Internet-based perioperative exercise program in patients with Barrett's carcinoma scheduled for esophagectomy [iPEP - study] a prospective randomized-controlled trial

Daniel Pfirrmann, Suzan Tug, Oana Brosteanu, Matthias Mehdorn, Martin Busse, Peter P Grimminger, Florian Lordick, Torben Glatz, Jens Hoeppner, Hauke Lang, Perikles Simon, Ines Gockel, Daniel Pfirrmann, Suzan Tug, Oana Brosteanu, Matthias Mehdorn, Martin Busse, Peter P Grimminger, Florian Lordick, Torben Glatz, Jens Hoeppner, Hauke Lang, Perikles Simon, Ines Gockel

Abstract

Background: Patients undergoing surgery for esophageal cancer have a high risk for postoperative deterioration of lung function and pulmonary complications. This is partly due to one-lung ventilation during thoracotomy. This often accounts for prolonged stay on intensive care units, delayed postoperative reconvalescence and reduced quality of life. Socioeconomic disadvantages can result from these problems. Physical preconditioning has become a crucial leverage to optimize fitness and lung function in patients scheduled for esophagectomy, in particular during the time period of neoadjuvant therapy.

Methods/study design: We designed a prospective multicenter randomized-controlled trial. The objective is to evaluate the impact of an internet-based exercise program on postoperative respiratory parameters and pneumonia rates in patients with Barrett's carcinoma scheduled for esophagectomy. Patients are randomly assigned to either execute internet-based perioperative exercise program (iPEP), including daily endurance, resistance and ventilation training or treatment as usual (TAU). During neoadjuvant therapy and recovery, patients in the intervention group receive an individually designed intensive exercise program based on functional measurements at baseline. Personal feedback of the supervisor with customized training programs is provided in weekly intervals.

Discussion: This study will evaluate if an intensive individually adapted training program via online supervision during neoadjuvant therapy will improve cardiorespiratory fitness and reduce pulmonary complications following esophagectomy for Barrett's cancer.

Trial registration: NCT02478996 , registered 26 May 2015.

Keywords: Exercise; Internet-based; Oesophageal cancer; Perioperative.

Figures

Fig. 1
Fig. 1
Criteria of training customization
Fig. 2
Fig. 2
Time course of interventions (iPEP and TAU)

