BACKGROUND: Intensive 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. METHODS: An 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 OUTCOME: quality of life measured by 36-Item Short Form Health Survey score at 6 months. SECONDARY OUTCOMES: functional 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 REGISTRATION: ClinicalTrials.gov, NCT02864745. Registered on 12 August 2016.

College of Life and Environmental Sciences Sport and Health Sciences University of Exeter Exeter UK

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

Department of Internal Medicine 2 Charles University 3rd Faculty of Medicine and FNKV University Hospital Prague Czech Republic

Department of Rehabilitation Charles University 3rd Faculty of Medicine and FNKV University Hospital Prague Czech Republic

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Inflammation and altered metabolism impede efficacy of functional electrical stimulation in critically ill patients

Functional electrical stimulation-assisted cycle ergometry-based progressive mobility programme for mechanically ventilated patients: randomised controlled trial with 6 months follow-up

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ClinicalTrials.gov
NCT02864745