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


Journal

European journal of physical and rehabilitation medicine
ISSN: 1973-9095
Titre abrégé: Eur J Phys Rehabil Med
Pays: Italy
ID NLM: 101465662

Informations de publication

Date de publication:
Dec 2021
Historique:
pubmed: 28 5 2021
medline: 24 12 2021
entrez: 27 5 2021
Statut: ppublish

Résumé

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. To establish whether intensive pulmonary rehabilitation, preoperative and postoperative, improves exercise capacity in patients undergoing lung resection. Single center, unblinded, designed for superiority, 1:1 randomized controlled trial with two parallel arms. S. Maria Nuova Hospital of Reggio Emilia (Reggio Emilia, Italy). Patients referred from local lung cancer multidisciplinary team for lung resection. Patients were randomized 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 meters in exercise tolerance, measured with 6 minutes walking test. The exercise tolerance at 6 months after surgery was significantly higher in patients undertaking PR compared to SC (+48.9 meters vs. -7.5 meters respectively, difference: +56.4 meters, 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 meters vs. -30.1 meters difference: +27.1 meters, 95% CI: 3.4-50.8, P=0.025). No other significant differences between groups were found. 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. The PUREAIR trial highlights the importance of combined preoperative and postoperative 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.

Sections du résumé

BACKGROUND 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 OBJECTIVE
To establish whether intensive pulmonary rehabilitation, preoperative and postoperative, improves exercise capacity in patients undergoing lung resection.
DESIGN METHODS
Single center, unblinded, designed for superiority, 1:1 randomized controlled trial with two parallel arms.
SETTING METHODS
S. Maria Nuova Hospital of Reggio Emilia (Reggio Emilia, Italy).
POPULATION METHODS
Patients referred from local lung cancer multidisciplinary team for lung resection.
METHODS METHODS
Patients were randomized 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 meters in exercise tolerance, measured with 6 minutes walking test.
RESULTS RESULTS
The exercise tolerance at 6 months after surgery was significantly higher in patients undertaking PR compared to SC (+48.9 meters vs. -7.5 meters respectively, difference: +56.4 meters, 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 meters vs. -30.1 meters difference: +27.1 meters, 95% CI: 3.4-50.8, P=0.025). No other significant differences between groups were found.
CONCLUSIONS 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 CONCLUSIONS
The PUREAIR trial highlights the importance of combined preoperative and postoperative 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.

Identifiants

pubmed: 34042410
pii: S1973-9087.21.06789-7
doi: 10.23736/S1973-9087.21.06789-7
doi:

Types de publication

Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

1002-1011

Auteurs

Sara Tenconi (S)

Unit of Thoracic Surgery, AUSL Reggio Emilia, Reggio Emilia, Italy.

Carlotta Mainini (C)

Unit of Physical Medicine and Rehabilitation, AUSL Reggio Emilia, Reggio Emilia, Italy - carlotta.mainini@ausl.re.it.

Cristian Rapicetta (C)

Unit of Thoracic Surgery, AUSL Reggio Emilia, Reggio Emilia, Italy.

Luca Braglia (L)

Unit of Research and Statistic Infrastructure, AUSL Reggio Emilia, Reggio Emilia, Italy.

Carla Galeone (C)

Unit of Pulmonology, Azienda USL - IRCCS di Reggio Emilia, Reggio Emilia, Italy.

Silvio Cavuto (S)

Unit of Research and Statistic Infrastructure, AUSL Reggio Emilia, Reggio Emilia, Italy.

Domenico F Merlo (DF)

Unit of Research and Statistic Infrastructure, AUSL Reggio Emilia, Reggio Emilia, Italy.

Stefania Costi (S)

Department of Surgery, Medicine, Dentistry and Morphological Sciences, University of Modena and Reggio Emilia, Modena, Italy.
Scientific Directorate, AUSL Reggio Emilia, Reggio Emilia, Italy.

Massimiliano Paci (M)

Unit of Thoracic Surgery, AUSL Reggio Emilia, Reggio Emilia, Italy.

Roberto Piro (R)

Unit of Pulmonology, Azienda USL - IRCCS di Reggio Emilia, Reggio Emilia, Italy.

Stefania Fugazzaro (S)

Unit of Physical Medicine and Rehabilitation, AUSL Reggio Emilia, Reggio Emilia, Italy.

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