Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial
Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial
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DOI：
10.1016/s0140-6736(15)60690-0
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发表时间：
2015-07-04
期刊：
影响因子：
168.9
通讯作者：
Donnan, Geoffrey
中科院分区：
文献类型：
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作者：
Bernhardt, Julie;Langhorne, Peter;Donnan, Geoffrey
背景：卒中后早期活动被认为有助于卒中单元护理的效果;然而，这种干预措施定义不清，也没有强有力的证据支持。我们的目的是比较频繁的，更高的剂量，非常早期动员与通常的照顾后stroke.Methods的有效性，我们做了这个平行组，单盲，随机对照试验，在56个急性中风单位在五个国家。通过基于网络的计算机生成的区组随机化程序（区组大小为6），将符合生理标准的首次或复发缺血性或出血性卒中患者（年龄≥ 18岁）随机分配（1：1），单独接受常规卒中单元护理或在常规护理基础上接受极早期动员。允许使用重组组织型纤溶酶原激活剂治疗。按照研究中心和卒中严重程度对随机化进行分层。患者、结局评估者和参与试验和数据管理的研究者均对治疗分配设盲。主要结局是卒中后3个月的有利结局，定义为改良兰金量表评分为0-2分。我们在意向治疗的基础上进行了分析。该试验在澳大利亚新西兰临床试验注册处注册，编号ACTRN 12606000185561。结果在2006年7月18日至2014年10月16日期间，我们将2104名患者随机分配接受极早期动员（n=1054）或常规护理（n=1050）; 2083例（99%）患者纳入3个月随访评估。极早期动员组中有965例（92%）患者在24小时内动员，而常规护理组中有623例（59%）患者。极早期动员组中获得良好结局的患者少于常规治疗组（n=480 [46%] vs n=525 [50%];校正比值比[OR] 0.73，95% CI 0.59-0.90; p=0.004）。极早期动员组有88例（8%）患者死亡，而常规治疗组有72例（7%）患者死亡（OR 1.34，95% CI 0.93-1.93，p=0.113）。201（19%）例患者在非常早期动员组和208（20%）的那些在常规护理组有一个非致命的严重不良事件，与不动相关的并发症与非常早期mobilisation.Interpretation解释首次动员发生在24小时内为大多数患者在本试验中。更高剂量的早期动员方案与3个月时有利结局的几率降低相关。世界各地的许多临床实践指南都建议卒中后早期活动，我们的研究结果应通过完善现有指南来影响临床实践;然而，临床建议应通过未来的剂量-反应相关性分析来了解。
Background Early mobilisation after stroke is thought to contribute to the effects of stroke-unit care; however, the intervention is poorly defined and not underpinned by strong evidence. We aimed to compare the effectiveness of frequent, higher dose, very early mobilisation with usual care after stroke.Methods We did this parallel-group, single-blind, randomised controlled trial at 56 acute stroke units in five countries. Patients (aged >= 18 years) with ischaemic or haemorrhagic stroke, first or recurrent, who met physiological criteria were randomly assigned (1: 1), via a web-based computer generated block randomisation procedure (block size of six), to receive usual stroke-unit care alone or very early mobilisation in addition to usual care. Treatment with recombinant tissue plasminogen activator was allowed. Randomisation was stratified by study site and stroke severity. Patients, outcome assessors, and investigators involved in trial and data management were masked to treatment allocation. The primary outcome was a favourable outcome 3 months after stroke, defined as a modified Rankin Scale score of 0-2. We did analysis on an intention-to-treat basis. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12606000185561.Findings Between July 18, 2006, and Oct 16, 2014, we randomly assigned 2104 patients to receive either very early mobilisation (n=1054) or usual care (n=1050); 2083 (99%) patients were included in the 3 month follow-up assessment. 965 (92%) patients were mobilised within 24 h in the very early mobilisation group compared with 623 (59%) patients in the usual care group. Fewer patients in the very early mobilisation group had a favourable outcome than those in the usual care group (n=480 [46%] vs n=525 [50%]; adjusted odds ratio [OR] 0.73, 95% CI 0.59-0.90; p=0.004). 88 (8%) patients died in the very early mobilisation group compared with 72 (7%) patients in the usual care group (OR 1.34, 95% CI 0.93-1.93, p=0.113). 201 (19%) patients in the very early mobilisation group and 208 (20%) of those in the usual care group had a non-fatal serious adverse event, with no reduction in immobility-related complications with very early mobilisation.Interpretation First mobilisation took place within 24 h for most patients in this trial. The higher dose, very early mobilisation protocol was associated with a reduction in the odds of a favourable outcome at 3 months. Early mobilisation after stroke is recommended in many clinical practice guidelines worldwide, and our findings should affect clinical practice by refining present guidelines; however, clinical recommendations should be informed by future analyses of dose-response associations.