PT - JOURNAL ARTICLE AU - Petr Waldauf AU - Natália Hrušková AU - Barbora Blahutova AU - Jan Gojda AU - Tomáš Urban AU - Adéla Krajčová AU - Michal Fric AU - Kateřina Jiroutková AU - Kamila Řasová AU - František Duška TI - Functional electrical stimulation‐assisted cycle ergometry-based progressive mobility programme for mechanically ventilated patients: randomised controlled trial with 6 months follow-up AID - 10.1136/thoraxjnl-2020-215755 DP - 2021 Jul 01 TA - Thorax PG - 664--671 VI - 76 IP - 7 4099 - http://thorax.bmj.com/content/76/7/664.short 4100 - http://thorax.bmj.com/content/76/7/664.full SO - Thorax2021 Jul 01; 76 AB - Purpose Functional electrical stimulation-assisted cycle ergometry (FESCE) enables in-bed leg exercise independently of patients’ volition. We hypothesised that early use of FESCE-based progressive mobility programme improves physical function in survivors of critical care after 6 months.Methods We enrolled mechanically ventilated adults estimated to need >7 days of intensive care unit (ICU) stay into an assessor-blinded single centre randomised controlled trial to receive either FESCE-based protocolised or standard rehabilitation that continued up to day 28 or ICU discharge.Results We randomised in 1:1 ratio 150 patients (age 61±15 years, Acute Physiology and Chronic Health Evaluation II 21±7) at a median of 21 (IQR 19–43) hours after admission to ICU. Mean rehabilitation duration of rehabilitation delivered to intervention versus control group was 82 (IQR 66–97) versus 53 (IQR 50–57) min per treatment day, p<0.001. At 6 months 42 (56%) and 46 (61%) patients in interventional and control groups, respectively, were alive and available to follow-up (81.5% of prespecified sample size). Their Physical Component Summary of SF-36 (primary outcome) was not different at 6 months (50 (IQR 21–69) vs 49 (IQR 26–77); p=0.26). At ICU discharge, there were no differences in the ICU length of stay, functional performance, rectus femoris cross-sectional diameter or muscle power despite the daily nitrogen balance was being 0.6 (95% CI 0.2 to 1.0; p=0.004) gN/m2 less negative in the intervention group.Conclusion Early delivery of FESCE-based protocolised rehabilitation to ICU patients does not improve physical functioning at 6 months in survivors.Trial registration number NCT02864745.All data relevant to the study are included in the article or uploaded as supplementary information. We will sent de-identified patient-level data upon reasonable request to the corresponding author.