Effect of In-Bed Leg Cycling and Electrical Stimulation of the Quadriceps on Global Muscle Strength in Critically III Adults A Randomized Clinical Trial
Effect of In-Bed Leg Cycling and Electrical Stimulation of the Quadriceps on Global Muscle Strength in Critically III Adults A Randomized Clinical Trial
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DOI：
10.1001/jama.2018.9592
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发表时间：
2018-07-24
影响因子：
120.7
通讯作者：
Boulain, Thierry
中科院分区：
文献类型：
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作者：
Fossat, Guillaume;Baudin, Florian;Boulain, Thierry
重要性早期床上骑自行车和电肌肉刺激可以改善重症监护室（ICU）患者的康复益处。目的研究早期床上骑自行车加电刺激股四头肌加入标准化早期康复是否会导致ICU出院时更大的肌肉力量。设计、设置和参与者单中心，在法国一家拥有1100张床位的医院中，一项随机临床试验招募了1名ICU重症成年患者。入组时间为2014年7月至2016年6月，随访6个月，于11月24日结束，干预患者被随机分配到早期床上腿部自行车加四头肌电刺激加标准化早期康复（n = 159）或单独标准化早期康复（常规护理）（n = 155）。主要结果和测量主要结果是由对治疗组不知情的物理治疗师使用医学研究理事会分级系统评估的从ICU出院时的肌肉力量（评分范围，0 - 60分;评分越高反映肌肉力量越好;最小临床重要差异为4分）。ICU出院时的次要结局包括无呼吸机天数和ICU活动性量表评分（范围，0 - 10;评分越高反映行走能力越好）。功能自主性和健康相关的生活quality进行了评估，在6 months.Results 314例随机患者中，312（平均年龄，66岁;女性，36%;接受机械通气在研究纳入，78%）完成了研究，并纳入分析。在ICU出院时，干预组的全球医学研究理事会评分中位数为48（四分位距[IQR]，29 - 58），常规护理组为51（IQR，37 - 58）（中位数差异，-3.0（95% CI，-7.0至2.8）; P = 0.28）。两组ICU出院时的ICU移动性量表评分均为6（IQR，3 - 9）（中位差异，0 [95% CI，-1至2]; P = 0.52）。干预组第28天无呼吸机天数的中位数为21（IQR，6 - 25），常规护理组为22（IQR，10 - 25）（中位数差异，1 [95% CI，-2至3]; P = 0.24）。干预组7例患者（4.4%）和常规护理组9例患者（5.8%）在动员过程中发生了具有临床意义的事件。有没有显着的组间差异的结果评估在6 months.Conclusions和RELEVANCE在这个单中心随机临床试验，涉及患者入住ICU，增加早期在床上腿部自行车运动和电刺激股四头肌的标准化早期康复计划没有改善全球肌肉力量在出院时从ICU。
IMPORTANCE Early in-bed cycling and electrical muscle stimulation may improve the benefits of rehabilitation in patients in the intensive care unit (ICU).OBJECTIVE To investigate whether early in-bed leg cycling plus electrical stimulation of the quadriceps muscles added to standardized early rehabilitation would result in greater muscle strength at discharge from the ICU.DESIGN, SETTING, AND PARTICIPANTS Single-center, randomized clinical trial enrolling critically ill adult patients at 1 ICU within an 1100-bed hospital in France. Enrollment lasted from July 2014 to June 2016 and there was a 6-month follow-up, which ended on November 24, 2016.INTERVENTIONS Patients were randomized to early in-bed leg cycling plus electrical stimulation of the quadriceps muscles added to standardized early rehabilitation (n = 159) or standardized early rehabilitation alone (usual care) (n = 155).MAIN OUTCOMES AND MEASURES The primary outcome was muscle strength at discharge from the ICU assessed by physiotherapists blinded to treatment group using the Medical Research Council grading system (score range, 0-60 points; a higher score reflects better muscle strength; minimal clinically important difference of 4 points). Secondary outcomes at ICU discharge included the number of ventilator-free days and ICU Mobility Scale score (range, 0-10; a higher score reflects better walking capability). Functional autonomy and health-related quality of life were assessed at 6 months.RESULTS Among 314 randomized patients, 312 (mean age, 66 years; women, 36%; receiving mechanical ventilation at study inclusion, 78%) completed the study and were included in the analysis. The median global Medical Research Council score at ICU discharge was 48 (interquartile range [IQR], 29 to 58) in the intervention group and 51(IQR, 37 to 58) in the usual care group (median difference, -3.0 [95% Cl, -7.0 to 2.8]; P = .28). The ICU Mobility Scale score at ICU discharge was 6 (IQR, 3 to 9) in both groups (median difference, 0 [95% Cl, -1 to 2]; P = .52). The median number of ventilator-free days at day 28 was 21(IQR, 6 to 25) in the intervention group and 22 (IQR, 10 to 25) in the usual care group (median difference, 1[95% Cl, -2 to 3]; P = .24). Clinically significant events occurred during mobilization sessions in 7 patients (4.4%) in the intervention group and in 9 patients (5.8%) in the usual care group. There were no significant between-group differences in the outcomes assessed at 6 months.CONCLUSIONS AND RELEVANCE In this single-center randomized clinical trial involving patients admitted to the ICU, adding early in-bed leg cycling exercises and electrical stimulation of the quadriceps muscles to a standardized early rehabilitation program did not improve global muscle strength at discharge from the ICU.