Critical Care Cycling to Improve Lower Extremity Strength (CYCLE): protocol for an international, multicentre randomised clinical trial of early in-bed cycling for mechanically ventilated patients
Avelino C Verceles,
Jennifer L Y Tsang,
Sangeeta Mehta,
Michelle E Kho,
Alexander J Molloy,
Margaret S Herridge,
Bram Rochwerg,
Ian M Ball,
Joseph R Pellizzari,
Jean-Eric Tarride,
Diane Heels-Ansdell,
John Muscedere,
Francois Lamontagne,
Tim Karachi,
Alison Fox-Robichaud,
Shane W English,
Karen E A Burns,
Frédérick D'Aragon,
Sue Berney,
Karim Serri,
Erick H Duan,
Lisa Buckingham,
Julie Reid,
Andrew J Seely,
Christopher Farley,
Amy M Pastva,
Heather O'Grady,
Laurel Kelly,
Geoff Strong,
Abby H Hurd
Affiliations
Avelino C Verceles
31 Department of Medicine, University of Maryland Medical Center, Baltimore, Maryland, USA
Jennifer L Y Tsang
1 Niagara Health, St Catharines, Ontario, Canada
Sangeeta Mehta
Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada
Michelle E Kho
1 School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada
Alexander J Molloy
2 Physiotherapy Department, St. Joseph’s Healthcare Hamilton, Hamilton, Ontario, Canada
Margaret S Herridge
professor
Bram Rochwerg
1 Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada
Ian M Ball
12 Department of Medicine, Western University, London, Ontario, Canada
1 Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada
Diane Heels-Ansdell
statistician
John Muscedere
Critical Care, Kingston General Hospital, Kingston, Ontario, Canada
Francois Lamontagne
9 University of Sherbrooke, Sherbrooke, QC, Canada
Tim Karachi
1 Department of Medicine, Critical Care, McMaster University, Hamilton, Ontario, Canada
Introduction In-bed leg cycling with critically ill patients is a promising intervention aimed at minimising immobility, thus improving physical function following intensive care unit (ICU) discharge. We previously completed a pilot randomised controlled trial (RCT) which supported the feasibility of a large RCT. In this report, we describe the protocol for an international, multicentre RCT to determine the effectiveness of early in-bed cycling versus routine physiotherapy (PT) in critically ill, mechanically ventilated adults.Methods and analysis We report a parallel group RCT of 360 patients in 17 medical-surgical ICUs and three countries. We include adults (≥18 years old), who could ambulate independently before their critical illness (with or without a gait aid), ≤4 days of invasive mechanical ventilation and ≤7 days ICU length of stay, and an expected additional 2-day ICU stay, and who do not fulfil any of the exclusion criteria. After obtaining informed consent, patients are randomised using a web-based, centralised system to either 30 min of in-bed cycling in addition to routine PT, 5 days per week, up to 28 days maximum, or routine PT alone. The primary outcome is the Physical Function ICU Test-scored (PFIT-s) at 3 days post-ICU discharge measured by assessors blinded to treatment allocation. Participants, ICU clinicians and research coordinators are not blinded to group assignment. Our sample size estimate was based on the identification of a 1-point mean difference in PFIT-s between groups.Ethics and dissemination Critical Care Cycling to improve Lower Extremity (CYCLE) is approved by the Research Ethics Boards of all participating centres and Clinical Trials Ontario (Project 1345). We will disseminate trial results through publications and conference presentations.Trial registration number NCT03471247 (Full RCT); NCT02377830 (CYCLE Vanguard 46 patient internal pilot).
