The Role of Periodic Health Examination in Determining Indirect Muscle Injury Risk in Elite Football (Soccer)
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|ClinicalTrials.gov Identifier: NCT03782389|
Recruitment Status : Completed
First Posted : December 20, 2018
Last Update Posted : December 20, 2018
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|Condition or disease||Intervention/treatment|
|Muscle Injury Sprains and Strains||Other: Preseason Periodic Health Examination Completion|
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.
|Study Type :||Observational|
|Actual Enrollment :||321 participants|
|Official Title:||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|
|Actual Study Start Date :||July 1, 2013|
|Actual Primary Completion Date :||May 19, 2018|
|Actual Study Completion Date :||May 19, 2018|
|Elite football players aged 16-40 years||
Other: Preseason Periodic Health Examination Completion
all available players completed a mandatory PHE on one of three days during the first week of the season. Typically, the musculoskeletal and performance components of the PHE included: 1) anthropometric measurements; 2) medical history (i.e. previous injury history); 3) musculoskeletal examination tests; 4) functional movement and balance tests; 5) strength and power tests.
- Number of participants with an indirect muscle injury. [ Time Frame: 11 Months (1 football season) ]Indirect muscle injury defined according to Terminology and Classification of Muscle Injuries Consensus Statement
- Number of participants with an indirect muscle injury affecting the hamstring muscle group. [ Time Frame: 11 Months (1 football season) ]If there is a sufficient number of outcomes, indirect muscle injuries (defined according to the Terminology and Classification of Muscle Injuries Consensus Statement) that affect the hamstring muscle group may be subgrouped and analysed accordingly.
- Number of participants with an indirect structural muscle injury. [ Time Frame: 11 Months (1 football season) ]If there is a sufficient number of outcomes, indirect muscle injuries will be categorised into structural injuries (defined as type 3 or 4 injury using the Terminology and Classification of Muscle Injuries Consensus Statement) and analysed accordingly.
- Number of participants with an indirect functional muscle injury. [ Time Frame: 11 Months (1 football season) ]If sufficient there is a sufficient number of outcomes, indirect muscle injuries will be categorised into functional injuries (defined as type 1a to 2b injuries using the Terminology and Classification of Muscle Injuries Consensus Statement) and analysed accordingly.
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|Ages Eligible for Study:||16 Years to 40 Years (Child, Adult)|
|Sexes Eligible for Study:||Male|
|Sampling Method:||Non-Probability Sample|
- had an outfield position (i.e. not a goalkeeper);
- participated in PHE testing for the relevant season.
- if players were on trial or not contracted to the club at the time of PHE.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782389
|Study Director:||Richard Riley, PhD||Centre for Prognosis Research, Keele University. UK|
|Study Director:||Jamie Sergeant, PhD||Arthritis Research UK Centre for Epidemiology, University of Manchester. UK.|
|Study Director:||Michael Callaghan, PhD||Dept of Health Professions, Manchester Metropolitan University. UK|
Documents provided by Tom Hughes, Manchester United Football Club:
|Responsible Party:||Tom Hughes, Senior Physiotherapist and Clinical Lead, Manchester United Football Club|
|Other Study ID Numbers:||
|First Posted:||December 20, 2018 Key Record Dates|
|Last Update Posted:||December 20, 2018|
|Last Verified:||December 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Wounds and Injuries
Sprains and Strains