Data from: Early sitting in ischemic stroke patients (SEVEL): a randomized controlled trial

Background: Extended immobility has been associated with medical complications during hospitalization. However no clear recommendations are available for mobilization of ischemic stroke patients. Objective: As early mobilization has been shown to be feasible and safe, we tested the hypothesis that early sitting could be beneficial to stroke patient outcome. Methods: This prospective multicenter study tested two sitting procedures at the acute phase of ischemic stroke, in a randomized controlled fashion (clinicaltrials.org registration number NCT01573299). Patients were eligible if they were above 18 years of age and showed no sign of massive infarction or any contra-indication for sitting. In the early-sitting group, patients were seated out of bed at the earliest possible time but no later than one calendar day after stroke onset, whereas the progressively-sitting group was first seated out of bed on the third calendar day after stroke onset. Primary outcome measure was the proportion of patients with a modified Rankin score [0–2] at 3 months post stroke. Secondary outcome measures were a.) prevalence of medical complications, b.) length of hospital stay, and c.) tolerance to the procedure. Results: One hundred sixty seven patients were included in the study, of which 29 were excluded after randomization. Data from 138 patients, 63 in the early-sitting group and 75 in the progressively-sitting group were analyzed. There was no difference regarding outcome of people with stroke, with a proportion of Rankin [0–2] score at 3 months of 76.2% and 77.3% of patients in the early- and progressive-sitting groups, respectively (p = 0.52). There was also no difference between groups for secondary outcome measures, and the procedure was well tolerated in both arms. Conclusion: Due to a slow enrollment, fewer patients than anticipated were available for analysis. As a result, we can only detect beneficial/detrimental effects of +/- 15% of the early sitting procedure on stroke outcome with a realized 37% power. However, enrollment was sufficient to rule out effect sizes greater than 25% with 80% power, indicating that early sitting is unlikely to have an extreme effect in either direction on stroke outcome. Additionally, we were not able to provide a blinded assessment of the primary outcome. Taking these limitations into account, our results may help guide the development of more effective acute stroke rehabilitation strategies, and the design of future acute stroke trials involving out of bed activities and other mobilization regimens.背景：长期卧床与住院期间的内科并发症密切相关，但目前尚无针对缺血性脑卒中（ischemic stroke）患者活动的明确临床推荐方案。 研究目的：鉴于早期活动已被证实具备可行性与安全性，本研究旨在验证早期坐位训练可改善脑卒中患者预后这一假说。 研究方法：本项前瞻性多中心随机对照研究，针对缺血性脑卒中急性期患者开展两种坐位训练方案的对比试验，注册于clinicaltrials.org，注册号为NCT01573299。入组标准为年龄≥18岁，无大面积脑梗死征象，且无坐位禁忌证。早期坐位组患者于卒中发病后最早可及时间离床坐位，且不晚于发病后1个自然日；渐进坐位组则于发病后第3个自然日首次离床坐位。主要结局指标为卒中发病后3个月时，改良Rankin量表（modified Rankin Scale, mRS）评分0~2分的患者占比。次要结局指标包括：a）内科并发症发生率；b）住院时长；c）训练方案的耐受性。 研究结果：本研究共纳入167例患者，其中29例在随机分组后被排除。最终纳入分析的患者共138例，早期坐位组63例，渐进坐位组75例。两组患者的卒中预后无显著差异：早期坐位组与渐进坐位组发病后3个月时改良Rankin量表评分0~2分的占比分别为76.2%与77.3%（p=0.52）。两组在次要结局指标上亦无显著差异，且两种训练方案的耐受性均良好。 研究结论：由于入组进度缓慢，最终纳入分析的患者数量少于预期。因此本研究仅能检测到早期坐位训练对卒中预后±15%幅度的有益/有害影响，实际检验效能为37%。但本研究的入组规模足以以80%的检验效能排除大于25%的效应量，提示早期坐位训练对卒中预后不太可能产生极端的正向或负向影响。此外，本研究未能对主要结局指标实施盲法评估。综合考虑上述局限性，本研究结果可为更有效的急性脑卒中康复策略的研发，以及未来涉及离床活动与其他活动方案的急性脑卒中试验设计提供参考依据。