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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
  1. Hélène Laurent1,2,
  2. Géraud Galvaing3,
  3. Emilie Thivat4,5,
  4. Emmanuel Coudeyre1,2,
  5. Sylvie Aubreton2,
  6. Ruddy Richard1,6,
  7. Fabrice Kwiatkowski4,5,
  8. Frederic Costes1,6,
  9. Marc Filaire1,3
  1. 1INRA, Unité de Nutrition Humaine (UNH), Université Clermont Auvergne, CRNH Auvergne, Clermont-Ferrand, France
  2. 2Service de Médecine Physique et Réadaptation, Centre Hospitalier Universitaire Clermont-Ferrand, Clermont-Ferrand, France
  3. 3Service de Chirurgie Thoracique et Endocrinienne, Centre Jean Perrin, Clermont-Ferrand, France
  4. 4INSERM, U1240, Imagerie Moléculaire et Stratégies Théranostiques, Université Clermont Auvergne, Clermont-Ferrand, France
  5. 5Direction de la Recherche Clinique, Centre Jean Perrin, Clermont-Ferrand, France
  6. 6Service de Médecine du Sport et des Explorations Fonctionnelles, CHU Clermont-Ferrand, Clermont-Ferrand, France
  1. Correspondence to Hélène Laurent; hlaurent{at}chu-clermontferrand.fr

Abstract

Introduction Surgery 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 analysis We 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 dissemination This 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 number NCT03020251.

  • exercise
  • lung resection
  • physical therapy
  • postoperative complication
  • rehabilitation

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors HL, RR, FK, FC and MF designed the study and wrote the protocol. GG, ET, EC and SA read and corrected the drafts. HL, FK, FC, MF, GG and ET collected and managed the data. HL, FK, FC, MF, GG and ET analysed and interpreted the data.

  • Funding This work was supported by the French Health Ministry (Programme Hospitalier de Recherche Clinique Interrégional of Rhône-Alpes Auvergne).

  • Competing interests None declared.

  • Ethics approval The study protocol was approved by the French regulatory authority for research (Agence Nationale de Sécurité du Médicament et des Produits de Santé, registration no. 2016-A00622-49) and the Research Ethics Committee/Institutional Review Board (REC/IRB: Comité de Protection des Personnes Sud-Est VI France, Human Research Ethics approval no. AU1267).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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