Herisson Fanny, Godard Sophie, Volteau Christelle, Le Blanc Emilie, Guillon Benoit, Gaudron Marie
Department of Neurology and Stroke Unit, Nantes University Hospital, Nantes, France.
Department of Neurology and Stroke Unit, Angers University Hospital, Angers, France.
PLoS One. 2016 Mar 29;11(3):e0149466. doi: 10.1371/journal.pone.0149466. eCollection 2016.
Extended immobility has been associated with medical complications during hospitalization. However no clear recommendations are available for mobilization of ischemic stroke patients.
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.
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.
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.
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.
ClinicalTrials.gov NCT01573299.
长期卧床与住院期间的医学并发症相关。然而，对于缺血性中风患者的活动安排尚无明确建议。
由于早期活动已被证明是可行且安全的，我们检验了早期坐立对中风患者预后有益的假设。
这项前瞻性多中心研究以随机对照方式，在缺血性中风急性期测试了两种坐立程序（clinicaltrials.org注册号NCT01573299）。年龄在18岁以上且无大面积梗死迹象或坐立无任何禁忌症的患者符合入选条件。在早期坐立组，患者在尽可能早但不迟于中风发作后一个日历日起床坐立，而逐渐坐立组在中风发作后第三个日历日首次起床坐立。主要结局指标是中风后3个月改良Rankin评分[0 - 2]的患者比例。次要结局指标包括：a）医学并发症的发生率，b）住院时间，c）对该程序的耐受性。
167例患者纳入研究，其中29例在随机分组后被排除。分析了138例患者的数据，早期坐立组63例，逐渐坐立组75例。中风患者的预后无差异，早期坐立组和逐渐坐立组3个月时Rankin[0 - 2]评分的患者比例分别为76.2%和77.3%（p = 0.52）。次要结局指标在两组间也无差异，且两组对该程序的耐受性均良好。
由于入组缓慢，可供分析的患者少于预期。因此，我们仅能以37%的检验效能检测早期坐立程序对中风预后±15%的有益/有害影响。然而，入组人数足以以80%的检验效能排除大于25%的效应量，表明早期坐立不太可能对中风预后产生极端影响。此外，我们无法对主要结局进行盲法评估。考虑到这些局限性，我们的结果可能有助于指导制定更有效的急性中风康复策略，以及设计未来涉及起床活动和其他活动方案的急性中风试验。
ClinicalTrials.gov NCT01573299。
