<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/NCT04456374</url>
  </required_header>
  <id_info>
    <org_study_id>YOUTH SOCCER STUDY-UTH-2020</org_study_id>
    <nct_id>NCT04456374</nct_id>
  </id_info>
  <brief_title>Performance Testing in Young Soccer Players</brief_title>
  <official_title>Evaluation of Soccer-specific Performance and Body Composition in Youth Soccer Players of Different Age Groups</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Thessaly</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Thessaly</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>
      The aim of this study is to investigate physiological characteristics, body composition and&#xD;
      performance indicators among youth soccer players of four age categories (U-12, U-14, U-16,&#xD;
      and U-18). Participants will undergo assessment of their body weight, body height and percent&#xD;
      of body fat as well as performance testing including flexibility, strength, vertical jump,&#xD;
      speed, repeated sprint ability, agility, dribbling and endurance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims at investigating anthropometric, body composition and performance indicators&#xD;
      among male youth soccer players. The study will be conducted prior to the preparation period.&#xD;
      Initially, participants and their parents (for those under 18 years) will be informed about&#xD;
      the benefits, risks and discomforts associated with the study and will provide a written&#xD;
      consent. Participants will be instructed to refrain from strenuous exercise for at least 48&#xD;
      hours prior to testing and they will be also asked to consume their normal diet. Prior to&#xD;
      testing all participants will be familiarized with testing procedures and specific test. Body&#xD;
      weight will be measured on a seca beam balance. Participants' height will be measured by&#xD;
      using a fixed stadiometer and the percent body fat will be calculated with bioelectrical&#xD;
      impedance analysis. Flexibility will be assessed by using the sit and reach test and the&#xD;
      lower body explosive strength will be determined through vertical jump testing (squat jump&#xD;
      and counter movement jump without arm swing). Knee flexor and extensor strength will be&#xD;
      assessed on an isokinetic dynamometer. Sprint performance will be assessed from a standing&#xD;
      start over by infrared photocells with participants running 10m and 30m as fast as they can.&#xD;
      The repeated sprint ability will be tested by using linear sprint test including 5 maximum&#xD;
      sprints of 30 meters with a 25-second recovery period in-between. Maximal oxygen consumption&#xD;
      (VO2max) will be determined by open-circuit spirometry via breath-by-breath analysis during a&#xD;
      graded exercise test to exhaustion on a treadmill. Furthermore, participants will be&#xD;
      evaluated in agility by using the short dribbling test and the ability to recover after&#xD;
      repeated intense exercise through the YO-YO Intermittent Recovery test 1 (only for u-16 and&#xD;
      U-18 groups).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 5, 2020</start_date>
  <completion_date type="Anticipated">September 10, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2020</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Flexibility</measure>
    <time_frame>At baseline</time_frame>
    <description>Flexibility will be assessed by using the sit-and-reach test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Jumping ability</measure>
    <time_frame>At baseline</time_frame>
    <description>Jumping ability will be assessed by measuring the vertical jumping performance using two different techniques: i) countermovement and ii) squat jump.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum speed</measure>
    <time_frame>At baseline</time_frame>
    <description>Maximum speed will be assessed over 10 m and 30 m by using light cells</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Repeated sprint ability</measure>
    <time_frame>At baseline</time_frame>
    <description>Repeated sprint ability will be assessed by performing five 30-m sprints with 25 seconds recovery period in-between, and using light cells.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Agility</measure>
    <time_frame>At baseline</time_frame>
    <description>The ability to change direction while dribbling the ball (termed agility) will be assessed by using the short dribbling test (performed according to standard procedures).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Endurance</measure>
    <time_frame>At baseline</time_frame>
    <description>Endurance will be assessed by using the Yo-Yo Intermittent Recovery test level 1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximal oxygen consumption (VO2max)</measure>
