Purpose To investigate the effect of functional electrical stimulation-assisted cycle ergometry (FES-cycling) on muscle strength, cognitive impairment and related outcomes.
Methods Mechanically ventilated patients aged ≥18 years with sepsis or systemic inflammatory response syndrome were randomised to either 60 min of FES-cycling >5 days/week while in the intensive care unit (ICU) plus usual care rehabilitation versus usual care rehabilitation alone, with evaluation of two primary outcomes: (1) muscle strength at hospital discharge and (2) cognitive impairment at 6-month follow-up.
Results We enrolled 162 participants, across four study sites experienced in ICU rehabilitation in Australia and the USA, to FES-cycling (n=80; mean age±SD 59±15) versus control (n=82; 56±14). Intervention participants received a median (IQR) of 5 (3–9) FES-cycling sessions with duration of 56 (34–63) min/day plus 15 (10–23) min/day of usual care rehabilitation. The control group received 15 (8–15) min/day of usual care rehabilitation. In the intervention versus control group, there was no significant differences for muscle strength at hospital discharge (mean difference (95% CI) 3.3 (−5.0 to 12.1) Nm), prevalence of cognitive impairment at 6 months (OR 1.1 (95% CI 0.30 to 3.8)) or secondary outcomes measured in-hospital and at 6 and 12 months follow-up.
Conclusion In this randomised controlled trial, undertaken at four centres with established rehabilitation programmes, the addition of FES-cycling to usual care rehabilitation did not substantially increase muscle strength at hospital discharge. At 6 months, the incidence of cognitive impairment was almost identical between groups, but potential benefit or harm of the intervention on cognition cannot be excluded due to imprecision of the estimated effect.
Trial registration number ACTRN 12612000528853, NCT02214823.
- critical care
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DMN and LD are joint senior authors.
Twitter @SueBerney, @PastvaAmy
DMN and LD contributed equally.
Contributors All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by SB, JWR, IG, EC, DMN and LD. The first draft of the manuscript was written by SB and all authors provided critical review and revision. All authors read and approved the final manuscript. SB and LD are guarantors of this paper.
Funding National Health and Medical Research Council of Australia, the Mrs. Sheila S. Pakula and Dr Lawrence C. Pakula Patient Recovery Fund in Pulmonary and Critical Care Medicine at Johns Hopkins University, The American Thoracic Society Foundation Unrestricted Research Grant (AMP); Intensive Care Foundation of Australia and Austin Health Medical Research Fund. Restorative Therapies provided the RT 300 supine cycle ergometer to the Austin Health site.
Competing interests ZP reports personal fees from Faraday Pharmaceuticals, Lyric Pharmaceuticals, Fresenius Kabi, Nestle, Orion, GlaxoSmithKline, outside the submitted work.
Patient consent for publication Not required.
Ethics approval The trial had ethical approval at all participating sites. Written informed consent was obtained from the participant or legally authorised representative (if participant was incapable, with continuation of consent obtained once capable). Study conduct was consistent with Good Clinical Practice Guidelines and the Declaration of Helsinki for protection of human subjects. This study was overseen by an independent data monitoring committee.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Deidentified participant data are available on reasonable request to Associate Professor Sue Berney (https://orcid.org/0000-0003-1633-805X).
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