• Michelle E Kho, Alexander J Molloy, France Clarke, Margaret S Herridge, Karen K Y Koo, Jill Rudkowski, Andrew J E Seely, Joseph R Pellizzari, Jean-Eric Tarride, Marina Mourtzakis, Timothy Karachi, Deborah J Cook, and Canadian Critical Care Trials Group.
• 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.
• BMJ Open. 2016 Apr 8; 6 (4): e011659.

IntroductionEarly 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 Analysis60-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 DisseminationEach 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 NumberNCT02377830; Pre-results.Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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