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Trials ; 20(1): 724, 2019 Dec 16.
Artículo en Inglés | MEDLINE | ID: mdl-31842936

RESUMEN

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.


Asunto(s)
Ciclismo , Terapia por Estimulación Eléctrica , Ergometría , Contracción Muscular , Fuerza Muscular , Debilidad Muscular/rehabilitación , Músculo Esquelético/inervación , Enfermedad Crítica , República Checa , Terapia por Estimulación Eléctrica/efectos adversos , Prueba de Esfuerzo , Humanos , Unidades de Cuidados Intensivos , Debilidad Muscular/diagnóstico , Debilidad Muscular/fisiopatología , Ensayos Clínicos Pragmáticos como Asunto , Calidad de Vida , Recuperación de la Función , Factores de Tiempo , Resultado del Tratamiento
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