Effect of supervised aerobic exercise rehabilitation on physical fitness and quality-of-life in survivors of critical illness: an exploratory minimized controlled trial (PIX study)

BACKGROUND Evidence is limited for the effectiveness of interventions for survivors of critical illness after hospital discharge. We explored the effect of an 8-week hospital-based exercise-training programme on physical fitness and quality-of-life. METHODS In a parallel-group minimized controlled trial, patients were recruited before hospital discharge or in the intensive care follow-up clinic and enrolled 8-16 weeks after discharge. Each week, the intervention comprised two sessions of physiotherapist-led cycle ergometer exercise (30 min, moderate intensity) plus one equivalent unsupervised exercise session. The control group received usual care. The primary outcomes were the anaerobic threshold (in ml O2 kg(-1) min(-1)) and physical function and mental health (SF-36 questionnaire v.2), measured at Weeks 9 (primary time point) and 26. Outcome assessors were blinded to group assignment. RESULTS Thirty patients were allocated to the control and 29 to the intervention. For the anaerobic threshold outcome at Week 9, data were available for 17 control vs 13 intervention participants. There was a small benefit (vs control) for the anaerobic threshold of 1.8 (95% confidence interval, 0.4-3.2) ml O2 kg(-1) min(-1). This advantage was not sustained at Week 26. There was evidence for a possible beneficial effect of the intervention on self-reported physical function at Week 9 (3.4; -1.4 to 8.2 units) and on mental health at Week 26 (4.4; -2.4 to 11.2 units). These potential benefits should be examined robustly in any subsequent definitive trial. CONCLUSIONS The intervention appeared to accelerate the natural recovery process and seems feasible, but the fitness benefit was only short term. CLINICAL TRIAL REGISTRATION Current Controlled Trials ISRCTN65176374 (http://www.controlled-trials.com/ISRCTN65176374).