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

P. Waldauf, J. Gojda, T. Urban, N. Hrušková, B. Blahutová, M. Hejnová, K. Jiroutková, M. Fric, P. Jánský, J. Kukulová, F. Stephens, K. Řasová, F. Duška,

. 2019 ; 20 (1) : 724. [pub] 20191216

Jazyk angličtina Země Velká Británie

Typ dokumentu protokol klinické studie, časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc20025400

Grantová podpora
AZV 16-28663A Agentura Pro Zdravotnický Výzkum České Republiky
NV16-28663A MZ0 CEP - Centrální evidence projektů

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.

Citace poskytuje Crossref.org

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