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Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients
  1. Michelle E Kho1,2,
  2. Alexander J Molloy2,
  3. France J Clarke3,
  4. Julie C Reid1,
  5. Margaret S Herridge4,
  6. Timothy Karachi5,
  7. Bram Rochwerg3,5,
  8. Alison E Fox-Robichaud6,
  9. Andrew JE Seely7,
  10. Sunita Mathur8,9,
  11. Vincent Lo10,
  12. Karen EA Burns11,
  13. Ian M Ball12,13,
  14. Joseph R Pellizzari14,15,
  15. Jean-Eric Tarride3,
  16. Jill C Rudkowski5,
  17. Karen Koo16,17,
  18. Diane Heels-Ansdell3 and
  19. Deborah J Cook3,5
  20. Canadian Critical Care Trials Group
  1. 1 School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada
  2. 2 Physiotherapy Department, St. Joseph’s Healthcare Hamilton, Hamilton, Ontario, Canada
  3. 3 Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
  4. 4 Toronto General Research Institute, University Health Network, Toronto, Ontario, Canada
  5. 5 Department of Medicine, McMaster University, Hamilton, Ontario, Canada
  6. 6 Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada
  7. 7 Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada
  8. 8 Department of Physical Therapy, University of Toronto, Toronto, Ontario, Canada
  9. 9 Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada
  10. 10 Department of Physical Therapy, Toronto General Hospital, Toronto, Ontario, Canada
  11. 11 Interdepartmental Division of Critical Care and the Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada
  12. 12 Department of Medicine, Western University, London, Ontario, Canada
  13. 13 Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada
  14. 14 Consultation-Liaison Psychiatry Service, St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada
  15. 15 Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada
  16. 16 Swedish Medical Group, Seattle, Washington, USA
  17. 17 Department of Medicine, Western University, London, ON, Canada
  1. Correspondence to Dr Michelle E Kho; khome{at}mcmaster.ca

Abstract

Introduction Acute rehabilitation in critically ill patients can improve post-intensive care unit (post-ICU) physical function. In-bed cycling early in a patient’s ICU stay is a promising intervention. The objective of this study was to determine the feasibility of recruitment, intervention delivery and retention in a multi centre randomised clinical trial (RCT) of early in-bed cycling with mechanically ventilated (MV) patients.

Methods We conducted a pilot RCT conducted in seven Canadian medical-surgical ICUs. We enrolled adults who could ambulate independently before ICU admission, within the first 4 days of invasive MV and first 7 days of ICU admission. Following informed consent, patients underwent concealed randomisation to either 30 min/day of in-bed cycling and routine physiotherapy (Cycling) or routine physiotherapy alone (Routine) for 5 days/week, until ICU discharge. Our feasibility outcome targets included: accrual of 1–2 patients/month/site; >80% cycling protocol delivery; >80% outcomes measured and >80% blinded outcome measures at hospital discharge. We report ascertainment rates for our primary outcome for the main trial (Physical Function ICU Test-scored (PFIT-s) at hospital discharge).

Results Between 3/2015 and 6/2016, we randomised 66 patients (36 Cycling, 30 Routine). Our consent rate was 84.6 % (66/78). Patient accrual was (mean (SD)) 1.1 (0.3) patients/month/site. Cycling occurred in 79.3% (146/184) of eligible sessions, with a median (IQR) session duration of 30.5 (30.0, 30.7) min. We recorded 43 (97.7%) PFIT-s scores at hospital discharge and 37 (86.0%) of these assessments were blinded.

Discussion Our pilot RCT suggests that a future multicentre RCT of early in-bed cycling for MV patients in the ICU is feasible.

Trial registration number NCT02377830.

  • exercise therapy
  • critical illness/*rehabilitation
  • *respiration, artificial/adverseeffects/ methods
  • bed rest/ adverse effects
  • critical care

