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/