References

    1. Gockel I, Niebisch S, Ahlbrand CJ, Hoffmann C, Moehler M, Düber C, Lang H, Heid. F: Risk and complication management in esophageal cancer surgery: A review of the literature. Thorac Cardiovasc Surg 2015, 00:1–10.
    1. van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; : Perioperative chemoradiotherapy for esophageal or junctional cancer. New Engl J Med 2012, 366:2074–2084.
    1. Derogar M, Orsini N, Sadr-Azodi O, Lagergren P. Influence of major postoperative complications on health-related quality of life among long-term survivors of esophageal cancer surgery. J Clin Oncol. 2012;30:1615–1619. doi: 10.1200/JCO.2011.40.3568.
    1. Biere SS, van Berge Henegouwen MI, Maas KI, Bonavina L, Rosman C, Garcia JR, Gisbertz SS, Klinkenbijl JH, Hollmann MW, de Lange ES, Bonjer HJ, van der Peet DL, Cuesta MA. Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicenter, open-labeled, randomized controlled trial. Lancet. 2012;379:1887–1892. doi: 10.1016/S0140-6736(12)60516-9.
    1. Schwenk W. Fast track rehabilitation in visceral surgery. Chirurg. 2009;80:690–701. doi: 10.1007/s00104-009-1676-1.
    1. Bardam L, Funch-Jensen P, Jensen P, Crawford ME, Kehlet H. Recovery after laparoscopic colinic surgery with epidural analgesia, and early oral nutrition and mobilisation. Lancet. 1995;345:763–764. doi: 10.1016/S0140-6736(95)90643-6.
    1. Cerfolio RJ, Bryant AS, Bass CS, Alexander JR, Bartolucci AA. Fast tracking after Ivor Lewis esophagectomy. Chest. 2004;126:1187–1194. doi: 10.1378/chest.126.4.1187.
    1. Jianjun Q, Yin L, Wenqun X, Ming Y, Qingfeng J. Fast track program for esophagectomy patients. Thoracic Cancer. 2012;3:55–59. doi: 10.1111/j.1759-7714.2011.00081.x.
    1. Cao S, Zhao G, Cui J, Dong Q, Qi S, Xin Y, Shen B, Guo Q. Fast-track rehabilitation program and conventional care after esophagectomy: a retrospective controlled cohort study. Support Care Cancer. 2012;21:707–714. doi: 10.1007/s00520-012-1570-0.
    1. Jensen LS, Pilegaard HK, Eliasen M, Mehlsen NC, Kehlet H. Esophageal resection in an accelerated postoperative recovery regimen. Ugeskr Laeger. 2004;166:2560–2563.
    1. Neal JM, Wilcox RT, Allen HW, Low DE. Near-total esophagectomy: the influence of standardized multimodal management and intraoperative fluid restriction. Reg Anesth Pain Med. 2003;28:328–334.
    1. Blom RLGM, van Heijl M, Bemelman WA, Hollmann MW, Klinkenbijl JHG, Busch ORC, van Berge Henegouwen MI. Initial experiences of an enhanced recovery protocol in esophageal surgery. World J Surg. 2013;37:2372–2378. doi: 10.1007/s00268-013-2135-1.
    1. Valkenet K, van de Port IGL, Dronkers JJ, de Vries WR, Lindemann E, Backx FJG. The effects of preoperative exercise therapy on postoperative outcome: a systematic review. Clin Rehabil. 2011;25:99–111. doi: 10.1177/0269215510380830.
    1. Feeney C, Reynolds JV, Hussey J. Preoperative physical activity levels and postoperative pulmonary complications post-esophagectomy. Dis Esophagus. 2011;24:489–494. doi: 10.1111/j.1442-2050.2010.01171.x.
    1. Tatematsu N, Park M, Tanaka E, Sakai Y, Tsuboyama T. Association between physical activity and postoperative complications after esophagectomy for cancer: a prospective observational study. Asian Pacific J Cancer Prev. 2013;14:47–51. doi: 10.7314/APJCP.2013.14.1.47.
    1. van Adrichem EJ, Meulenbroek RL, Plukker JTM, Groen H, van Weert E. Comparison of two preoperative inspiratory muscle training programs to prevent pulmonary complications in patients undergoing esophagectomy: a randomized controlled pilot study. Ann Surg Oncol. 2014;21:2353–2360.
    1. Dettling DS, van der Schaaf M, Blom RLGM, Nollet F, Busch ORC, van Berge Henegouwen MI. Feasibility and effectiveness of pre-operative inspiratory muscle training in patients undergoing oesophagectomy: a pilot study. Physiother Res Int. 2013;18:16–26. doi: 10.1002/pri.1524.
    1. Agrelli TF, de Carvalho RM, Guglielminetti R, Silva AA, Crema E. Preoperative ambulatory inspiratory muscle training in patients undergoing esophagectomy. A pilot study. Int Surg. 2012;97:198–202. doi: 10.9738/CC136.1.
    1. Inoue J, Ono R, Makiura D, Kashiwa-Motoyama M, Miura Y, Usami M, Nakamura T, Imanishi T, Kuroda D. Prevention of postoperative pulmonary complications through intensive preoperative respiratory rehabilitation in patients with esophageal cancer. Dis Esophagus. 2013;26:68–74. doi: 10.1111/j.1442-2050.2012.01336.x.
    1. Valkenet K, Trappenburg JCA, Gosselink R, Sosef MN, Willms J, Rosman C, Pieters H, Scheepers JJG, de Heus SC, Reynolds JV, Guinan E, Ruurda JP, Rodrigo EHE, Nafteux P, Fontaine M, Kouwenhoven EA, Kerkemeyer M, van der Peet DL, Hania SW, van Hillegersberg R, Backx FJG. Preoperative inspiratory muscle training to prevent postoperative pulmonary complications in patients undergoing esophageal resection (PREPARE study): study protocol for a randomized controlled trial. Trials. 2014;15:144. doi: 10.1186/1745-6215-15-144.
