1. STRIVE pilot trial: a protocol for a multicentre pragmatic internal pilot randomised controlled trial of Structured TRaining to Improve fitness in a Virtual Environment (STRIVE) before surgery
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Alan Forster, Nicola Edwards, Jean Wong, Frances Chung, Luke T Lavallée, François Lellouche, Monica Taljaard, Tim Ramsay, James Paul, Michael Schmidt, Manoj M Lalu, Jason Chui, Stephen Choi, Shelly Au, Richard Hall, Harsha Shanthanna, Hance Clarke, Stuart Mccluskey, Marcin Wasowicz, Karim Ladha, Angela Jerath, Daniel Sellers, Thomas Schricker, Roupen Hatzakorzian, Stephen Kowalski, James Green, Daniel I McIsaac, Guillaume Martel, Merrick Zwarenstein, Sylvain Boet, Kednapa Thavorn, I Singh, Karim Abdulla, Margaret L McNeely, Jessica Spence, Emilie Belley-Cote, Julie Hallet, Herman Sehmbi, Tarit Saha, David Rosen, George Wang, Connor Brenna, Tien Le, Ruth Graham, Husein Moloo, Hilary Grocott, Kelly Vogt, Gary Dobson, Faisal Siddiqui, Alexis Turgeon, Frédérick D’Aragon, Martin Girard, Brian Cuthbertson, Timothy Jackson, Ian Gilron, Norman Buckley, Andy Liu, Naveed Siddiqui, Leyla Baghirzada, Stephen Yang, William Wang, James Kim, Neil Goldenberg, Nicolas Beaudet, Dean Fergusson, Keyvan Karkouti, Jordan Tarshis, Colin McCartney, Vishal Uppal, Christopher Prabhakar, Derek Dillane, Jordan Leitch, Ramiro Arellano, Joel Parlow, George Djaiani, Lilia Kaustov, Peter Hedlin, Andrew Milne, Heather McDonald, David Boyle, Isabelle Raiche, Lara Williams, Emily Hladkowicz, Sylvain Gagne, Celena Scheede-Bergdahl, C David Mazer, Justyna Bartoszko, Chelsia Gillis, Michael Law, Edmond Li, Sarah Sinasac, Roberta DiDonato, Rene Martin, Thomas Hemmerling, Beverley Orser, Pierre Drolet, Vatsal Trivedi, Jason McVicar, Daniel Bainbridge, Pierre Beaulieu, Faraj Abdallah, Naheed Jivraj, Heather Pierce, Hema Bagry, Rakesh Sondekoppam, Christian Lehmann, John Fuller, Derek Roberts, Homer Yang, Stuart Wright, Michael Jacka, Curtis Nickel, Rodney Breau, Daenis Camire, Nidhi Charan, Louise Sun, Susan Lee, Rachel Khadaroo, Amanda Meliambro, Jennifer O’Brien, Renée El-Gabalawy, Daniel Trottier, Keely Barnes, Laura Boland, Karina Branje, Rosaleen Chun, Antoine Eskander, Joanne Hutton, John Joanisse, Cameron Love, Thomas Mutter, Sudhir Nagpal, Pablo Serrano, Carl van Walraven, Ilun Yang, Bryan Glezerson, Sylvie Aucoin, Rebecca Auer, Gregory Bryson, Dolores McKeen, Tyrone Harrison, Puneeta Tandon, Michael Verret, Sarah McMullen, William Beaubien-Souligny, Duminda Nalaka Wijeysundera, Samantha Russell, Victor Neira, Matthias Görges, Catherine Duclos, Etienne Couture, Diem Tran, Stephan Schwarz, Alana Flexman, Terri Sun, Michelle Mozel, Olivier Royer, Gurlavine Kidd, Tyler Chesney, Humberto R Vigil, Mary Farnand, Juliette Gaudreault, Bhagya Lakshmi Ramappa Tahasildar, Julian Mansour, William Scott Beattie, André Denault, Kathryn Sparrow, Jamal Alkadri, Saleh Al-Nahdi, Siniana Avramescu, Jonathan Bailey, Alex Bak, Gabriele Baldinii, Jean-Marie Bamvita, Jillian Banfield, Michael Bautista, Jean Beaubien, Gianluca Bertolizio, Guillaume Bousquet-Dion, Scott Brudney, Neville Burke, Jean Bussières, Matthew Cameron, Francois M Carrier, Françoise Chagnon, Anton Chau, Marshall Cheng, Gilles Chiniara, Janice Chisholm, Michelle Chiu, Chris Christodoulou, Pieter de Jager, Megan Deck, Ainsley Decker, Alain Deschamps, Daniel Dubois, Laura Duggan, Tristan Dumbarton, Deborah DuMerton Shore, Kaylene Duttchen, Darcie Earle, Marie-Pierre