NCT03782389

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
Last Updated

December 20, 2018

Status Verified

December 1, 2018

Enrollment Period

4.9 years

First QC Date

December 12, 2018

Last Update Submit

December 18, 2018

Conditions

Keywords

Athleteinjury preventionmuscle strainpredictionprognosisscreeningsport

Outcome Measures

Primary Outcomes (1)

  • Number of participants with an indirect muscle injury.

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

    11 Months (1 football season)

Secondary Outcomes (3)

  • Number of participants with an indirect muscle injury affecting the hamstring muscle group.

    11 Months (1 football season)

  • 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)

Study Arms (1)

Elite football players aged 16-40 years

Other: Preseason Periodic Health Examination Completion

Interventions

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.

Elite football players aged 16-40 years

Eligibility Criteria

Age16 Years - 40 Years
Sexmale
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The population under study was of male elite football players aged 16-40 years old at an English Premier League club.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Hughes T, Riley R, Callaghan MJ, Sergeant JC. Can prognostic factors for indirect muscle injuries in elite football (soccer) players be identified using data from preseason screening? An exploratory analysis using routinely collected periodic health examination records. BMJ Open. 2023 Jan 24;13(1):e052772. doi: 10.1136/bmjopen-2021-052772.

  • Hughes T, Riley RD, Callaghan MJ, Sergeant JC. The Value of Preseason Screening for Injury Prediction: The Development and Internal Validation of a Multivariable Prognostic Model to Predict Indirect Muscle Injury Risk in Elite Football (Soccer) Players. Sports Med Open. 2020 May 27;6(1):22. doi: 10.1186/s40798-020-00249-8.

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physiotherapist and Clinical Lead

Study Record Dates

First Submitted

December 12, 2018

First Posted

December 20, 2018

Study Start

July 1, 2013

Primary Completion

May 19, 2018

Study Completion

May 19, 2018

Last Updated

December 20, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share