Department of Anaesthesiology and Intensive Care Medicine, 3rd Faculty of Medicine and FNKV University Hospital, Charles University, Prague, Czech Republic.
Department of Rehabilitation, 3rd Faculty of Medicine and FNKV University Hospital, Charles University, Prague, Czech Republic.
Thorax. 2021 Jul;76(7):664-671. doi: 10.1136/thoraxjnl-2020-215755. Epub 2021 Apr 30.
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.
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.
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/m less negative in the intervention group.
Early delivery of FESCE-based protocolised rehabilitation to ICU patients does not improve physical functioning at 6 months in survivors.
NCT02864745.
功能性电刺激辅助自行车运动(FESCE)使患者能够在卧床时独立进行腿部运动,无需依赖患者的意志。我们假设,早期使用基于 FESCE 的渐进性移动计划可以改善重症监护后幸存者的身体功能,时间为 6 个月。
我们将预计需要 ICU 住院治疗> 7 天的机械通气成年人纳入一项评估者盲法、单中心、随机对照试验,以接受基于 FESCE 的方案或标准康复治疗,治疗持续时间最长可达 28 天或 ICU 出院。
我们以 1:1 的比例随机分配了 150 名患者(年龄 61±15 岁,急性生理学和慢性健康评估 II 21±7),中位数为 ICU 入院后 21(IQR 19-43)小时。干预组与对照组接受的康复治疗的平均康复时间分别为 82(IQR 66-97)和 53(IQR 50-57)分钟/治疗日,p<0.001。在 6 个月时,干预组和对照组分别有 42(56%)和 46(61%)名患者存活并可进行随访(占预设样本量的 81.5%)。他们的 SF-36 健康调查简表的身体成分综合得分(主要结局)在 6 个月时没有差异(50(IQR 21-69)与 49(IQR 26-77);p=0.26)。在 ICU 出院时,尽管干预组的每日氮平衡负差值为 0.6(95%CI 0.2 至 1.0;p=0.004)gN/m,但两组之间在 ICU 住院时间、功能表现、股直肌横截面积或肌肉力量方面没有差异。
早期向 ICU 患者提供基于 FESCE 的方案性康复治疗并不能改善幸存者 6 个月时的身体功能。
NCT02864745。