C ritical Care C yc ling to Improve L ower E xtremity Strength (CYCLE): protocol for an international, multicentre randomised clinical trial of early in-bed cycling for mechanically ventilated patients

Michelle E Kho, Julie Reid, Alexander J Molloy, Margaret S Herridge, Andrew J Seely, Jill C Rudkowski, Lisa Buckingham, Diane Heels-Ansdell, Tim Karachi, Alison Fox-Robichaud, Ian M Ball, Karen E A Burns, Joseph R Pellizzari, Christopher Farley, Sue Berney, Amy M Pastva, Bram Rochwerg, Frédérick D'Aragon, Francois Lamontagne, Erick H Duan, Jennifer L Y Tsang, Patrick Archambault, Shane W English, John Muscedere, Karim Serri, Jean-Eric Tarride, Sangeeta Mehta, Avelino C Verceles, Brenda Reeve, Heather O'Grady, Laurel Kelly, Geoff Strong, Abby H Hurd, Lehana Thabane, Deborah J Cook, CYCLE Investigators and the Canadian Critical Care Trials Group, Michelle E Kho, Julie Reid, Alexander J Molloy, Margaret S Herridge, Andrew J Seely, Jill C Rudkowski, Lisa Buckingham, Diane Heels-Ansdell, Tim Karachi, Alison Fox-Robichaud, Ian M Ball, Karen E A Burns, Joseph R Pellizzari, Christopher Farley, Sue Berney, Amy M Pastva, Bram Rochwerg, Frédérick D'Aragon, Francois Lamontagne, Erick H Duan, Jennifer L Y Tsang, Patrick Archambault, Shane W English, John Muscedere, Karim Serri, Jean-Eric Tarride, Sangeeta Mehta, Avelino C Verceles, Brenda Reeve, Heather O'Grady, Laurel Kelly, Geoff Strong, Abby H Hurd, Lehana Thabane, Deborah J Cook, CYCLE Investigators and the Canadian Critical Care Trials Group

Abstract

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).

Keywords: adult intensive & critical care; clinical trials; rehabilitation medicine.

Conflict of interest statement

Competing interests: MEK received an equipment loan of 4 RT300 supine cycles from Restorative Therapies, Baltimore, Maryland, USA for this study. On behalf of the remaining authors, the corresponding author states there is no conflict of interest.

© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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