    <time_frame>At baseline</time_frame>
    <description>Maximal oxygen consumption will be measured by open-circuit spirometry via breath-by-breath analysis during a graded exercise test to exhaustion on a treadmill, using automated pulmonary gas exchange system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee flexor and extensor strength</measure>
    <time_frame>At baseline</time_frame>
    <description>Concentric and eccentric peak torque of knee flexors and extensors in both limbs (dominant and non-dominant) will be assessed on an isokinetic dynamometer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body height</measure>
    <time_frame>At baseline</time_frame>
    <description>Body height will be measured on a beam balance with stadiometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>At baseline</time_frame>
    <description>Body weight will be measured on a beam balance with stadiometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>At baseline</time_frame>
    <description>Body fat and fat-free mass will be estimated by using bioelectrical impedance.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Physical Performance</condition>
  <arm_group>
    <arm_group_label>Under-12 (U12) players</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Under-14 (U14) players</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Under-16 (U16) players</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Under-18 (U18) players</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Performance testing</intervention_name>
    <description>Soccer-specific performance will be evaluated by measuring flexibility, jumping ability, maximum speed, repeated spring ability, agility and endurance.</description>
    <arm_group_label>Under-12 (U12) players</arm_group_label>
    <arm_group_label>Under-14 (U14) players</arm_group_label>
    <arm_group_label>Under-16 (U16) players</arm_group_label>
    <arm_group_label>Under-18 (U18) players</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Youth soccer players (aged 11-18 years) participating in regular soccer practice and&#xD;
        competition with a training age of ≥ 3 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 11 and 12 years&#xD;
&#xD;
          -  Active soccer players participating in regular soccer practice and competition&#xD;
&#xD;
          -  Training age ≥ 3 years&#xD;
&#xD;
          -  Free of chronic diseases&#xD;
&#xD;
          -  Free of musculoskeletal injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Musculoskeletal injury&#xD;
&#xD;
          -  Chronic disease&#xD;
&#xD;
          -  Training age ≤ 2 years&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Athanasios Poulios, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Thessaly</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ioannis G Fatouros, Prof</last_name>
    <phone>+30 24310 47047</phone>
    <email>ifatouros@pe.uth.gr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Athanasios Z Jamurtas, Prof</last_name>
    <phone>+30 24310 47054</phone>
    <email>ajamurt@pe.uth.gr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Thessaly, School of Physical Education and Sports Science</name>
      <address>
        <city>Trikala</city>
        <zip>42100</zip>
        <country>Greece</country>
      </address>
    </facility>
    <contact>
      <last_name>Athanasios Z Jamurtas, Prof</last_name>
      <phone>+302431047054</phone>
      <email>ajamurt@pe.uth.gr</email>
    </contact>
    <contact_backup>
      <last_name>Ioannis G Fatouros, Prof</last_name>
      <phone>+302431047047</phone>
      <email>ifatouros@pe.uth.gr</email>
    </contact_backup>
    <investigator>
      <last_name>Athanasios Poulios, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 28, 2020</last_update_submitted>
  <last_update_submitted_qc>June 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Thessaly</investigator_affiliation>
    <investigator_full_name>Ioannis G. Fatouros</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>soccer</keyword>
  <keyword>performance</keyword>
  <keyword>youth</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04456374
org study id: YOUTH SOCCER STUDY-UTH-2020
nct id: NCT04456374
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate physiological characteristics, body composition and
      performance indicators among youth soccer players of four age categories (U-12, U-14, U-16,
      and U-18). Participants will undergo assessment of their body weight, body height and percent
      of body fat as well as performance testing including flexibility, strength, vertical jump,
      speed, repeated sprint ability, agility, dribbling and endurance.
This study aims at investigating anthropometric, body composition and performance indicators
      among male youth soccer players. The study will be conducted prior to the preparation period.
