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

Trials. 2019 Dec 16;20(1):724. doi: 10.1186/s13063-019-3745-1.


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:, NCT02864745. Registered on 12 August 2016.

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

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Bicycling*
  • Critical Illness
  • Czech Republic
  • Electric Stimulation Therapy* / adverse effects
  • Ergometry*
  • Exercise Test
  • Humans
  • Intensive Care Units
  • Muscle Contraction*
  • Muscle Strength*
  • Muscle Weakness / diagnosis
  • Muscle Weakness / physiopathology
  • Muscle Weakness / rehabilitation*
  • Muscle, Skeletal / innervation*
  • Pragmatic Clinical Trials as Topic
  • Quality of Life
  • Recovery of Function
  • Time Factors
  • Treatment Outcome

Associated data