Waldauf 2019 Trials
| Waldauf P, Gojda J, Urban T, Hrušková N, Blahutová B, Hejnová M, Jiroutková K, Fric M, Jánský P, Kukulová J, Stephens F, Řasová K, Duška F (2019) Functional electrical stimulation-assisted cycle ergometry in the critically ill: protocol for a randomized controlled trial. Trials 20:724. |
Waldauf P, Gojda J, Urban T, Hruskova N, Blahutova B, Hejnova M, Jiroutkova K, Fric M, Jansky P, Kukulova J, Stephens F, Rasova K, Duska F (2019) Trials
Abstract: 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.
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.
The primary outcome will be the quality of life measured by 36-Item Short Form Health Survey score at 6 months.
The secondary outcome will be the 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. • Keywords: Critically ill, Early rehabilitation, Functional electrical stimulation-assisted cycle ergometry, Intensive care unit, Mobility, Physical therapy • Bioblast editor: Plangger M • O2k-Network Lab: CZ Prague Krajcova A
Labels: MiParea: Respiration, Exercise physiology;nutrition;life style, Patients
Organism: Human
Tissue;cell: Skeletal muscle
Preparation: Homogenate
HRR: Oxygraph-2k
Labels, 2020-01
