Rehabilitation for lung cancer patients undergoing surgery: results of the PUREAIR randomized trial.

BACKGROUND Surgery for Non Small Cell Lung Cancer is proven to be the most effective treatment in early stages, although concerns exist on its negative impact on patients' overall fitness. AIM To establish whether intensive pulmonary rehabilitation, preoperative and postoperative, improves exercise capacity in patients undergoing lung resection. DESIGN Single centre, unblinded, designed for superiority, 1:1 randomised controlled trial with two parallel arms. SETTING S.Maria Nuova Hospital of Reggio Emilia (Italy). POPULATION Patients referred from local lung cancer multi-disciplinary team for lung resection. METHODS Patients were randomised to either standard of care (SC) or SC + intensive perioperative pulmonary rehabilitation (SC+PR). The primary aim was to investigate the effectiveness of pulmonary rehabilitation in improving exercise capacity six months after surgery. Additionally, we wanted to investigate the same effect shortly after surgery (at one month), as well as the overall impact of rehabilitation on lung function, postoperative complications and length of stay, Quality of Life, mood disturbances and pain. Sample was sized based on the primary outcome assuming a minimal clinically significant difference of 25 metres in exercise tolerance, measured with 6 minutes walking test. RESULTS The exercise tolerance at 6 months after surgery was significantly higher in patients undertaking PR compared to SC (+48.9 metres vs -7.5 metres respectively, difference: +56.4 metres, 95% CI: 29.6 - 83.0, p<0.001) and it showed significantly lower impairment at 1 month after surgery in the intervention group (-3.0 metres vs -30.1 metres difference: +27.1 metres, 95% CI: 3.4 - 50.8, p=0.025). No other significant differences between groups were found. CONCLUSIONS Comparison between groups showed that pulmonary rehabilitation, administered pre and postoperatively, significantly improved exercise capacity at 6 months in patients undergoing lung resection; it also significantly reduced the decrease in exercise tolerance observed 1 month after surgery. CLINICAL REHABILITATION IMPACT The PUREAIR trial highlights the importance of combined pre-operative and post-operative rehabilitation in reducing physical deconditioning in lung cancer patients undergoing surgery. Comprehensive pulmonary rehabilitation improves exercise capacity at 1 and 6 months after surgery. The PUREAIR trial results increase knowledge on comprehensive rehabilitation's outcomes in the first six months after surgery.