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Rehabilitation for lung cancer patients undergoing surgery: results of the PUREAIR randomized trial [with consumer summary]
Tenconi S, Mainini C, Rapicetta C, Braglia L, Galeone C, Cavuto S, Merlo DF, Costi S, Paci M, Piro R, Fugazzaro S
European Journal of Physical and Rehabilitation Medicine 2021 Dec;57(6):1002-1011
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 center, unblinded, designed for superiority, 1:1 randomized controlled trial with two parallel arms. SETTING: S. Maria Nuova Hospital of Reggio Emilia (Reggio Emilia, Italy). POPULATION: Patients referred from local lung cancer multidisciplinary team for lung resection. METHODS: Patients were randomized to either standard of care (SC) or SC plus 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 meters 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 meters versus -7.5 meters respectively, difference: +56.4 meters, 95% CI 29.6 to 83.0, p < 0.001) and it showed significantly lower impairment at 1 month after surgery in the intervention group (-3.0 meters versus -30.1 meters difference: +27.1 meters, 95% CI 3.4 to 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.

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