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

Stefania Fugazzaro, Stefania Costi, Carlotta Mainini, Besa Kopliku, Cristian Rapicetta, Roberto Piro, Roberta Bardelli, Patricia Filipa Sobral Rebelo, Carla Galeone, Giorgio Sgarbi, Filippo Lococo, Massimiliano Paci, Tommaso Ricchetti, Silvio Cavuto, Domenico Franco Merlo, Sara Tenconi

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: Non-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. Methods: We 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 25m at Six-Minute Walk Test. Discussion: Pulmonary 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 registration: ClinicalTrials.gov Registry n. NCT02405273[31.03.2015].

Original languageEnglish
Article number508
JournalBMC Cancer
Volume17
Issue number1
DOIs
Publication statusPublished - Jul 31 2017

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Lung Volume Measurements
Lung Neoplasms
Patient Care
Rehabilitation
Randomized Controlled Trials
Exercise
Lung
Quality of Life
Length of Stay
Outpatients
Morbidity
Exercise Therapy
Massage
Resistance Training
Evidence-Based Practice
Chi-Square Distribution
Therapeutics
Critical Care
Patient Compliance
Ambulatory Surgical Procedures

Keywords

  • Breathing exercises
  • Exercise therapy
  • Exercise tolerance
  • Lung neoplasms
  • Patient compliance
  • Patient education
  • Quality of life
  • Rehabilitation

ASJC Scopus subject areas

  • Oncology
  • Genetics
  • Cancer Research

Cite this

PUREAIR protocol : Randomized controlled trial of intensive pulmonary rehabilitation versus standard care in patients undergoing surgical resection for lung cancer. / Fugazzaro, Stefania; Costi, Stefania; Mainini, Carlotta; Kopliku, Besa; Rapicetta, Cristian; Piro, Roberto; Bardelli, Roberta; Rebelo, Patricia Filipa Sobral; Galeone, Carla; Sgarbi, Giorgio; Lococo, Filippo; Paci, Massimiliano; Ricchetti, Tommaso; Cavuto, Silvio; Merlo, Domenico Franco; Tenconi, Sara.

In: BMC Cancer, Vol. 17, No. 1, 508, 31.07.2017.

Research output: Contribution to journalArticle

Fugazzaro, Stefania ; Costi, Stefania ; Mainini, Carlotta ; Kopliku, Besa ; Rapicetta, Cristian ; Piro, Roberto ; Bardelli, Roberta ; Rebelo, Patricia Filipa Sobral ; Galeone, Carla ; Sgarbi, Giorgio ; Lococo, Filippo ; Paci, Massimiliano ; Ricchetti, Tommaso ; Cavuto, Silvio ; Merlo, Domenico Franco ; Tenconi, Sara. / PUREAIR protocol : Randomized controlled trial of intensive pulmonary rehabilitation versus standard care in patients undergoing surgical resection for lung cancer. In: BMC Cancer. 2017 ; Vol. 17, No. 1.
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AU - Costi, Stefania

AU - Mainini, Carlotta

AU - Kopliku, Besa

AU - Rapicetta, Cristian

AU - Piro, Roberto

AU - Bardelli, Roberta

AU - Rebelo, Patricia Filipa Sobral

AU - Galeone, Carla

AU - Sgarbi, Giorgio

AU - Lococo, Filippo

AU - Paci, Massimiliano

AU - Ricchetti, Tommaso

AU - Cavuto, Silvio

AU - Merlo, Domenico Franco

AU - Tenconi, Sara

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N2 - Background: Non-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. Methods: We 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 25m at Six-Minute Walk Test. Discussion: Pulmonary 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 registration: ClinicalTrials.gov Registry n. NCT02405273[31.03.2015].

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