Gagne, Nicole Gibson, Andres-Felipe Gil, Talha Gondal, Daniel Gottesman, Alexander Gregory, Alexander Grunfeld, Gregory Hare, Jennifer Héroux, Orlando Hung, Janny Ke, Brent Kennedy, Brad Kerr, Margot Klemmer, Wing Lam, Danielle Lapierre, Jean-Sebastian Lebon, Vincent Lecluyse, Alexandre Lefebvre, Nagappa Mahes, William McKay, Perseus Missirlis, Glenio Mizubuti, Peter Moliner, Corentin Monfort, Janice Montbriand, Maliha Muneer, Allana Munro, Bhanu Nalla, Wayne Nates, David Neilpovitz, Angela Neufeld, Angélica Ostiguy, Charles Overbeek, Jean P Gelinas, Gilles Plourde, Jeremy Pridham, Mateen Raazi, Saifee Rashiq, Ravi Jayas, Ravi Taneja, Rebecca Grey, Tracey Rice, Richard N Merchant, David Roach, Roanne Preston, Ron Ree, Ronald George, Jean-Dennis Roy, Rudy Noppens, Ryan McGinn, Ryan Ramos, Sonia Sampson, Corey Sawchuk, Seyed Mahdi Sedighi, Surita Sidhu, Stephanie Sobotie, Sabri Soussi, Summer Sukh Brar, Varun Suresh, Vanessa Sweet, Linda Szabo, Edmond Tan, Mullein Thorleifson, Andrea Todd, Victor Tran, Dianshi Wang, Louie Wang, Geoff Warden, Kim Wong, Vincent Wourms, Cynthia Yarnold, and Doreen Yee
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Medicine - Abstract
Introduction Home-based, virtually-supported care models may represent the most efficient and scalable approach to delivering prehabilitation services. However, virtual approaches to prehabilitation are understudied. This manuscript describes the protocol for an internal pilot randomised controlled trial of a virtually-delivered, multimodal prehabilitation intervention.Methods and analysis We will conduct a pragmatic, individual patient, internal pilot randomised controlled trial of home-based, virtually supported, multimodal prehabilitation compared with standard perioperative care in adults undergoing elective, inpatient thoracic, abdominal, pelvic and vascular surgery at five Canadian hospitals. Participants will be partially blinded; clinicians and outcome assessors will be fully blinded. The intervention consists of 3–12 weeks of a home-based, multimodal (exercise, nutrition and psychosocial support) prehabilitation programme supported through an online platform. The primary feasibility outcomes and their progression targets are (1) monthly recruitment of>6 participants at each centre, (2) intervention adherence of>75%, (3) retention of>90% of participants at the patient-reported primary outcome point of 30-days after surgery and (4) elicitation of patient, clinician and researcher-identified barriers to our pragmatic trial. A sample size of 144 participants will be adequate to estimate recruitment, adherence and retention rates with acceptable precision. All participants will be followed to either death or up to 1 year. As an internal pilot, if no substantive changes to the trial or intervention design are required, pilot participant outcome data will migrate, unanalysed by allocation, to the future full-scale trial.Ethics and dissemination Ethical approval has been granted by Clinical Trials Ontario (Project ID: 4479) and our ethics review board (Protocol Approval #20230399–01T). Results will be disseminated through presentations at scientific conferences, peer-reviewed publications, partner organisations and engagement of social and traditional media.Trial registration number ClinicalTrials.gov identifier NCT06042491. Protocol, V.1.2, dated 6 June 2024.
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- 2024
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