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

Abstract

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.

Keywords: complementary medicine; critical care.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Flowchart of patients enrolled into the trial. Each patient could have one or more reasons not to be included and therefore the sum of reasons exceed the number of patients excluded. Other reasons included missed patients due to logistical reasons or patients who were deemed unlikely to survive; all patients who had been enrolled based on legal representative assent and regained capacity, gave written informed consent by the end of the follow-up period. ICU, intensive care unit; LOS, length of stay

Figure 2

Protocol implementation indices. (A) Average duration of rehabilitation in intervention (blue line) and control (red line) groups in all days of all patients (ie, including days without rehabilitation). Thin lines are individual patients (one outlier received up to 180 min of rehabilitation a day due to protocol violation). (B) Sedation level heatmap. (C) Average types of exercise delivered daily. FESCE, functional electrical stimulation-assisted cycle ergometry; RASS, Richmond Agitation-Sedation Scale, where 0 (alert and calm) or −1 (drowsy) were target levels of sedation management.

Figure 3

(A) Physical component summary of SF-36 score (primary outcome); (B) Kaplan-Meier curve of survival in the study; (C) Kaplan-Meier curve of patients in the ICU (censored for non-survivors); (D) Kaplan-Meier curve of patients at hospital (censored for non-survivors). P values are from Wilcoxon in (A) and log-rank test in (B), (C) and (D). ICU, intensive care unit; LOS, length of stay; PCS, Physical Component Summary.