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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,
Language English Country Great Britain
Document type Clinical Trial Protocol, Journal Article
Grant support
AZV 16-28663A
Agentura Pro Zdravotnický Výzkum České Republiky
NV16-28663A
MZ0
CEP Register
Digital library NLK
Full text - Article
NLK
BioMedCentral
from 2000-04-01
BioMedCentral Open Access
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Directory of Open Access Journals
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Free Medical Journals
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PubMed Central
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Open Access Digital Library
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- MeSH
- Time Factors MeSH
- Bicycling * MeSH
- Electric Stimulation Therapy * adverse effects MeSH
- Ergometry * MeSH
- Intensive Care Units MeSH
- Muscle, Skeletal innervation MeSH
- Critical Illness MeSH
- Quality of Life MeSH
- Humans MeSH
- Recovery of Function MeSH
- Pragmatic Clinical Trials as Topic MeSH
- Muscle Contraction * MeSH
- Muscle Strength * MeSH
- Muscle Weakness diagnosis physiopathology rehabilitation MeSH
- Treatment Outcome MeSH
- Exercise Test MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial Protocol MeSH
- Geographicals
- Czech Republic MeSH
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.
References provided by Crossref.org
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