    1. Random Numbers Info. website /.
    1. Kondrup J, Allison S, Elia M, Vellas B, Plauth M. ESPEN guidelines for nutrition screening 2002. Clin Nutr. 2003;22:415–421. doi: 10.1016/S0261-5614(03)00098-0.
    1. Veeramootoo D, Parameswaran R, Krishnadas R, Froeschle P, Cooper M, Berrisford RG, Wajed S. Classification and early recognition of gastric conduit failure after minimally invasive esophagectomy. Surg Endosc. 2009;23:2110–2116. doi: 10.1007/s00464-008-0233-1.
    1. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JCJM, Kaasa S, Klee M, Osoba D, Razavi D, Rofe PB, Schraub S, Sneeuw K, Sullivan M. Takeda F for the European Organization for Research and Treatment of cancer study group on quality of life: the European Organization for Research and Treatment of cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365–376. doi: 10.1093/jnci/85.5.365.
    1. Schulz U, Schwarzer R. Social support in coping with illness: the berlin social support scales (BSSS) Diagnostica. 2003;49:73–82. doi: 10.1026//0012-1924.49.2.73.
    1. Adamsen L, Quist M, Midtgaard J, Andersen C, Møller T, Knutsen L, Tveterås A, Rorth M. The effect of a multidimensional exercise intervention on physical capacity, well-being and quality of life in cancer patients undergoing chemotherapy. Support Care Cancer. 2006;14:116–127. doi: 10.1007/s00520-005-0864-x.
    1. Brdareski Z, Djurović A, Šušnjar S, Životić-Vanović M, Ristić A, Konstantinović L, Vučković-Dekić L, Tankosić M. Effects of a short-term differently dosed aerobic exercise on maximum aerobic capacity in breast cancer survivors: a pilot study. Vojnosanit Pregl. 2012;69(3):237–242. doi: 10.2298/VSP101117004B.
    1. Burnham TR. Wilcox a: effects of exercise on physiological and psychological variables in cancer survivors. Med Sci Sports Exerc. 1863-1867;2002
    1. De Backer IC, Van Breda E, Vreugdenhil A, Nijziel MR, Kester AD, Schep G. High-intensity strength training improves quality of life in cancer survivors. Acta Oncol. 2007;46:1143–1151. doi: 10.1080/02841860701418838.
    1. Tabata I, Kouji N, Motoki K, Yuusuke H, Futoshi O, Motohiko M, Kaoru Y. Effects of moderate-intensity endurance and high-intensity intermittent training on anaerobic capacity and VO2max. Med Sci Sports Exerc. 1996;28:1327–1330. doi: 10.1097/00005768-199610000-00018.
    1. Thorsen L, Skovlund E, Strømme SB, Hornslien K, Dahl AA, Fossa SD. Effectiveness of physical activity on cardiorespiratory fitness and health-related quality of life in young and middle-aged cancer patients shortly after chemotherapy. J Clin Oncol. 2005;10:2378–2388. doi: 10.1200/JCO.2005.04.106.
    1. Trappe HJ, Löllgen H: Guidelines for ergometry. German Society of Cardiology – heart and cardiovascular research. Z Kardiol 2000, 89:821–837.
    1. Borg G. Psycholphysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14:377–381.
    1. Schmitz KH, Courneya KS, Matthews C, Denmark-Wahnefried W, Galvão DA, Pinto BM, et al. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010:1409–26.
    1. Kinugasa S, Tachibana M, Yoshimura H, Ueda S, Fujii T, Dhar DK, Nakamoto T, Nagasue N. Postoperative pulmonary complications are associated with worse short- and long-term outcomes after extended esophagectomy. J Surg Oncol. 2004;88:71–77. doi: 10.1002/jso.20137.
    1. Kumagai K, Rouvelas I, Tsai JA, Mariosa D, Klevebro F, Lindblad M, Ye W, Lundell L, Nilsson M. Meta-analysis of postoperative morbidity and perioperative mortality in patients receiving neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal and gastro-oesophageal junction cancers. Br J Surg. 2014;101:321–338. doi: 10.1002/bjs.9418.
    1. Rock CL, Doyle C, Demark-Wahnefried W, Meyerhardt J, Courneya KS, Schwartz AL, Bandera EV, Hamilton KK, Grant B, McCullough M, Byers T, Gansler T. Nutrition and physical activity guidelines for cancer survivors. CA Cancer J Clin. 2012;62:242–274. doi: 10.3322/caac.21142.
    1. Fletcher GF, Balady GJ, Amsterdam EA, Chaitman B, Eckel R, Fleg J, Froelicher VF, Leon AS, Piña IL, Rodney R, Simons-Morton DA, Williams MA, Bazzarre T. Exercise standards for testing and training: a statement for healthcare professionals from the American Heart Association. Circulation. 2001;104:1694–1740. doi: 10.1161/hc3901.095960.
    1. HUDSON RCI Voldyne® 5000 Incentive Spirometer, Item Code 8884719009.
    1. Folstein MF, Folstein SE, McHugh PR: “Mini-mental state”. A practical method for grading the cognitive state of patients for the clinician. J Psychiat Res 1975, 12:189–198.
    1. Watson YI, Arfken CL, Birge SJ. Clock completion: an objective screening test for dementia. J Am Geriatr Soc. 1993;41:1235–1240. doi: 10.1111/j.1532-5415.1993.tb07308.x.

Source: PubMed

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