Objective To determine the safety and efficacy of aerobic exercise on activities of daily living in the subacute phase after stroke.
Design Multicentre, randomised controlled, endpoint blinded trial.
Setting Seven inpatient rehabilitation sites in Germany (2013-17).
Participants 200 adults with subacute stroke (days 5-45 after stroke) with a median National Institutes of Health stroke scale (NIHSS, range 0-42 points, higher values indicating more severe strokes) score of 8 (interquartile range 5-12) were randomly assigned (1:1) to aerobic physical fitness training (n=105) or relaxation sessions (n=95, control group) in addition to standard care.
Intervention Participants received either aerobic, bodyweight supported, treadmill based physical fitness training or relaxation sessions, each for 25 minutes, five times weekly for four weeks, in addition to standard rehabilitation therapy. Investigators and endpoint assessors were masked to treatment assignment.
Main outcome measures The primary outcomes were change in maximal walking speed (m/s) in the 10 m walking test and change in Barthel index scores (range 0-100 points, higher scores indicating less disability) three months after stroke compared with baseline. Safety outcomes were recurrent cardiovascular events, including stroke, hospital readmissions, and death within three months after stroke. Efficacy was tested with analysis of covariance for each primary outcome in the full analysis set. Multiple imputation was used to account for missing values.
Results Compared with relaxation, aerobic physical fitness training did not result in a significantly higher mean change in maximal walking speed (adjusted treatment effect 0.1 m/s (95% confidence interval 0.0 to 0.2 m/s), P=0.23) or mean change in Barthel index score (0 (−5 to 5), P=0.99) at three months after stroke. A higher rate of serious adverse events was observed in the aerobic group compared with relaxation group (incidence rate ratio 1.81, 95% confidence interval 0.97 to 3.36).
Conclusions Among moderately to severely affected adults with subacute stroke, aerobic bodyweight supported, treadmill based physical fitness training was not superior to relaxation sessions for maximal walking speed and Barthel index score but did suggest higher rates of adverse events. These results do not appear to support the use of aerobic bodyweight supported fitness training in people with subacute stroke to improve activities of daily living or maximal walking speed and should be considered in future guidelines.
Trial registration ClinicalTrials.gov NCT01953549.

目的确定有氧运动对卒中后亚急性期日常生活活动的安全性和有效性。
设计多中心，随机对照，终点盲法试验。在德国
设置七个住院康复站点（2013-17年）。
参与者200名亚急性中风（中风后5-45天）的成年人健康状况中风量表（NIHSS，范围为0-42分，较高的值表示更严重的中风）得分为8（四分位间距为5-12）除标准护理外，还随机分配（1：1）有氧体能训练（n = 105）或放松训练（n = 95，对照组）。
干涉除了标准的康复治疗外，参与者还接受有氧，体重支持，基于跑步机的体能训练或放松训练，每次训练25分钟，每周五次，共四个星期。研究者和终点评估者被掩盖了治疗分配。
主要观察指标主要结果是卒中后三个月与基线相比，在10 m步行测试中最大步行速度（m / s）的变化和Barthel指数得分的变化（范围为0-100点，较高的分数表示较少的残疾）。安全结局是复发性心血管事件，包括中风，住院再入院和中风后三个月内死亡。在整个分析集中对每个主要结局进行协方差分析，对功效进行了测试。使用多重插补来说明缺失值。
结果与放松相比，有氧体能训练并未导致最大步行速度的平均变化显着更高（调整后的治疗效果为0.1 m / s（95％置信区间0.0到0.2 m / s，P = 0.23））或平均变化。脑卒中后三个月的Barthel指数评分（0（-5至5），P = 0.99）。与放松组相比，有氧组的严重不良事件发生率更高（发生率比为1.81，95％置信区间为0.97至3.36）。
结论在中度至重度患亚急性中风的成年人中，有氧体重的支持，基于跑步机的体能训练在最大步行速度和Barthel指数评分方面并不优于放松训练，但确实提示了更高的不良事件发生率。这些结果似乎不支持在有重症的中风患者中使用有氧体重支持的体能训练来改善日常生活活动或最大步行速度，因此应在以后的指南中予以考虑。
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