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临床试验/NCT03782389
NCT03782389已完成不适用

The Role of Periodic Health Examination in Determining Lower Extremity Muscle Injury Risk in Elite Football (Soccer): A Protocol for an Investigation Into Multivariable Prognostic Model Development, Validation and Prognostic Factor Exploration

Manchester United Football Club0 个研究点目标入组 321 人开始时间: 2013年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
321
主要终点
Number of participants with an indirect muscle injury.

研究概览

简要总结

Preseason periodic health examination (PHE) is used routinely in elite football (soccer) and can be used to inform injury prevention strategies. Indirect muscle injuries (IMI) are a considerable burden to elite teams. This investigation aims to evaluate whether measurements from PHE can be used in a multivariable model to predict IMI risk in elite players, or to establish prognostic factors that are associated with IMIs.

详细描述

BACKGROUND Indirect muscle injuries (IMIs) are a considerable burden to elite football (soccer) teams and prevention of these injuries offers many benefits. Preseason medical, musculoskeletal and performance screening (termed periodic health examination (PHE)) is used to help determine players at risk of injuries such as IMIs, where identification of PHE-derived prognostic factors (PF) may inform IMI prevention strategies. Furthermore, using several PFs in combination within a multivariable prognostic model may allow individualised IMI risk estimation and specific targeting of prevention strategies, based upon an individual's PF profile. No such models have been developed in elite football and the current IMI prognostic factor evidence is limited. This study aims to: 1) to develop and internally validate a prognostic model for individualised IMI risk prediction during a season in elite footballers, using the extent of the prognostic evidence and clinical reasoning; 2) explore potential PHE-derived PFs associated with IMI outcomes in elite footballers, using available PHE data from a professional team.

METHODS A retrospective review has been completed of PHE and injury data, routinely collected over 5 years (from 1st July 2013 to 19th May 2018) from a population of elite male players at an English Premier League football club. Of 60 candidate PFs, 15 were excluded. Ten factors will be included in model development, identified from a systematic review, missing data assessment, measurement reliability evaluation and clinical reasoning. A full multivariable logistic regression model will be fitted, to ensure adjustment before backward elimination. The performance and internal validation of the model will be assessed. The remaining 35 candidate PFs are eligible for further exploration, using univariable logistic regression to obtain unadjusted risk estimates. Exploratory PFs will be grouped according to type and incorporated into multivariable logistic regression models to determine risk estimates.

DISCUSSION This study will offer insights into clinical usefulness of a model to predict IMI risk in elite football and highlight the practicalities of model development in this setting. Exploration may identify other relevant PFs for future confirmatory studies, model updating, or influence future injury prevention research.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 40 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • had an outfield position (i.e. not a goalkeeper);
  • participated in PHE testing for the relevant season.

排除标准

  • if players were on trial or not contracted to the club at the time of PHE.

结局指标

主要结局

Number of participants with an indirect muscle injury.

时间窗: 11 Months (1 football season)

Indirect muscle injury defined according to Terminology and Classification of Muscle Injuries Consensus Statement

次要结局

  • Number of participants with an indirect structural muscle injury.(11 Months (1 football season))
  • Number of participants with an indirect functional muscle injury.(11 Months (1 football season))
  • Number of participants with an indirect muscle injury affecting the hamstring muscle group.(11 Months (1 football season))

研究者

发起方
Manchester United Football Club
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tom Hughes

Senior Physiotherapist and Clinical Lead

Manchester United Football Club

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