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Effect of an intensive 3-week preoperative home rehabilitation programme in patients with chronic obstructive pulmonary disease eligible for lung cancer surgery: a multicentre randomised controlled trial

Authors :
Marc Filaire
Géraud Galvaing
Emmanuel Coudeyre
Sylvie Aubreton
Frédéric Costes
Ruddy Richard
Emilie Thivat
Hélène Laurent
Fabrice Kwiatkowski
Pôle IRAuS
Axe Images et Vision
Laboratoire Pluridisciplinaire de Recherche en Ingénierie des Systèmes, Mécanique et Energétique (PRISME)
Université d'Orléans (UO)-Ecole Nationale Supérieure d'Ingénieurs de Bourges (ENSI Bourges)-Université d'Orléans (UO)-Ecole Nationale Supérieure d'Ingénieurs de Bourges (ENSI Bourges)
service de chirurgie thoracique et endocrinienne
Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP)
UNICANCER-UNICANCER
Imagerie Moléculaire et Stratégies Théranostiques (IMoST)
Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])
UNICANCER
CHU Gabriel Montpied [Clermont-Ferrand]
CHU Clermont-Ferrand
Unité de Nutrition Humaine (UNH)
Institut National de la Recherche Agronomique (INRA)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])
service de recherche clinique
Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne)
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
Imagerie Moléculaire et Stratégies Théranostiques - Clermont Auvergne (IMoST)
Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA)
Centre Jean Perrin
CRLCC Jean Perrin
CHU Gabriel Montpied (CHU)
Unité de Nutrition Humaine - Clermont Auvergne (UNH)
Institut National de la Recherche Agronomique (INRA)-Université Clermont Auvergne (UCA)
Source :
BMJ Open, BMJ Open, BMJ Publishing Group, 2017, 7 (11), pp.e017307. ⟨10.1136/bmjopen-2017-017307⟩, BMJ Open, 2017, 7 (11), pp.e017307. ⟨10.1136/bmjopen-2017-017307⟩, BMJ Open, BMJ Publishing Group, 2017, 7 (11), ⟨10.1136/bmjopen-2017-017307⟩
Publication Year :
2017
Publisher :
BMJ Publishing Group, 2017.

Abstract

IntroductionSurgery is the standard curative treatment for lung cancer but is only possible in patients with local tumour and preserved exercise capacity. Improving fitness before surgery can reduce postoperative complications and mortality. However, preoperative rehabilitation remains difficult to implement for several reasons. We aim to investigate the effectiveness of an intensive 3-week home-based preoperative exercise training programme on hospital discharge ability, postoperative complications and physical performance in patients with chronic obstructive pulmonary disease (COPD) who are eligible for lung cancer surgery.Methods and analysisWe designed a multicentre randomised controlled trial. The randomisation sequence will be generated and managed electronically by a research manager independent of assessments or interventions. We will recruit 90 patients with COPD and a diagnosis of lung cancer from four university hospitals. The rehabilitation group (R group) will receive a standardised preoperative home exercise programme for 3 weeks, combining both high-intensity training and usual physical therapy. The R group will perform 15 training sessions over 3 weeks on a cycloergometer. A physical therapist experienced in pulmonary rehabilitation will visit the patient at home and supervise one session a week. The R group will be compared with a control group receiving preoperative usual physical therapy only. The primary outcome will be hospital discharge ability assessed with a 10-item list. Secondary outcomes will be postoperative course (complication rate and mortality) as well as pulmonary function, exercise capacity and quality of life assessed 1 month before and the day before surgery.Ethics and disseminationThis protocol has been approved by the French health authority for research (2016-A00622-49) and the research ethics committee/institutional review board (AU1267). Adverse events that occur during the protocol will be reported to the principal investigator. The results will be published in an international peer-reviewed journal.Trial registration numberNCT03020251.

Details

Language :
English
ISSN :
20446055
Volume :
7
Issue :
11
Database :
OpenAIRE
Journal :
BMJ Open
Accession number :
edsair.doi.dedup.....b43a8b562106ab6fd847348ce9942126
Full Text :
https://doi.org/10.1136/bmjopen-2017-017307⟩