CYCLE pilot: a protocol for a pilot randomised study of early cycle ergometry versus routine physiotherapy in mechanically ventilated patients

Michelle E Kho, Alexander J Molloy, France Clarke, Margaret S Herridge, Karen K Y Koo, Jill Rudkowski, Andrew J E Seely, Joseph R Pellizzari, Jean-Eric Tarride, Marina Mourtzakis, Timothy Karachi, Deborah J Cook, Canadian Critical Care Trials Group, Daana Ajami, Laura Camposilvan, Magda McCaughan, Christina Murphy, Kristy Obrovac, Wendy Perry, Diana Hatzoglou, Miranda Prince, Bashir Versi, France Clarke, F Aileen Costigan, Marnie Jakab, Michael Ciancone, Devin McCaskell, Janelle Unger, Julie Reid, Thomas Piraino, Bram Rochwerg, Tania Brittain, Shivaun Davidson, Christopher Farley, Andrea Galli, Leigh Ann Niven, Jessica Temesy, Helen Bishop, Shannon Earl, Chelsea Hale, Gillian Manson, Tina Millen, Alison Fox-Robichaud, Ashley Eves, Elise Loreto, Anastasia Newman, Judi Rajczak, Julie Reid, Sarah Lohanyai, Jennifer Duley, Sue Mahler, Matthew McCaffrey, Jessica Pilon-Bignell, Ellen McDonald, Julie Reid, Vincent Lo, Sunita Mathur, Anne-Marie Bourgeois, Nathalie Côté, Adriane Lachmaniuk, Vincent Lo, Sophie Mendo, Gary Beauchamp, Sherry Harburn, Megan Hudson, Teresa Torres, Andrea Matte, Jaimie Archer, Daniel Chen, Luciana Urache, Ian Ball, Kristen Abercombie, Erin Blackwell-Knowles, Jennifer Curry, Tania Larsen, Jennifer Jackson, Eileen Campbell, Rebecca Rondinelli St Michael, Karen Burns, Jan Friedrich, Sarah Brown, Deanna Feltracco, Christine Leger, Diana Horobetz, Anna Michalski, Verity Tulloch, Natalia Zapata, Orla Smith, Kurtis Salway, Rachel Goard, Josée Lamontagne, Michelle Cummings, Sarah Patten, Irene Watpool, Rebecca Porteous, Brigette Gomes, Shelley Acres, Heather Langlois, Michelle E Kho, Alexander J Molloy, France Clarke, Margaret S Herridge, Karen K Y Koo, Jill Rudkowski, Andrew J E Seely, Joseph R Pellizzari, Jean-Eric Tarride, Marina Mourtzakis, Timothy Karachi, Deborah J Cook, Canadian Critical Care Trials Group, Daana Ajami, Laura Camposilvan, Magda McCaughan, Christina Murphy, Kristy Obrovac, Wendy Perry, Diana Hatzoglou, Miranda Prince, Bashir Versi, France Clarke, F Aileen Costigan, Marnie Jakab, Michael Ciancone, Devin McCaskell, Janelle Unger, Julie Reid, Thomas Piraino, Bram Rochwerg, Tania Brittain, Shivaun Davidson, Christopher Farley, Andrea Galli, Leigh Ann Niven, Jessica Temesy, Helen Bishop, Shannon Earl, Chelsea Hale, Gillian Manson, Tina Millen, Alison Fox-Robichaud, Ashley Eves, Elise Loreto, Anastasia Newman, Judi Rajczak, Julie Reid, Sarah Lohanyai, Jennifer Duley, Sue Mahler, Matthew McCaffrey, Jessica Pilon-Bignell, Ellen McDonald, Julie Reid, Vincent Lo, Sunita Mathur, Anne-Marie Bourgeois, Nathalie Côté, Adriane Lachmaniuk, Vincent Lo, Sophie Mendo, Gary Beauchamp, Sherry Harburn, Megan Hudson, Teresa Torres, Andrea Matte, Jaimie Archer, Daniel Chen, Luciana Urache, Ian Ball, Kristen Abercombie, Erin Blackwell-Knowles, Jennifer Curry, Tania Larsen, Jennifer Jackson, Eileen Campbell, Rebecca Rondinelli St Michael, Karen Burns, Jan Friedrich, Sarah Brown, Deanna Feltracco, Christine Leger, Diana Horobetz, Anna Michalski, Verity Tulloch, Natalia Zapata, Orla Smith, Kurtis Salway, Rachel Goard, Josée Lamontagne, Michelle Cummings, Sarah Patten, Irene Watpool, Rebecca Porteous, Brigette Gomes, Shelley Acres, Heather Langlois

Abstract

Introduction: Early exercise with in-bed cycling as part of an intensive care unit (ICU) rehabilitation programme has the potential to improve physical and functional outcomes following critical illness. The objective of this study is to determine the feasibility of enrolling adults in a multicentre pilot randomised clinical trial (RCT) of early in-bed cycling versus routine physiotherapy to inform a larger RCT.

Methods and analysis: 60-patient parallel group pilot RCT in 7 Canadian medical-surgical ICUs. We will include all previously ambulatory adult patients within the first 0-4 days of mechanical ventilation, without exclusion criteria. After informed consent, patients will be randomised using a web-based, centralised electronic system, to 30 min of in-bed leg cycling in addition to routine physiotherapy, 5 days per week, for the duration of their ICU stay (28 days maximum) or routine physiotherapy alone. We will measure patients' muscle strength (Medical Research Council Sum Score, quadriceps force) and function (Physical Function in ICU Test (scored), 30 s sit-to-stand, 2 min walk test) at ICU awakening, ICU discharge and hospital discharge. Our 4 feasibility outcomes are: (1) patient accrual of 1-2 patients per month per centre, (2) protocol violation rate <20%, (3) outcome measure ascertainment >80% at the 3 time points and (4) blinded outcomes ascertainment >80% at hospital discharge. Hospital outcome assessors are blinded to group assignment, whereas participants, ICU physiotherapists, ICU caregivers, research coordinators and ICU outcome assessors are not blinded to group assignment. We will analyse feasibility outcomes with descriptive statistics.

Ethics and dissemination: Each participating centre will obtain local ethics approval, and results of the study will be published to inform the design and conduct of a future multicentre RCT of in-bed cycling to improve physical outcomes in ICU survivors.

Trial registration number: NCT02377830; Pre-results.

Keywords: STATISTICS & RESEARCH METHODS.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Figures

Figure 1
Figure 1
Planned flow of participants throughout the CYCLE pilot RCT. ADL, activities of daily living; ICU, intensive care unit; MV, mechanically ventilated; PT, physiotherapy; RCT, randomised clinical trial.

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