International Journal of Clinical Trials | April-June 2020 | Vol 7 | Issue 2 Page 103 International Journal of Clinical Trials Berkel AEM et al. Int J Clin Trials. 2020 May;7(2):103-111 http://www.ijclinicaltrials.com pISSN 2349-3240 | eISSN 2349-3259 Protocol Study protocol of a single-arm pre-post study to assess the preliminary effectiveness and feasibility of a home-based bimodal prehabilitation program on preoperative aerobic fitness in high-risk patients scheduled for liver or pancreatic resection Annefleur E. M. Berkel 1 , Laura Van Wijk 2 , Bart C. Bongers 3,4 , Job Van Der Palen 5 , Carlijn I. Buis 2 , Muriel Reudink 6 , Mike S. L. Liem 1 , Gerrit D. Slooter 6 , Nico L. U. Van Meeteren 4,7 , Joost M. Klaase 2 * ABSTRACT Background: Controversial evidence currently exists regarding the feasibility and effectiveness to improve preoperative aerobic fitness during home-based prehabilitation in patients scheduled for liver or pancreatic resection, whereas morbidity rates are high following these resections. The primary aim of this study is to evaluate the preoperative oxygen uptake (VO 2 ) at the ventilatory anaerobic threshold before and after a four-week home-based preoperative training program with nutritional supplementation in high-risk patients scheduled for elective liver or pancreatic resection. Secondary aims are to evaluate program feasibility, immune system function, cardiopulmonary exercise test responses, individual progression profiles on training responses, quality of life, and postoperative course. Methods: In this multicenter study with a pretest-posttest design, patients with a liver or pancreatic tumor scheduled for elective resection will be recruited. To select the high-risk fraction of this surgical population, their VO 2 at the ventilatory anaerobic threshold should be <11 ml/kg/min for final inclusion. A planned total of 24 high-risk patients will participate in a four-week (three sessions per week) home-based bimodal prehabilitation program. The partly supervised home-based preoperative training program consists of individualized goal setting followed by titration of interval and endurance training on an advanced cycle ergometer, combined with functional task exercises. Additionally, patients will be given protein and vitamin/mineral supplementation. Discussion: Effects of a partly supervised home-based bimodal prehabilitation regimen are unknown in high-risk patients opting for liver or pancreatic resection. Improved preoperative aerobic fitness might translate into improved postoperative outcomes and a reduced demand on care resources. Trial Registration: The study is registered in the Netherlands Trial Registry (NL6151) and was approved by the Institutional Ethics Committee, Twente, Enschede, the Netherlands (P17-08). Keywords: Aerobic fitness, Cardiopulmonary exercise testing, Cardiorespiratory fitness, Hepatopancreatobiliary surgery, Home-based training, Prehabilitation 1 Department of Surgery, Medisch Spectrum Twente, Enschede, The Netherlands 2 Department of Surgery, University Medical Center Groningen, Groningen, Groningen, The Netherlands 3 Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands 4 Department of Epidemiology, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands 5 Department of Epidemiology, Medisch Spectrum Twente, Enschede, The Netherlands 6 Department of Surgery, Maxima Medical Center, Veldhoven, The Netherlands 7 Top Sector Life Sciences and Health (Health~Holland), The Hague, The Netherlands Received: 13 January 2020 Revised: 17 March 2020 Accepted: 19 March 2020 *Correspondence: Dr. Joost M. Klaase, E-mail: j.m.klaase@umcg.nl Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. DOI: http://dx.doi.org/10.18203/2349-3259.ijct20201716