<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/NCT04495595</url>
  </required_header>
  <id_info>
    <org_study_id>CE061921</org_study_id>
    <nct_id>NCT04495595</nct_id>
  </id_info>
  <brief_title>Influence of the Biological Maturation on the Antrhopometric Variables and Sport Performance in Volleyball Players</brief_title>
  <official_title>Influence of the Biological Maturation on the Antrhopometric Variables and Sport Performance in Volleyball Players</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Católica San Antonio de Murcia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Católica San Antonio de Murcia</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 project consists of a cross-sectional study in which anthropometric variables, general&#xD;
      and specific performance variables of volleyball will be measured, and the biological&#xD;
      maturity stage will be calculated. The main objective is to establish a relationship between&#xD;
      the biological maturation state, the anthropometric characteristics and the performance in&#xD;
      physical fitness tests in volleyball players between 12 and 15 years of age. To do this,&#xD;
      there will be all the clubs in the Region of Murcia that have federated teams in these&#xD;
      categories.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 13, 2020</start_date>
  <completion_date type="Actual">March 4, 2021</completion_date>
  <primary_completion_date type="Actual">March 4, 2021</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>Volleyball performance</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Qualitative assessement of the individual sport performance, taking on account the team position on the league and the role of the player in the team. The instrument used to assess this variable will be a questionnaire and the result will be expressed in points (1 to 5 points).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biological maturation</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Calculated with anthropometric variables. The result obtained indicates the time left to the growth peak or the time that has passed from the growth peak</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle mass</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Muscle mass will be assessed with the corresponding formulas. The result will be expressed in kilograms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fat mass</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Fat mass will be assessed with the corresponding formulas. The result will be expressed in kilograms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bone mass</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Bone mass will be assessed with the corresponding formulas. The result will be expressed in kilograms.</description>
  </primary_outcome>
  <enrollment type="Actual">213</enrollment>
  <condition>Development, Adolescent</condition>
  <condition>Body Weight Changes</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>There is no intervention due to the observational, cross-sectional design of the study</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The sample objetive of the present study are all the volleyball players of Región of&#xD;
        Murcia, Spain, that meet the inclusion criteria and voluntarily decide to take part in the&#xD;
        study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To play volleyball in a regular basis&#xD;
&#xD;
          -  To have between 12 and 15 years&#xD;
&#xD;
          -  To participate in volleiball competitions with the team&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To be injured in the moment of the measurement session&#xD;
&#xD;
          -  To have skipped most of the training sessions the last month&#xD;
&#xD;
          -  To have less than a year of experience playing volleyball&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidad Católica San Antonio</name>
      <address>
        <city>Murcia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Católica San Antonio de Murcia</investigator_affiliation>
    <investigator_full_name>Mario Albaladejo-Saura</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Sport performance</keyword>
  <keyword>Volleyball</keyword>
  <keyword>Anthropometry</keyword>
  <keyword>Biological maturation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Body Weight Changes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04495595
org study id: CE061921
nct id: NCT04495595
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The project consists of a cross-sectional study in which anthropometric variables, general
      and specific performance variables of volleyball will be measured, and the biological
      maturity stage will be calculated. The main objective is to establish a relationship between
      the biological maturation state, the anthropometric characteristics and the performance in
      physical fitness tests in volleyball players between 12 and 15 years of age. To do this,
      there will be all the clubs in the Region of Murcia that have federated teams in these
      categories.
observational model: Cohort
time perspective: Cross-Sectional
measure: Volleyball performance
time frame: through study completion, an average of 1 year
description: Qualitative assessement of the individual sport performance, taking on account the team position on the league and the role of the player in the team. The instrument used to assess this variable will be a questionnaire and the result will be expressed in points (1 to 5 points).
measure: Biological maturation
time frame: through study completion, an average of 1 year
description: Calculated with anthropometric variables. The result obtained indicates the time left to the growth peak or the time that has passed from the growth peak
measure: Muscle mass
time frame: through study completion, an average of 1 year
description: Muscle mass will be assessed with the corresponding formulas. The result will be expressed in kilograms
measure: Fat mass
time frame: through study completion, an average of 1 year
description: Fat mass will be assessed with the corresponding formulas. The result will be expressed in kilograms
measure: Bone mass
time frame: through study completion, an average of 1 year
description: Bone mass will be assessed with the corresponding formulas. The result will be expressed in kilograms.
intervention type: Other
intervention name: No intervention
description: There is no intervention due to the observational, cross-sectional design of the study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Católica San Antonio de Murcia
investigator full name: Mario Albaladejo-Saura
investigator title: Principal Investigator
mesh term: Body Weight
mesh term: Body Weight Changes
sharing ipd: No