conclusions In this study, ICU-based physical rehabilitation did not appear to improve physical outcomes at 6 months compared with standard physical rehabilitation.
Trial registration number ISRCTN 20436833.
- critical care
- early mobilisation
- mechanical ventilation
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Contributors SVB and CB conceived the study. SEW, CB, TJC, JW, LM and SVB designed the study, obtained funding and contributed to analysis and interpretation of data. AB and JS undertook the statistical and health economic analyses and contributed to the interpretation of data. The study was delivered at the sites by KT, VS, CW, JF, AH, KH and PH with oversight by local principal investigators AR, SB, SEW and SVB. RW provided data management and administrative support for the trial. GW was Trial Manager and JW Senior Trial Manager for the trial. SEW wrote the manuscript with input from the other authors. All authors critically reviewed the manuscript and approved the version to be published, SVB is guarantor.
Funding This project was supported by the Research for Patient Benefit Programme (RfPB) of the National Institute for Health Research; reference number PB-PG-0909-20021.
Disclaimer The views expressed in this article are those of the authors and do not necessarily reflect those of the RfPB Programme of the NIHR, the National Health Service or the Department of Health.
Competing interests None declared.
Patient consent Obtained.
Provenance and peer review Not commissioned; externally peer reviewed.
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