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

Abstract

BackgroundIntensive 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.MethodsAn 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 registrationClinicalTrials.gov, NCT02864745. Registered on 12 August 2016.

Functional electrical stimulation‐assisted cycle ergometry-based progressive mobility programme for mechanically ventilated patients: randomised controlled trial with 6 months follow-up

“…gov and the full protocol has been published. 32 We used a deferred consent procedure, where patients without capacity were enrolled based on assent gained from legal representatives and asked to provide consent as soon as they regained capacity.…”

“…Study subject characteristics IAPA ranges 0-8 with higher number meaning higher functional independence32 ; RAPA score ranges from 1 'I almost never do any physical activities' to 5 'I do 30 min or more per day of moderate physical activity 5 or more days per week'33 .…”

Inflammation and altered metabolism impede efficacy of functional electrical stimulation in critically ill patients

“…FES cycling was performed 90min/day for 7 days/week. Full details including ethical approval are available in the study protocol and the original publication [ 26 , 28 ].…”

Can functional electrical stimulation–assisted cycle ergometry replace insulin infusion in patients? A nested substudy in a randomized controlled trial with 6 months’ follow‐up

“…We performed an a priori planned secondary analysis of an outcome‐based, prospective, randomized controlled trial, Electric Mobility and Insulin Resistance (EMIR; ClinicalTrials.gov, NCT02864745), performed in the ICU of FNKV University Hospital in Prague, Czech Republic. Clinical outcomes are reported elsewhere [Waldauf, Thorax 2021], the full protocol of the study has been published, 7 and details can also be found in the supplementary materials.…”

“…Animal studies suggest that mechano‐signaling pathways exist in skeletal muscle and can circumvent molecular pathways affected by insulin resistance 6 . Technology advances, such as functional electrical stimulation–assisted cycle ergometry (FESCE), allow the delivery of active exercise even before the patient regains consciousness, 7,8 and it is tempting to hypothesize that compared with standard of care, an FESCE‐based early‐mobility program delivered to mechanically ventilated patients would reduce intravenous insulin requirements and increase insulin‐mediated glucose disposal during hyperinsulinemic clamp. In this study, we also aimed to investigate the dynamics of insulin sensitivity during and 6 months after critical illness.…”