Ledoux Andrée-Anne, Barrowman Nick, Bijelić Vid, Borghese Michael M, Davis Adrienne, Reid Sarah, Sangha Gurinder, Yeates Keith Owen, Tremblay Mark S, McGahern Candice, Belanger Kevin, Barnes Joel D, Farion Ken J, DeMatteo Carol A, Reed Nick, Zemek Roger
Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada
Cellular and Molecular Medicine- Neuroscience, University of Ottawa, Ottawa, Ontario, Canada.
Br J Sports Med. 2022 Mar;56(5):271-278. doi: 10.1136/bjsports-2021-105030. Epub 2021 Nov 26.
Investigate whether resuming physical activity (PA) at 72 hours post concussion is safe and reduces symptoms at 2 weeks, compared with resting until asymptomatic.
Real-life conditions, multicentre, single-blinded randomised clinical trial, conducted in three Canadian paediatric emergency departments (ED). Children/youth aged 10-<18 years with acute concussion were recruited between March 2017 and December 2019, and randomly assigned to a 4-week stepwise return-to-PA protocol at 72 hours post concussion even if symptomatic (experimental group (EG)) or to a return-to-PA once asymptomatic protocol (control group (CG)). The primary outcome was self-reported symptoms at 2 weeks using the Health and Behaviour Inventory. Adherence was measured using accelerometers worn 24 hours/day for 14 days post injury. Adverse events (AE) (worsening of symptoms requiring unscheduled ED or primary care visit) were monitored. Multivariable intention-to-treat (ITT) and per-protocol analyses adjusting for prognostically important covariates were examined. Missing data were imputed for the ITT analysis.
456 randomised participants (EG: N=227; mean (SD) age=13.3 (2.1) years; 44.5% women; CG: N=229; mean (SD) age=13.3 (2.2) years; 43.7% women) were analysed. No AE were identified. ITT analysis showed no strong evidence of a group difference at 2 weeks (adjusted mean difference=-1.3 (95% CI:-3.6 to 1.1)). In adherent participants, initiating PA 72 hours post injury significantly reduced symptoms 2 weeks post injury, compared with rest (adjusted mean difference=-4.3 (95% CI:-8.4 to -0.2)).
Symptoms at 2 weeks did not differ significantly between children/youth randomised to initiate PA 72 hours post injury versus resting until asymptomatic; however, many were non-adherent to the intervention. Among adherent participants, early PA was associated with reduced symptoms at 2 weeks. Resumption of PA is safe and may be associated with milder symptoms at 2 weeks.
1b.
NCT02893969.
Pediatric Concussion Assessment of Rest and Exertion (PedCARE).
探讨与休息至无症状相比，脑震荡后72小时恢复体育活动（PA）是否安全以及能否在2周时减轻症状。
在加拿大三个儿科急诊科进行的真实环境、多中心、单盲随机临床试验。2017年3月至2019年12月招募了10-<18岁的急性脑震荡儿童/青少年，随机分配至脑震荡后72小时开始为期4周的逐步恢复PA方案（即使有症状）（实验组（EG））或无症状后恢复PA方案（对照组（CG））。主要结局是使用健康与行为量表在2周时自我报告的症状。使用受伤后14天每天佩戴24小时的加速度计测量依从性。监测不良事件（AE）（症状加重需要非计划的急诊科或初级保健就诊）。进行多变量意向性分析（ITT）和针对预后重要协变量进行调整的符合方案分析。ITT分析对缺失数据进行了插补。
分析了456名随机参与者（EG：N = 227；平均（标准差）年龄 = 13.3（2.1）岁；44.5%为女性；CG：N = 229；平均（标准差）年龄 = 13.3（2.2）岁；43.7%为女性）。未发现AE。ITT分析显示在2周时没有有力证据表明组间存在差异（调整后平均差异 = -1.3（95%CI：-3.6至1.1））。在依从的参与者中，与休息相比，受伤后72小时开始PA在受伤后2周时显著减轻了症状（调整后平均差异 = -4.3（95%CI：-8.4至 -0.2））。
随机分配在受伤后72小时开始PA的儿童/青少年与休息至无症状的儿童/青少年在2周时症状无显著差异；然而，许多人未依从干预。在依从的参与者中，早期PA与2周时症状减轻相关。恢复PA是安全的，并且可能与2周时症状较轻相关。
1b。
NCT0289396 .
儿童脑震荡休息与运动评估（PedCARE）。
