Dataset Information

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.

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).

SUBMITTER: Kho ME

PROVIDER: S-EPMC10314658 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Publications

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

Kho Michelle E ME Reid Julie J Molloy Alexander J AJ Herridge Margaret S MS Seely Andrew J AJ Rudkowski Jill C JC Buckingham Lisa L Heels-Ansdell Diane D Karachi Tim T Fox-Robichaud Alison A Ball Ian M IM Burns Karen E A KEA Pellizzari Joseph R JR Farley Christopher C Berney Sue S Pastva Amy M AM Rochwerg Bram B D'Aragon Frédérick F Lamontagne Francois F Duan Erick H EH Tsang Jennifer L Y JLY Archambault Patrick P English Shane W SW Muscedere John J Serri Karim K Tarride Jean-Eric JE Mehta Sangeeta S Verceles Avelino C AC Reeve Brenda B O'Grady Heather H Kelly Laurel L Strong Geoff G Hurd Abby H AH Thabane Lehana L Cook Deborah J DJ

BMJ open 20230623 6

<h4>Introduction</h4>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 critic ...[more]

PMID: 37355270

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