Blood Flow Restriction Exercise in the Perioperative Setting to Prevent Loss of Muscle Mass in Patients with Pancreatic, Biliary Tract, and Liver Cancer: Study protocol for the PREV-Ex Randomized Controlled Trial

Blood Flow Restriction Exercise in the Perioperative Setting to Prevent Loss of Muscle Mass in Patients with Pancreatic, Biliary Tract, and Liver Cancer: Study protocol for the PREV-Ex Randomized Controlled Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Blood Flow Restriction Exercise in the Perioperative Setting to Prevent Loss of Muscle Mass in Patients with Pancreatic, Biliary Tract, and Liver Cancer: Study protocol for the PREV-Ex Randomized Controlled Trial Poorna Anandavadivelan, Daniele Cardinale, Rune Blomhoff, Berit Sunde, and 6 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4083576/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 4 You are reading this latest preprint version Abstract Background : Patients diagnosed with pancreatic, biliary tract, and liver cancer often suffer from a progressive loss of muscle mass. Given the considerable functional impairments in these patients, high musculoskeletal weight loads may not be well tolerated by all individuals. The use of blood-flow restricted resistance training (BFR-T) which only requires low training loads may allow for a faster recovery of muscle due to avoidance of high levels of mechanical muscle stress associated with high-load resistance exercise. This study aims to investigate whether BFR-T can prevent or slow down the loss of skeletal muscle mass and enhance functional capacity and mental health of patients with pancreatic, biliary tract, and liver cancer. Methods : The PREV-Ex exercise trial is a multicentre two-armed randomized-controlled trial. Patients will be randomized to an exercise program consisting of home-based low-load BFR-T during a pre- and postoperative period for a total of 6-10 weeks, or to a control group. Protein supplementation will be given to both groups to ensure adequate protein intake. The primary outcome, skeletal muscle thickness and muscle cross-sectional area will be assessed by ultrasound. Secondary outcomes include: i) muscle catabolism related and inflammatory bio-markers (molecular characteristics will be assessed from a vastus lateralis biopsy and blood samples will be obtained from a sub-sample of patients); ii) Patient-reported outcome measures (self-reported fatigue, health-related quality of life, and nutritional status will be assessed through validated questionnaires); iii) Physical fitness/performance/activity (validated tests will be used to evaluate physical function, cardiorespiratory fitness and maximal isometric muscle strength. Physical activity and sedentary behaviour (assessed using an activity monitor); iv) Clinical outcomes: hospitalization rates and blood status will be recorded from the patients’ medical records; v) Explorative outcomes of patients’ experience of the exercise program will be evaluated using focus group/individual interviews. Discussion : It is worthwhile to investigate new strategies that have potential to counteract the deterioration of skeletal muscle mass, muscle function, strength, and physical function, all of which have debilitating consequences for patients with pancreatic, biliary tract, and liver cancer. The expected findings could improve prognosis, help patients stay independent for longer, and possibly reduce treatment related costs. Trial registration: Clinicaltrials.gov, NCT05044065, date of registration: September 14th 2021, https://clinicaltrials.gov/study/NCT05044065 Blood flow restriction training Pancreatic cancer Biliary tract cancer Liver cancer Prehabilitation Rehabilitation Skeletal muscle mass Muscle atrophy Full Text Cite Share Download PDF Status: Under Review Version 1 posted Reviewers agreed at journal 15 May, 2024 Reviewers invited by journal 15 May, 2024 Editor assigned by journal 15 Mar, 2024 First submitted to journal 12 Mar, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4083576","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":302831916,"identity":"2eb1f01f-de82-4028-8d30-24c761d59b4d","order_by":0,"name":"Poorna Anandavadivelan","email":"","orcid":"","institution":"Karolinska Institutet","correspondingAuthor":false,"prefix":"","firstName":"Poorna","middleName":"","lastName":"Anandavadivelan","suffix":""},{"id":302831917,"identity":"314e0c50-6d6a-47c0-b8e3-fcf74995d10e","order_by":1,"name":"Daniele Cardinale","email":"","orcid":"","institution":"Karolinska 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