Multicentre, randomised clinical trial of paediatric concussion assessment of rest and exertion (PedCARE): a study to determine when to resume physical activities following concussion in children
Multicentre, randomised clinical trial of paediatric concussion assessment of rest and exertion (PedCARE): a study to determine when to resume physical activities following concussion in children
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DOI：
10.1136/bjsports-2017-097981
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发表时间：
2019-02-01
影响因子：
18.4
通讯作者：
Zemek, Roger
中科院分区：
文献类型：
--
作者：
Ledoux, Andree-Anne;Barrowman, Nicholas J.;Zemek, Roger
休息直到症状消失，然后逐步恢复活动，通常是在儿科脑震荡的管理规定。最近的证据表明，长时间的休息可能会阻碍恢复，尽早恢复体力活动可能与脑震荡后更快的恢复有关。主要目的是确定与休息直至无症状方案相比，在急性脑震荡后72小时开始早期恢复非接触性体育活动是否能减轻2周后的脑震荡后症状。方法和分析本研究是一项随机临床试验，横跨加拿大三个学术儿科急诊科。共有350名参与者，年龄10-17.99岁，在急性脑震荡48小时内出现，将被招募并随机分配到研究干预方案（即使出现症状，也要在脑震荡后72小时恢复体力活动）或身体休息直到完全无症状。参与者将记录他们的日常身体和认知活动。随访问卷将于伤后1、2和4周完成。使用加速度计测量干预的依从性（每天24小时，持续14天）。将使用经过验证的健康和行为清单测量症状。一个线性多变量模型，调整地点和预后重要协变量，将进行测试，以确定组间的差异。建议的方案遵循RCT-CONSORT指南。本试验将确定脑震荡后早期恢复非接触性体育活动是否能减轻脑震荡的负担，并将为医疗保健专业人员提供证据，以推荐重新引入体育活动的最佳时机。
Introduction Rest until symptom-free, followed by a progressive stepwise return to activities, is often prescribed in the management of paediatric concussions. Recent evidence suggests prolonged rest may hinder recovery, and early resumption of physical activity may be associated with more rapid recovery postconcussion. The primary objective is to determine whether the early reintroduction of non-contact physical activity beginning 72 hours postinjury reduces postconcussive symptoms at 2 weeks in children following an acute concussion as compared with a rest until asymptomatic protocol.Methods and analysis This study is a randomised clinical trial across three Canadian academic paediatric emergency departments. A total of 350 participants, aged 10-17.99 years, who present within 48 hours of an acute concussion, will be recruited and randomly assigned to either the study intervention protocol (resumption of physical activity 72 hours postconcussion even if experiencing symptoms) or physical rest until fully asymptomatic. Participants will document their daily physical and cognitive activities. Follow-up questionnaires will be completed at 1, 2 and 4 weeks postinjury. Compliance with the intervention will be measured using an accelerometer (24 hours/day for 14 days). Symptoms will be measured using the validated Health and Behaviour Inventory. A linear multivariable model, adjusting for site and prognostically important covariates, will be tested to determine differences between groups. The proposed protocol adheres to the RCT-CONSORT guidelines.Discussion This trial will determine if early resumption of non-contact physical activity following concussion reduces the burden of concussion and will provide healthcare professionals with the evidence by which to recommend the best timing of reintroducing physical activities.