Objective To investigate the effectiveness of a 6-week exercise programme in patients discharged home following critical illness compared with standard care.
Design Multicentre prospective phase II randomised controlled trial, with blinded outcome assessment after hospital discharge, following the 6-week intervention and at 6 months.
Participants 60 patients (30 per group) aged ≥18 years, mechanically ventilated >96 hours, and not in other rehabilitation, that is, cardiac or pulmonary rehabilitation programmes. Participants in the intervention group completed an individually tailored (personalised) exercise programme.
Outcome measures Primary outcome measure was SF-36 physical functioning following the intervention. Secondary outcomes included a range of performance-based and patient-reported measures.
Results Improvements in the primary outcome did not differ significantly between groups (mean difference (95% CI) 3.0 (−2.2 to 8.2), p=0.26). The intervention group showed significant improvement compared with the control group (mean difference (95% CI)) in SF-36 role physical (6.6 (0.73 to 12.5), p=0.03); incremental shuttle walk test (83.1 m (8.3 to 157.9), p=0.03); functional limitations profile (−4.8 (−8.7 to −0.9), p=0.02); self-efficacy to exercise (2.2 (0.8 to 3.7), p=0.01) and readiness to exercise (1.3 (0.8 to 1.9), p<0.001). These improvements were not sustained at 6 months except readiness to exercise. Improvements in all other secondary outcome measures were not significant.
Conclusions There was no statistically significant difference in the primary outcome measure of self-reported physical function following this 6-week exercise programme. Secondary outcome results will help inform future studies.
Trial registration number NCT01463579. (results), https://clinicaltrials.gov/
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For the trial protocol, see http://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-15-146
Contributors KMcD and BO'N are joint first authors. DFMcA and JMB are joint senior authors. KMcD, BO'N , BB, DFMcA and JMB contributed substantially to the study design, data acquisition, data analysis and interpretation, and the writing or revision of the manuscript. Original study concept was by DFMcA, SM, GL, JMB and BO'N. EG was the trial statistician. BO'N was chief investigator. BM was principal investigator (PI) at Royal Victoria Hospital; MK was PI at Altnagelvin Area Hospital; PJ was PI at Antrim Area Hospital; CC was PI at Craigavon Area Hospital; TJT was PI at Ulster Hospital; and JMcC was PI at Belfast City Hospital. All authors contributed to the revision of the manuscript and approved the final manuscript for submission.
Funding REVIVE, a charity of the Regional Intensive Care Unit, Northern Ireland. Additional funding provided by the Health and Social Care Research and Development Office, Northern Ireland. This trial was also supported by the Northern Ireland Clinical Research Network (NICRN) (Critical Care and Respiratory Health interest groups) and the Northern Ireland Clinical Trials Unit (NICTU), a UK Clinical Research Collaboration (UKCRC) registered clinical trials unit.
Competing interests None declared.
Patient consent Obtained.
Ethics approval The REVIVE trial was approved by the Northern Ireland Research Ethics Committee (ORECNI) (11/NI/0115).
Provenance and peer review Not commissioned; externally peer reviewed.