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

Autor: Waldauf P; 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., Gojda J; Department of Internal Medicine II, Charles University, 3rd Faculty of Medicine and FNKV University Hospital, Prague, Czech Republic., Urban T; 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., Hrušková N; Department of Rehabilitation, Charles University, 3rd Faculty of Medicine and FNKV University Hospital, Prague, Czech Republic., Blahutová B; 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 Rehabilitation, Charles University, 3rd Faculty of Medicine and FNKV University Hospital, Prague, Czech Republic., Hejnová M; 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 Rehabilitation, Charles University, 3rd Faculty of Medicine and FNKV University Hospital, Prague, Czech Republic., Jiroutková K; 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., Fric M; 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., Jánský P; 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., Kukulová J; 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., Stephens F; College of Life and Environmental Sciences, Sport and Health Sciences, University of Exeter, Exeter, UK., Řasová K; Department of Rehabilitation, Charles University, 3rd Faculty of Medicine and FNKV University Hospital, Prague, Czech Republic., Duška F; 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. frantisek.duska@lf3.cuni.cz.
Jazyk: angličtina
Zdroj: Trials [Trials] 2019 Dec 16; Vol. 20 (1), pp. 724. Date of Electronic Publication: 2019 Dec 16.
DOI: 10.1186/s13063-019-3745-1
Abstrakt: 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.
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje