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

Petr Waldauf, Jan Gojda, Tomáš Urban, Natália Hrušková, Barbora Blahutová, Marie Hejnová, Kateřina Jiroutková, Michal Fric, Pavel Jánský, Jana Kukulová, Francis Stephens, Kamila Řasová, František Duška, Petr Waldauf, Jan Gojda, Tomáš Urban, Natália Hrušková, Barbora Blahutová, Marie Hejnová, Kateřina Jiroutková, Michal Fric, Pavel Jánský, Jana Kukulová, Francis Stephens, Kamila Řasová, František Duška

Abstract

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.

Keywords: Critically ill; Early rehabilitation; Functional electrical stimulation-assisted cycle ergometry; Intensive care unit; Mobility; Physical therapy.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Planned flowchart of patients enrolled into the trial. D7 day 7, D/C discharge, FES-CE functional electrical stimulation-assisted cycle ergometry, ICU intensive care unit, tx treatment, NMS neuromuscular stimulation, PCBE passive cycling-based exercise
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure. D day, D/C discharge, EGDR early goal-directed rehabilitation, F-up follow-up, ICU intensive care unit, MRC Medical Research Council, MV mechanical ventilation, RHB rehabilitation, SF-36 Short Form 36, SOFA Sequential Organ Failure Assessment, CCS Charlson comorbidity score, ROM range of motion, PFIT physical function test for use in the intensive care unit
Fig. 3
Fig. 3
Protocol of intensified goal-directed rehabilitation. FES-CE functional electrical stimulation-assisted cycle ergometry, FIO2 fraction of inspired oxygen, LL lower limb, RASS Richmond Agitation and Sedation Scale, UL upper limb

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