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CYCLE pilot: a protocol for a pilot randomised study of early cycle ergometry versus routine physiotherapy in mechanically ventilated patients
  1. Michelle E Kho1,2,3,
  2. Alexander J Molloy2,
  3. France Clarke4,
  4. Margaret S Herridge5,
  5. Karen K Y Koo6,7,
  6. Jill Rudkowski8,
  7. Andrew J E Seely9,
  8. Joseph R Pellizzari10,11,
  9. Jean-Eric Tarride4,12,
  10. Marina Mourtzakis13,
  11. Timothy Karachi8,
  12. Deborah J Cook3,8,
  13. the Canadian Critical Care Trials Group
  1. 1McMaster University, School of Rehabilitation Science, Hamilton, Ontario, Canada
  2. 2Department of Physiotherapy, St. Joseph's Healthcare, Hamilton, Ontario, Canada
  3. 3Department of Physical Medicine and Rehabilitation, Johns Hopkins University, Baltimore, Maryland, USA
  4. 4Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
  5. 5Department of Medicine, University of Toronto, Toronto General Research Institute, University Health Network, Toronto, Ontario, Canada
  6. 6Swedish Early Mobility Program in Critical Care, Swedish Medical Group, First Hill Campus, Seattle, Washington, USA
  7. 7Department of Medicine, Western University, London, Ontario, Canada
  8. 8Department of Medicine, McMaster University, Hamilton, Ontario, Canada
  9. 9Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada
  10. 10Consultation-Liaison Psychiatry Service, St. Joseph's Healthcare, Hamilton, Ontario, Canada
  11. 11Department of Psychiatry and Behavioural Neurosciences, McMaster University, Ontario, Canada
  12. 12Programs for the Assessment of Technology in Health, Research Institute of St. Joe's Hamilton, Hamilton, Ontario, Canada
  13. 13Department of Kinesiology, University of Waterloo, Waterloo, Ontario, Canada
  1. Correspondence to Michelle E Kho; khome{at}mcmaster.ca

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.

  • STATISTICS & RESEARCH METHODS

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 and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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