• Trials · Dec 2019

    Functional electrical stimulation-assisted cycle ergometry in the critically ill: protocol for a randomized controlled trial.

    • Petr Waldauf, Jan Gojda, Tomáš Urban, Natália Hrušková, Barbora Blahutová, Marie Hejnová, Kateřina Jiroutková, Michal Fric, Pavel Jánský, Jana Kukulová, Francis Stephens, Kamila Řasová, and František Duška.
    • Department of Anaesthesiology and Intensive Care Medicine, Charles University, 3rd Faculty of Medicine and KAR FNKV University Hospital, Fac Med 3, Srobarova 50, 10034, Prague, Czech Republic.
    • Trials. 2019 Dec 16; 20 (1): 724.

    BackgroundIntensive care unit (ICU)-acquired weakness is the most important cause of failed functional outcome in survivors of critical care. Most damage occurs during the first week when patients are not cooperative enough with conventional rehabilitation. Functional electrical stimulation-assisted cycle ergometry (FES-CE) applied within 48 h of ICU admission may improve muscle function and long-term outcome.MethodsAn assessor-blinded, pragmatic, single-centre randomized controlled trial will be performed. Adults (n = 150) mechanically ventilated for < 48 h from four ICUs who are estimated to need > 7 days of critical care will be randomized (1:1) to receive either standard of care or FES-CE-based intensified rehabilitation, which will continue until ICU discharge.Primary Outcomequality of life measured by 36-Item Short Form Health Survey score at 6 months.Secondary Outcomesfunctional performance at ICU discharge, muscle mass (vastus ultrasound, N-balance) and function (Medical Research Council score, insulin sensitivity). In a subgroup (n = 30) we will assess insulin sensitivity and perform skeletal muscle biopsies to look at mitochondrial function, fibre typing and regulatory protein expression.Trial RegistrationClinicalTrials.gov, NCT02864745. Registered on 12 August 2016.

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