评价一项针对参与澳式足球的女性和女孩的伤害预防计划(Prep-to-Play):一项实用、III 型、混合实施效果、阶梯式、群组随机对照试验的设计。
Evaluation of an injury prevention programme (Prep-to-Play) in women and girls playing Australian Football: design of a pragmatic, type III, hybrid implementation-effectiveness, stepped-wedge, cluster randomised controlled trial.
机构信息
Australian IOC Research Centre, La Trobe University Sport and Exercise Medicine Research Centre, Bundoora, Victoria, Australia
Centre for Sport and Social Impact, La Trobe University, Melbourne, Victoria, Australia.
出版信息
BMJ Open. 2022 Sep 14;12(9):e062483. doi: 10.1136/bmjopen-2022-062483.
INTRODUCTION
Due to the increase in participation and risk of anterior cruciate ligament (ACL) injuries and concussion in women's Australian Football, an injury prevention programme (Prep-to-Play) was codesigned with consumers (eg, coaches, players) and stakeholders (eg, the Australian Football League). The impact of supported and unsupported interventions on the use of Prep-to-Play (primary aim) and injury rates (secondary aim) will be evaluated in women and girls playing community Australian Football.
METHODS AND ANALYSIS
This stepped-wedge, cluster randomised controlled trial will include ≥140 teams from U16, U18 or senior women's competitions. All 10 geographically separated clusters (each containing ≥14 teams) will start in the control (unsupported) phase and be randomised to one of five dates (or 'wedges') during the 2021 or 2022 season to sequentially transition to the intervention (supported Prep-to-Play), until all teams receive the intervention. Prep-to-Play includes four elements: a neuromuscular training warm-up, contact-focussed football skills (eg, tackling), strength exercises and education (eg, technique cues). When transitioning to supported interventions, study physiotherapists will deliver a workshop to coaches and player leaders on how to use Prep-to-Play, attend team training at least two times and provide ongoing support. In the unsupported phase, team will continue usual routines and may freely access available Prep-to-Play resources online (eg, posters and videos about the four elements), but without additional face-to-face support. Outcomes will be evaluated throughout the 2021 and 2022 seasons (~14 weeks per season).
PRIMARY OUTCOME
use of Prep-to-Play will be reported via a team designate (weekly) and an independent observer (five visits over the two seasons) and defined as the team completing 75% of the programme, two-thirds (67%) of the time.
SECONDARY OUTCOMES
injuries will be reported by the team sports trainer and/or players. Injury definition: any injury occurring during a football match or training that results in: (1) being unable to return to the field of play for that match or (2) missing ≥ one match. Outcomes in the supported and unsupported phases will be compared using a generalised linear mixed model adjusting for clustering and time. Due to the type III hybrid implementation-effectiveness design, the study is powered to detect a improvement in use of Prep-to-Play a reduction in ACL injuries.
ETHICS AND DISSEMINATION
La Trobe University Ethics Committee (HREC 20488) approved. Coaches provided informed consent to receive the supported intervention and players provided consent to be contacted if they sustained a head or knee injury. Results will be disseminated through partner organisations, peer-reviewed publications and scientific conferences.
TRIAL REGISTRATION NUMBER
NCT04856241.
简介
由于女子澳大利亚足球中参与度的增加和前交叉韧带 (ACL) 损伤及脑震荡的风险增加,与消费者(如教练、球员)和利益相关者(如澳大利亚足球联盟)共同设计了一项损伤预防计划(Prep-to-Play)。本研究将评估在参与社区澳大利亚足球的女性和女孩中,支持和不支持干预措施对 Prep-to-Play 的使用(主要目标)和损伤率(次要目标)的影响。
方法和分析
这是一项阶梯式、整群随机对照试验,将纳入来自 U16、U18 或高级女子比赛的≥140 支球队。所有 10 个地理分离的群组(每个群组包含≥14 支球队)都将在对照(不支持)阶段开始,并在 2021 或 2022 赛季的五个日期(或“楔形”)之一随机分组,以顺序过渡到干预(支持的 Prep-to-Play),直到所有球队都接受干预。Prep-to-Play 包括四个要素:神经肌肉训练热身、以接触为重点的足球技能(如擒抱)、力量练习和教育(如技术提示)。在过渡到支持性干预时,研究理疗师将向教练和球员领袖举办一场关于如何使用 Prep-to-Play 的研讨会,至少参加两次团队培训,并提供持续支持。在不支持的阶段,球队将继续其常规流程,并且可以自由访问在线上可用的 Prep-to-Play 资源(例如,关于四个要素的海报和视频),但没有额外的面对面支持。结果将在整个 2021 和 2022 赛季进行评估(每个赛季约 14 周)。
主要结局
通过团队指定人员(每周)和独立观察员(两个赛季中的五次访问)报告 Prep-to-Play 的使用情况,并将其定义为完成计划 75%的团队,完成时间达到三分之二(67%)。
次要结局
球队运动训练员和/或球员将报告损伤情况。损伤定义:在足球比赛或训练中发生的任何导致以下情况的损伤:(1)无法返回该比赛的比赛场地;或(2)错过≥一场比赛。在支持和不支持阶段的结果将使用调整聚类和时间的广义线性混合模型进行比较。由于采用了 III 型混合实施有效性设计,该研究的目的是检测 Prep-to-Play 使用情况的改善,ACL 损伤的减少。
伦理和传播
拉筹伯大学伦理委员会(HREC 20488)批准。教练同意接受支持性干预,球员同意在头部或膝盖受伤时接受联系。结果将通过合作伙伴组织、同行评议的出版物和科学会议进行传播。
试验注册号
NCT04856241。