Lancet. 2015 Jul 4;386(9988):46-55. doi: 10.1016/S0140-6736(15)60690-0. Epub 2015 Apr 16.
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.
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.
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.
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.
National Health and Medical Research Council, Singapore Health, Chest Heart and Stroke Scotland, Northern Ireland Chest Heart and Stroke, UK Stroke Association, National Institute of Health Research.
人们认为卒中后早期活动有助于发挥卒中单元护理的效果；但是，干预措施的定义不明确，也没有强有力的证据支持。我们旨在比较频繁、高剂量、极早期活动与卒中后常规护理的效果。
我们在 5 个国家的 56 个急性卒中单元进行了这项平行分组、单盲、随机对照试验。纳入年龄≥18 岁、患有缺血性或出血性卒中（首次或复发）且符合生理标准的患者，通过基于网络的计算机生成的区组随机分组程序（区组大小为 6），以 1:1 的比例随机分配，接受常规卒中单元护理或在常规护理基础上加用极早期活动。允许使用重组组织型纤溶酶原激活剂。按照研究地点和卒中严重程度进行分层随机分组。患者、结局评估者和参与试验及数据管理的研究者对治疗分配设盲。主要结局为卒中后 3 个月时的良好结局，定义为改良 Rankin 量表评分为 0-2 分。我们基于意向治疗进行分析。该试验在澳大利亚新西兰临床试验注册中心注册，编号为 ACTRN12606000185561。
2006 年 7 月 18 日至 2014 年 10 月 16 日，我们随机分配 2104 例患者，分别接受极早期活动（n=1054）或常规护理（n=1050）；2083 例（99%）患者纳入 3 个月随访评估。在极早期活动组，965 例（92%）患者在 24 h 内进行了活动，而在常规护理组，623 例（59%）患者进行了活动。极早期活动组良好结局患者少于常规护理组（n=480[46%] vs n=525[50%]；调整后的比值比[OR]0·73，95%CI 0·59-0·90；p=0·004）。极早期活动组 88 例（8%）患者死亡，而常规护理组 72 例（7%）患者死亡（OR 1·34，95%CI 0·93-1·93，p=0·113）。极早期活动组 201 例（19%）患者和常规护理组 208 例（20%）患者发生非致死性严重不良事件，极早期活动并未减少与活动受限相关的并发症。
本试验中，大多数患者在 24 h 内首次进行活动。更高剂量的极早期活动方案与 3 个月时良好结局的可能性降低相关。卒中后早期活动在全球许多临床实践指南中都得到推荐，我们的研究结果应该通过完善目前的指南来影响临床实践；但是，临床建议应该根据剂量-反应关系的进一步分析来制定。
澳大利亚新西兰健康与医学研究理事会、新加坡卫生部、苏格兰胸心和卒中学会、北爱尔兰胸心和卒中学会、英国卒中协会、英国国家健康研究所。