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Collaborators We are grateful to the following participating sites, Site Principal Investigators (PI), Additional Co-Investigators, Physiotherapists (ICU PTs, blinded assessors), research coordinators (RC), research assistants (RA), and students who contributed to the CYCLE Pilot RCT: St. Joseph’s Healthcare: Site PI: Michelle Kho, Intensivists: Deborah Cook, Jill Rudkowski, ICU PTs: Daana Ajami, Laura Camposilvan (PT Assistant), Michelle Kho, Magda McCaughan, Christina Murphy, Kristy Obrovac; Blinded assessors: Diana Hatzoglou, Wendy Perry, Miranda Prince (PT Assistant), Bashir Versi; RCs: Alexander Molloy, France Clark, F Aileen Costigan, Marnie Jakab, Laura Childerhose; RAs: Michael Ciancone, Ravish Gupta, Devin McCaskell, Amy Seczek; PT Students: Janelle Unger, Catherine Hare; Graduate Student, Julie Reid; Clinical Psychologist: Joseph Pellizzari; Co-Investigator: Thomas Piraino. Juravinksi Hospital: Site PIs: Timothy Karachi, Bram Rochwerg; ICU PTs: Tania Brittain, Shivaun Davidson, Christopher Farley, Andrea Galli, Leigh Ann Niven, Jessica Temesy; Blinded assessors: Helen Bishop, Shannon Earl (PT Assistant), Chelsea Hale, Gillian Manson; RC: Tina Millen; Hamilton General Hospital: Site PI: Alison Fox-Robichaud; ICU PTs: Ashley Eves, Elise Loreto, Anastasia Newman, Judi Rajczak, Julie Reid, Sarah Lohanyai; Blinded Assessors: Jennifer Duley, Sue Mahler, Matthew McCaffrey, Jessica Pilon-Bignell; RC: Ellen McDonald; RA: Julie Reid; Toronto General Hospital: Site PIs: Vincent Lo, Sunita Mathur; Intensivist: Margaret Herridge; ICU PTs: Anne-Marie Bourgeois, Nathalie Côté, Adriane Lachmaniuk, Vincent Lo, Sophie Mendo; Blinded Assessors: Gary Beauchamp, Sherry Harburn, Megan Hudson, Teresa Torres; RC: Andrea Matte; RAs: Jaimie Archer, Daniel Chen, Luciana Urache; London Health Sciences: Site PI: Ian Ball; ICU PTs: Kristen Abercombie, Erin Blackwell-Knowles, Jennifer Curry, Tania Larsen; Blinded Assessor: Jennifer Jackson; RC: Eileen Campbell; RA: Rebecca Rondinelli St. Michael’s Hospital: Site PIs: Karen Burns, Jan Friedrich; ICU PTs: Sarah Brown, Deanna Feltracco, Christine Leger; Blinded Assessors: Diana Horobetz, Anna Michalski, Verity Tulloch, Natalia Zapata; RCs: Orla Smith, Kurtis Salway, Gyan Sandhu; Ottawa General Hospital: Site PI: Andrew Seely; ICU PTs: Rachel Goard, Josée Lamontagne; Blinded Assessors: Michelle Cummings, Sarah Patten; RCs: Irene Watpool, Rebecca Porteous, Brigette Gomes; RAs: Shelley Acres, Heather Langlois. Additional co-investigator: Marina Mourtzakis, University of Waterloo.

  • Contributors Substantial contributions to conception or design: MEK, AJM, FJC, MH, TK, AS, AEF-R, J-ET, DC. Acquisition, analysis or interpretation of the data: MEK, AJM, FJC, JCR, MH, BR, TK, VL, AEF-R, AS, KB, IMB, JRP, J-ET, DH-A. Drafting the work: MEK, DC. Critical revisions for important intellectual content: all authors. Final approval of the version submitted for publication: all authors. Accountability for all aspects of the work: MEK.

  • Funding This work was supported by grants from Technology Evaluation in the Elderly Network Catalyst (now Canadian Frailty Network; CAT2014-05), Canadian Respiratory Research Network Emerging Research Leaders Initiative, Ontario Thoracic Society Grant-in-Aid and Canadian Institutes of Health Research Transitional Operating Grant (Award #142327), Canada Foundation for Innovation, and the Ontario Ministry of Research and Innovation. MEK and DC are each funded by a Canada Research Chair. Restorative Therapies (Baltimore, MD) provided 2 RT-300 supine cycle ergometers for Toronto General Hospital and London Health Sciences sites for this research.

  • Disclaimer The funding sources and equipment manufacturer had no role in the design, execution, analysis or interpretation of this study or decision to submit results.

  • Competing interests Restorative Therapies (Baltimore, MD) provided 2 RT-300 supine cycle ergometers for Toronto General Hospital and London Health Sciences sites for this research.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement No additional data are available.