Functional electrical stimulation-assisted cycle ergometry in critically ill: Linking deranged muscle physiology to long-term functional outcome
Project goals
ICU acquired weakness contributes to poor functional outcome in survivors of critical care. Most damage occurs during the first week of critical illness when patients are unable to cooperate with conventional active rehabilitation. Functional electrical stimulation-assisted cycle ergometry (FES-CE) may improve muscle function and long-term outcome. Methods: Assessor-blinded pragmatic single-centre randomized controlled trial. Adults (n=150) mechanically ventilated for <48 hours from 4 ICUs who are estimated to need >7 days of critical care will be randomized to receive either FES-CE-based intensified rehabilitation or routine care, which will continue until ICU discharge. Primary outcome: Quality of life as measured by SF-36 score at 6 months. Secondary outcomes: functional performance at ICU discharge, cross sectional muscle diameter and nitrogen balance, and muscle power. In a subgroup we will assess insulin sensitivity and perform skeletal muscle biopsies to look at mitochondrial function, fibre typing and regulatory protein expression in response to FES-CE.
Keywords
časná rehabilitacesarkopeniesvalová slabostmitochondrieinzulínorezistenceearly rehabilitationmusle wastingweaknessmitochondriainsulin resistance
Public support
Provider
Ministry of Health
Programme
Programme to support medical applied research in 2015 to 2022
Call for proposals
Zdravotnický AV 2 (SMZ0201601)
Main participants
Univerzita Karlova / 3. lékařská fakulta
Contest type
VS - Public tender
Contract ID
16-28663A
Alternative language
Project name in Czech
Funkční elektrickou stimulací asistovaná bicyklová ergometrie u kriticky nemocných: vztah mezi fyziologií svalu a dlouhodobým funkčním výsledkem léčby
Annotation in Czech
Svalová slabost kriticky nemocných je nejdůležitější příčinou selhání dlouhodobého funkčního výsledku u přeživších. K jejímu rozvoji dochází již v průběhu prvního týdne pobytu, kdy nemocní nejsou schopni postupovat konvenční fyzioterapii. Hypotéza studie je, že velmi časná (<48 hod) rehabilitace s použitím bicyklové ergometrie asistované funkční elektrickou svalovou stimulací (FES-CE) zlepší kvalitu života pacientů po 6 měsících. Metody: Prospektivní randomizovaná kontrolovaná studie. Dospělí pacienti (n=150) ze 4 JIP ventilovaní <48 hodin s předpokládaným pobytem >7 dní na JIP budou randomizováni (1:1) do skupiny se standardní péčí, nebo do skupiny s intenzifikovanou rehabilitací (asistovanou FES-CE), která bude pokračovat do propuštění z JIP. Primární outcome: Kvalita života v 6 měsících dle SF-36. Sekundární outcome: svalová hmota (ultrazvuk quadricepsu, N-bilance) a funkce (MRC skóre, funkční zdatnost při propuštění z JIP). V podskupině (n=30) bude měřena citlivost k inzulínu a provedeny biopsie svalu k mitochondriálním funkčním testům, stanovení typizace vláken a genové expre...
Scientific branches
R&D category
AP - Applied research
CEP classification - main branch
FP - Other medical fields
CEP - secondary branch
—
CEP - another secondary branch
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30106 - Anatomy and morphology (plant science to be 1.6)
30107 - Medicinal chemistry
30108 - Toxicology
30109 - Pathology
30221 - Critical care medicine and Emergency medicine
30223 - Anaesthesiology
30224 - Radiology, nuclear medicine and medical imaging
30225 - Allergy
30226 - Rheumatology
30227 - Geriatrics and gerontology
30229 - Integrative and complementary medicine (alternative practice systems)
30230 - Other clinical medicine subjects
30307 - Nursing
30308 - Nutrition, Dietetics
30309 - Tropical medicine
30310 - Parasitology
30311 - Medical ethics
30312 - Substance abuse
30501 - Forensic science
30502 - Other medical science
Completed project evaluation
Provider evaluation
V - Vynikající výsledky projektu (s mezinárodním významem atd.)
Project results evaluation
1.The professional contribution of the project lies in the following scientific findings: A) A randomized controlled trial did not confirm the benefit of early protocoled physiotherapy based on functional electrical stimulation assisted bicycle ergometry (FESCE) methodology for the functional status (SF-36) of critically ill patients (n 150) in the ICU after 6 months (primary endpoint). Also, no difference was found in any of the parameters of the secondary endpoints, except for the parameter of the nitrogen balance. (B) In addition, in the intervention group (mean 84 minutes of rehabilitation intervention/day), there were increases in intracranial pressure (during the intervention) and poorer cognitive function at 6 months. C) Using an insulin clamp and muscle biopsies, a subgroup (n 31) analysis found that the intervention (using the above-mentioned early rehabilitation) did not affect the bioenergetic parameters of skeletal muscle, only there was a trend of lower insulin consump
Solution timeline
Realization period - beginning
Apr 1, 2016
Realization period - end
Dec 31, 2020
Project status
U - Finished project
Latest support payment
Jun 28, 2018
Data delivery to CEP
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data delivery code
CEP21-MZ0-NV-U/03:1
Data delivery date
Jun 25, 2021
Finance
Total approved costs
15,034 thou. CZK
Public financial support
14,240 thou. CZK
Other public sources
0 thou. CZK
Non public and foreign sources
502 thou. CZK
Basic information
Recognised costs
15 034 CZK thou.
Public support
14 240 CZK thou.
94%
Provider
Ministry of Health
CEP
FP - Other medical fields
Solution period
01. 04. 2016 - 31. 12. 2020