PUREAIR protocol: randomized controlled trial of intensive pulmonary rehabilitation versus standard care in patients undergoing surgical resection for lung cancer

BMC Cancer

Study Protocol

Roberta Bardelli¹  Stefania Fugazzaro¹  Patricia Filipa Sobral Rebelo¹  Carlotta Mainini¹  Besa Kopliku¹  Stefania Costi²  Roberto Piro³  Domenico Franco Merlo⁴  Silvio Cavuto⁴  Carla Galeone⁵  Sara Tenconi⁵  Tommaso Ricchetti⁵  Massimiliano Paci⁵  Giorgio Sgarbi⁵  Filippo Lococo⁵  Cristian Rapicetta⁵ 

[1] Physical Medicine and Rehabilitation Unit - Arcispedale Santa Maria Nuova-IRCCS, Viale Risorgimento 80, 42123, Reggio Emilia, Italy;Physical Medicine and Rehabilitation Unit - Arcispedale Santa Maria Nuova-IRCCS, Viale Risorgimento 80, 42123, Reggio Emilia, Italy;Department of Surgery, Medicine, Dentistry and Morphological Sciences, University of Modena and Reggio Emilia, Via del Pozzo n°71, 41124, Modena, Italy;Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal Child Health, University of Genoa, L.go P. Daneo n°3, 16132, Genoa, Italy;Pulmonology Unit - Arcispedale Santa Maria Nuova-IRCCS, Viale Risorgimento 80, 42123, Reggio Emilia, Italy;Research and Statistics Infrastructure Unit, Arcispedale Santa Maria Nuova-IRCCS, Viale Umberto I n°50, 42123, Reggio Emilia, Italy;Unit of Thoracic Surgery - Arcispedale Santa Maria Nuova-IRCCS, Viale Risorgimento 80, 42123, Reggio Emilia, Italy;

关键词: Rehabilitation;    Lung neoplasms;    Exercise therapy;    Patient education;    Breathing exercises;    Exercise tolerance;    Quality of life;    Patient compliance;   

DOI  :  10.1186/s12885-017-3479-y

 received in 2017-06-01, accepted in 2017-07-10,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundNon-small cell lung cancer is the most common type of lung cancer. Surgery is proven to be the most effective treatment in early stages, despite its potential impact on quality of life. Pulmonary rehabilitation, either before or after surgery, is associated with reduced morbidity related symptoms and improved exercise capacity, lung function and quality of life.MethodsWe describe the study protocol for the open-label randomized controlled trial we are conducting on patients affected by primary lung cancer (stages I-II) eligible for surgical treatment. The control group receives standard care consisting in one educational session before surgery and early inpatient postoperative physiotherapy. The treatment group receives, in addition to standard care, intensive rehabilitation involving 14 preoperative sessions (6 outpatient and 8 home-based) and 39 postoperative sessions (15 outpatient and 24 home-based) with aerobic, resistance and respiratory training, as well as scar massage and group bodyweight exercise training.Assessments are performed at baseline, the day before surgery and one month and six months after surgery. The main outcome is the long-term exercise capacity measured with the Six-Minute Walk Test; short-term exercise capacity, lung function, postoperative morbidity, length of hospital stay, quality of life (Short Form 12), mood disturbances (Hospital Anxiety and Depression Scale) and pain (Numeric Rating Scale) are also recorded and analysed. Patient compliance and treatment-related side effects are also collected. Statistical analyses will be performed according to the intention-to-treat approach. T-test for independent samples will be used for continuous variables after assessment of normality of distribution. Chi-square test will be used for categorical variables. Expecting a 10% dropout rate, assuming α of 5% and power of 80%, we planned to enrol 140 patients to demonstrate a statistically significant difference of 25 m at Six-Minute Walk Test.DiscussionPulmonary Resection and Intensive Rehabilitation study (PuReAIR) will contribute significantly in investigating the effects of perioperative rehabilitation on exercise capacity, symptoms, lung function and long-term outcomes in surgically treated lung cancer patients. This study protocol will facilitate interpretation of future results and wide application of evidence-based practice.Trial registrationClinicalTrials.gov Registry n. NCT02405273 [31.03.2015].

【 授权许可】

CC BY   
© The Author(s). 2017