title: CYCLE pilot: a protocol for a pilot randomised study of early cycle ergometry versus routine physiotherapy in mechanically ventilated patients.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  NCT02377830; Pre-results.
authors.affiliation: McMaster University, School of Rehabilitation Science, Hamilton, Ontario, Canada Department of Physiotherapy, St. Joseph's Healthcare, Hamilton, Ontario, Canada Department of Physical Medicine and Rehabilitation, Johns Hopkins University, Baltimore, Maryland, USA.
authors.forename: Michelle E
authors.identifier: http://orcid.org/0000-0003-3170-031X
authors.initials: ME
authors.lastname: Kho
authors.affiliation: Department of Physiotherapy, St. Joseph's Healthcare, Hamilton, Ontario, Canada.
authors.forename: Alexander J
authors.initials: AJ
authors.lastname: Molloy
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
authors.forename: France
authors.initials: F
authors.lastname: Clarke
authors.affiliation: Department of Medicine, University of Toronto, Toronto General Research Institute, University Health Network, Toronto, Ontario, Canada.
authors.forename: Margaret S
authors.initials: MS
authors.lastname: Herridge
authors.affiliation: Swedish Early Mobility Program in Critical Care, Swedish Medical Group, First Hill Campus, Seattle, Washington, USA Department of Medicine, Western University, London, Ontario, Canada.
authors.forename: Karen K Y
authors.initials: KK
authors.lastname: Koo
authors.affiliation: Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Jill
authors.initials: J
authors.lastname: Rudkowski
authors.affiliation: Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: Andrew J E
authors.initials: AJ
authors.lastname: Seely
authors.affiliation: Consultation-Liaison Psychiatry Service, St. Joseph's Healthcare, Hamilton, Ontario, Canada Department of Psychiatry and Behavioural Neurosciences, McMaster University, Ontario, Canada.
authors.forename: Joseph R
authors.initials: JR
authors.lastname: Pellizzari
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada Programs for the Assessment of Technology in Health, Research Institute of St. Joe's Hamilton, Hamilton, Ontario, Canada.
authors.forename: Jean-Eric
authors.initials: JE
authors.lastname: Tarride
authors.affiliation: Department of Kinesiology, University of Waterloo, Waterloo, Ontario, Canada.
authors.forename: Marina
authors.initials: M
authors.lastname: Mourtzakis
authors.affiliation: Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Timothy
authors.initials: T
authors.lastname: Karachi
authors.affiliation: Department of Physical Medicine and Rehabilitation, Johns Hopkins University, Baltimore, Maryland, USA Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Deborah J
authors.initials: DJ
authors.lastname: Cook
mesh_terms: D000328:Adult; D001513:Beds; D002170:Canada; D002985:Clinical Protocols; D016638:Critical Illness / Q000534:rehabilitation* / Q000628:therapy; D015444:Exercise; D005081:Exercise Therapy / Q000379:methods*; D005240:Feasibility Studies; D006760:Hospitalization; D006801:Humans; D007362:Intensive Care Units; D053580:Muscle Strength; D026741:Physical Therapy Modalities; D010865:Pilot Projects; D052097:Quadriceps Muscle / Q000503:physiopathology*; D012107:Research Design; D012121:Respiration, Artificial
keywords: STATISTICS & RESEARCH METHODS