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

Simple item page
dc.contributor.authorAnnefleur, E. M. Berkelen_US
dc.contributor.authorLaura, Van Wijken_US
dc.contributor.authorBart, C. Bongersen_US
dc.contributor.authorJob, Van Der Palenen_US
dc.contributor.authorCarlijn, I. Buisen_US
dc.contributor.authorMuriel, Reudinken_US
dc.contributor.authorMike, S. L. Liemen_US
dc.contributor.authorGerrit, D. Slooteren_US
dc.contributor.authorNico, L. U. Van Meeterenen_US
dc.contributor.authorJoost, M. Klaaseen_US
dc.date.accessioned2020-05-06T08:34:22Z
dc.date.available2020-05-06T08:34:22Z
dc.date.issued2020-04
dc.description.abstractBackground: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 (VO2) at the ventilatory anaerobic threshold before and after a four-week home-based preoperative training program with nutritional supplementation in high-riskpatients 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, andpostoperative 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 VO2at 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)en_US
dc.identifier.affiliationsDepartment of Surgery, Medisch Spectrum Twente, Enschede, The Netherlandsen_US
dc.identifier.affiliationsDepartment of Surgery, University Medical Center Groningen, Groningen, Groningen, The Netherlandsen_US
dc.identifier.affiliationsDepartment of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlandsen_US
dc.identifier.affiliationsDepartment of Epidemiology, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlandsen_US
dc.identifier.affiliationsDepartment of Epidemiology, Medisch Spectrum Twente, Enschede, The Netherlandsen_US
dc.identifier.affiliationsDepartment of Surgery, Maxima Medical Center, Veldhoven, The Netherlandsen_US
dc.identifier.affiliationsTop Sector Life Sciences and Health (Health~Holland), The Hague, The Netherlandsen_US
dc.identifier.citationAnnefleur E. M. Berkel, Laura Van Wijk, Bart C. Bongers, Job Van Der Palen, Carlijn I. Buis, Muriel Reudink, Mike S. L. Liem, Gerrit D. Slooter, Nico L. U. Van Meeteren, Joost M. Klaase. 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. International Journal of Clinical Trials. 2020 Apr; 7(2): 103-111en_US
dc.identifier.issn2349-3240
dc.identifier.issn2349-3259
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/200953
dc.languageenen_US
dc.publisherMedip Academyen_US
dc.relation.issuenumber2en_US
dc.relation.volume7en_US
dc.source.urihttps://dx.doi.org/10.18203/2349-3259.ijct20201716en_US
dc.subjectAerobic fitnessen_US
dc.subjectCardiopulmonary exercise testingen_US
dc.subjectCardiorespiratory fitnessen_US
dc.subjectHepatopancreatobiliary surgeryen_US
dc.subjectHome-based trainingen_US
dc.subjectPrehabilitationen_US
dc.titleStudy 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 resectionen_US
dc.typeJournal Articleen_US
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
ijct2020v7n2p103.pdf
Size:
247.14 KB
Format:
Adobe Portable Document Format
Download
Collections
International Journal of Clinical Trials