Multicentre randomized clinical trial of inspiratory muscle training versus usual care before surgery for oesophageal cancer
Valkenet, K.; Trappenburg, J. C.A.; Ruurda, J. P.; Guinan, E. M.; Reynolds, J. V.; Nafteux, P.; Fontaine, M.; Rodrigo, H. E.; van der Peet, D. L.; Hania, S. W.; Sosef, M. N.; Willms, J.; Rosman, C.; Pieters, H.; Scheepers, J. J.G.; Faber, T.; Kouwenhoven, E. A.; Tinselboer, M.; Räsänen, J.; Ryynänen, H.; Gosselink, R.; van Hillegersberg, R.; Backx, F. J.G.
(2018) British Journal of Surgery, volume 105, issue 5, pp. 502 - 511
(Article)
Abstract
Background: Up to 40 per cent of patients undergoing oesophagectomy develop pneumonia. The aim of this study was to assess whether preoperative inspiratory muscle training (IMT) reduces the rate of pneumonia after oesophagectomy. Methods: Patients with oesophageal cancer were randomized to a home-based IMT programme before surgery or usual care.
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IMT included the use of a flow-resistive inspiratory loading device, and patients were instructed to train twice a day at high intensity (more than 60 per cent of maximum inspiratory muscle strength) for 2 weeks or longer until surgery. The primary outcome was postoperative pneumonia; secondary outcomes were inspiratory muscle function, lung function, postoperative complications, duration of mechanical ventilation, length of hospital stay and physical functioning. Results: Postoperative pneumonia was diagnosed in 47 (39·2 per cent) of 120 patients in the IMT group and in 43 (35·5 per cent) of 121 patients in the control group (relative risk 1·10, 95 per cent c.i. 0·79 to 1·53; P = 0·561). There was no statistically significant difference in postoperative outcomes between the groups. Mean(s.d.) maximal inspiratory muscle strength increased from 76·2(26·4) to 89·0(29·4) cmH 2O (P < 0·001) in the intervention group and from 74·0(30·2) to 80·0(30·1) cmH 2O in the control group (P < 0·001). Preoperative inspiratory muscle endurance increased from 4 min 14 s to 7 min 17 s in the intervention group (P < 0·001) and from 4 min 20 s to 5 min 5 s in the control group (P = 0·007). The increases were highest in the intervention group (P < 0·050). Conclusion: Despite an increase in preoperative inspiratory muscle function, home-based preoperative IMT did not lead to a decreased rate of pneumonia after oesophagectomy. Registration number: NCT01893008 (https://www.clinicaltrials.gov).
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Keywords: Esophageal Neoplasms/surgery, Esophagectomy, Exercise Therapy/methods, Female, Follow-Up Studies, Humans, Incidence, Male, Middle Aged, Netherlands/epidemiology, Pneumonia/epidemiology, Postoperative Complications/epidemiology, Preoperative Care/methods, Respiratory Muscles/physiopathology, Single-Blind Method, Treatment Outcome, Surgery, Randomized Controlled Trial, Multicenter Study, Journal Article
ISSN: 0007-1323
Publisher: John Wiley & Sons Inc.
Note: Funding Information: The authors thank all other involved persons who provided and cared for study patients, and collected data: C. Forde, S. Doyle, J. Gannon, L. O'Neil, N. Charususin, A. de Kuijer, L. van Hillege, C. Schippers, S. van der Horst, G. Heijnen, E. de Graaf, S. de Heus, W. van den Bos, J. van Rhijn, I. Stohr, C. Wiedenbach, M. Kerkemeyer, N. de Vries, C. Merkx, C. Huibers, E. Geleijn and M. Rasanen. They also thank all other involved staff from participating centres: Trinity Centre for Health Sciences (Wellcome Trust/Health Research Board Clinical Research Facility), St James's Hospital, Dublin, Ireland; University Hospital Gasthuisberg, Leuven, Belgium; Reinier de Graaf Hospital, Delft, The Netherlands; ZGT Hospital Group, Almelo, The Netherlands; Canisius Wilhelmina Hospital, Nijmegen, The Netherlands; Helsinki University Central Hospital, Helsinki, Finland; VU University Medical Centre, Amsterdam, The Netherlands; Zuyderland Medical Centre, Heerlen, The Netherlands; and University Medical Centre Utrecht (the coordinating centre), Utrecht, The Netherlands. The PREPARE trial received funding from Fund NutsOhra (1202-013) and Friends of UMC Utrecht Foundation (11-078). Neither fund had any role in the design or conduct of the study; collection, management, analysis or interpretation of data; preparation, review or approval of the manuscript; or decision to submit the manuscript for publication. Disclosure: The authors declare no conflict of interest. Funding Information: The PREPARE trial received funding from Fund Nuts-Ohra (1202-013) and Friends of UMC Utrecht Foundation (11-078). Neither fund had any role in the design or conduct of the study; collection, management, analysis or interpretation of data; preparation, review or approval of the manuscript; or decision to submit the manuscript for publication. Disclosure: The authors declare no conflict of interest. Publisher Copyright: © 2018 BJS Society Ltd Published by John Wiley & Sons Ltd
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