      Initially, participants and their parents (for those under 18 years) will be informed about
      the benefits, risks and discomforts associated with the study and will provide a written
      consent. Participants will be instructed to refrain from strenuous exercise for at least 48
      hours prior to testing and they will be also asked to consume their normal diet. Prior to
      testing all participants will be familiarized with testing procedures and specific test. Body
      weight will be measured on a seca beam balance. Participants' height will be measured by
      using a fixed stadiometer and the percent body fat will be calculated with bioelectrical
      impedance analysis. Flexibility will be assessed by using the sit and reach test and the
      lower body explosive strength will be determined through vertical jump testing (squat jump
      and counter movement jump without arm swing). Knee flexor and extensor strength will be
      assessed on an isokinetic dynamometer. Sprint performance will be assessed from a standing
      start over by infrared photocells with participants running 10m and 30m as fast as they can.
      The repeated sprint ability will be tested by using linear sprint test including 5 maximum
      sprints of 30 meters with a 25-second recovery period in-between. Maximal oxygen consumption
      (VO2max) will be determined by open-circuit spirometry via breath-by-breath analysis during a
      graded exercise test to exhaustion on a treadmill. Furthermore, participants will be
      evaluated in agility by using the short dribbling test and the ability to recover after
      repeated intense exercise through the YO-YO Intermittent Recovery test 1 (only for u-16 and
      U-18 groups).
observational model: Cohort
time perspective: Cross-Sectional
measure: Flexibility
time frame: At baseline
description: Flexibility will be assessed by using the sit-and-reach test
measure: Jumping ability
time frame: At baseline
description: Jumping ability will be assessed by measuring the vertical jumping performance using two different techniques: i) countermovement and ii) squat jump.
measure: Maximum speed
time frame: At baseline
description: Maximum speed will be assessed over 10 m and 30 m by using light cells
measure: Repeated sprint ability
time frame: At baseline
description: Repeated sprint ability will be assessed by performing five 30-m sprints with 25 seconds recovery period in-between, and using light cells.
measure: Agility
time frame: At baseline
description: The ability to change direction while dribbling the ball (termed agility) will be assessed by using the short dribbling test (performed according to standard procedures).
measure: Endurance
time frame: At baseline
description: Endurance will be assessed by using the Yo-Yo Intermittent Recovery test level 1
measure: Maximal oxygen consumption (VO2max)
time frame: At baseline
description: Maximal oxygen consumption will be measured by open-circuit spirometry via breath-by-breath analysis during a graded exercise test to exhaustion on a treadmill, using automated pulmonary gas exchange system.
measure: Knee flexor and extensor strength
time frame: At baseline
description: Concentric and eccentric peak torque of knee flexors and extensors in both limbs (dominant and non-dominant) will be assessed on an isokinetic dynamometer
measure: Body height
time frame: At baseline
description: Body height will be measured on a beam balance with stadiometer.
measure: Body weight
time frame: At baseline
description: Body weight will be measured on a beam balance with stadiometer.
measure: Body composition
time frame: At baseline
description: Body fat and fat-free mass will be estimated by using bioelectrical impedance.
arm group label: Under-12 (U12) players
arm group label: Under-14 (U14) players
arm group label: Under-16 (U16) players
arm group label: Under-18 (U18) players
intervention type: Other
intervention name: Performance testing
description: Soccer-specific performance will be evaluated by measuring flexibility, jumping ability, maximum speed, repeated spring ability, agility and endurance.
arm group label: Under-12 (U12) players
arm group label: Under-14 (U14) players
arm group label: Under-16 (U16) players
arm group label: Under-18 (U18) players
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
gender based: Yes
minimum age: 11 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Athanasios Poulios, PhD
role: Principal Investigator
affiliation: University of Thessaly
last name: Ioannis G Fatouros, Prof
phone: +30 24310 47047
email: ifatouros@pe.uth.gr
last name: Athanasios Z Jamurtas, Prof
phone: +30 24310 47054
email: ajamurt@pe.uth.gr
facility: 
contact: 
contact backup: 
investigator: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: University of Thessaly
investigator full name: Ioannis G. Fatouros
investigator title: Professor
sharing ipd: Undecided