<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03782389</url>
  </required_header>
  <id_info>
    <org_study_id>MUFC1</org_study_id>
    <nct_id>NCT03782389</nct_id>
  </id_info>
  <brief_title>The Role of Periodic Health Examination in Determining Indirect Muscle Injury Risk in Elite Football (Soccer)</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Manchester United Football Club</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Keele University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Manchester Metropolitan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Manchester United Football Club</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Preseason periodic health examination (PHE) is used routinely in elite football (soccer) and&#xD;
      can be used to inform injury prevention strategies. Indirect muscle injuries (IMI) are a&#xD;
      considerable burden to elite teams. This investigation aims to evaluate whether measurements&#xD;
      from PHE can be used in a multivariable model to predict IMI risk in elite players, or to&#xD;
      establish prognostic factors that are associated with IMIs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND Indirect muscle injuries (IMIs) are a considerable burden to elite football&#xD;
      (soccer) teams and prevention of these injuries offers many benefits. Preseason medical,&#xD;
      musculoskeletal and performance screening (termed periodic health examination (PHE)) is used&#xD;
      to help determine players at risk of injuries such as IMIs, where identification of&#xD;
      PHE-derived prognostic factors (PF) may inform IMI prevention strategies. Furthermore, using&#xD;
      several PFs in combination within a multivariable prognostic model may allow individualised&#xD;
      IMI risk estimation and specific targeting of prevention strategies, based upon an&#xD;
      individual's PF profile. No such models have been developed in elite football and the current&#xD;
      IMI prognostic factor evidence is limited. This study aims to: 1) to develop and internally&#xD;
      validate a prognostic model for individualised IMI risk prediction during a season in elite&#xD;
      footballers, using the extent of the prognostic evidence and clinical reasoning; 2) explore&#xD;
      potential PHE-derived PFs associated with IMI outcomes in elite footballers, using available&#xD;
      PHE data from a professional team.&#xD;
&#xD;
      METHODS A retrospective review has been completed of PHE and injury data, routinely collected&#xD;
      over 5 years (from 1st July 2013 to 19th May 2018) from a population of elite male players at&#xD;
      an English Premier League football club. Of 60 candidate PFs, 15 were excluded. Ten factors&#xD;
      will be included in model development, identified from a systematic review, missing data&#xD;
      assessment, measurement reliability evaluation and clinical reasoning. A full multivariable&#xD;
      logistic regression model will be fitted, to ensure adjustment before backward elimination.&#xD;
      The performance and internal validation of the model will be assessed. The remaining 35&#xD;
      candidate PFs are eligible for further exploration, using univariable logistic regression to&#xD;
      obtain unadjusted risk estimates. Exploratory PFs will be grouped according to type and&#xD;
      incorporated into multivariable logistic regression models to determine risk estimates.&#xD;
&#xD;
      DISCUSSION This study will offer insights into clinical usefulness of a model to predict IMI&#xD;
      risk in elite football and highlight the practicalities of model development in this setting.&#xD;
      Exploration may identify other relevant PFs for future confirmatory studies, model updating,&#xD;
      or influence future injury prevention research.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2013</start_date>
  <completion_date type="Actual">May 19, 2018</completion_date>
  <primary_completion_date type="Actual">May 19, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with an indirect muscle injury.</measure>
    <time_frame>11 Months (1 football season)</time_frame>
    <description>Indirect muscle injury defined according to Terminology and Classification of Muscle Injuries Consensus Statement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with an indirect muscle injury affecting the hamstring muscle group.</measure>
    <time_frame>11 Months (1 football season)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with an indirect structural muscle injury.</measure>
    <time_frame>11 Months (1 football season)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with an indirect functional muscle injury.</measure>
    <time_frame>11 Months (1 football season)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">321</enrollment>
  <condition>Muscle Injury</condition>
  <condition>Sprains and Strains</condition>
  <arm_group>
    <arm_group_label>Elite football players aged 16-40 years</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Preseason Periodic Health Examination Completion</intervention_name>
    <description>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.</description>
    <arm_group_label>Elite football players aged 16-40 years</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The population under study was of male elite football players aged 16-40 years old at an&#xD;
        English Premier League club.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  had an outfield position (i.e. not a goalkeeper);&#xD;
&#xD;
          -  participated in PHE testing for the relevant season.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - if players were on trial or not contracted to the club at the time of PHE.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Richard Riley, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Centre for Prognosis Research, Keele University. UK</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jamie Sergeant, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Arthritis Research UK Centre for Epidemiology, University of Manchester. UK.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Callaghan, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Dept of Health Professions, Manchester Metropolitan University. UK</affiliation>
  </overall_official>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Manchester United Football Club</investigator_affiliation>
    <investigator_full_name>Tom Hughes</investigator_full_name>
    <investigator_title>Senior Physiotherapist and Clinical Lead</investigator_title>
  </responsible_party>
  <keyword>Athlete</keyword>
  <keyword>injury prevention</keyword>
  <keyword>muscle strain</keyword>
  <keyword>prediction</keyword>
  <keyword>prognosis</keyword>
  <keyword>screening</keyword>
  <keyword>sport</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Sprains and Strains</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03782389/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03782389
org study id: MUFC1
nct id: NCT03782389
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Retrospective
measure: Number of participants with an indirect muscle injury.
time frame: 11 Months (1 football season)
description: Indirect muscle injury defined according to Terminology and Classification of Muscle Injuries Consensus Statement
measure: Number of participants with an indirect muscle injury affecting the hamstring muscle group.
time frame: 11 Months (1 football season)
description: 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.
measure: Number of participants with an indirect structural muscle injury.
time frame: 11 Months (1 football season)
description: 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.
measure: Number of participants with an indirect functional muscle injury.
time frame: 11 Months (1 football season)
description: 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.
arm group label: Elite football players aged 16-40 years
intervention type: Other
intervention name: Preseason Periodic Health Examination Completion
description: 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.
arm group label: Elite football players aged 16-40 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 16 Years
maximum age: 40 Years
last name: Richard Riley, PhD
role: Study Director
affiliation: Centre for Prognosis Research, Keele University. UK
last name: Jamie Sergeant, PhD
role: Study Director
affiliation: Arthritis Research UK Centre for Epidemiology, University of Manchester. UK.
last name: Michael Callaghan, PhD
role: Study Director
affiliation: Dept of Health Professions, Manchester Metropolitan University. UK
responsible party type: Principal Investigator
investigator affiliation: Manchester United Football Club
investigator full name: Tom Hughes
investigator title: Senior Physiotherapist and Clinical Lead
mesh term: Wounds and Injuries
mesh term: Sprains and Strains
sharing ipd: No
provided document: 