xml: <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/NCT06001931</url>
    </required_header>
    <id_info>
      <org_study_id>IstanbulPMRTRHChldBioimpedans</org_study_id>
      <nct_id>NCT06001931</nct_id>
    </id_info>
    <brief_title>Determination of Reference Values for Handgrip Strength and Bioimpedance Values in Healthy Turkish Children</brief_title>
    <official_title>Reference Values for Handgrip Strength and Bioimpedance Values in Healthy Turkish Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</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>
        In this study, our aim is to determine the reference values for the handgrip force and&#xD;
        bioimpedance values in healthy Turkish children.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, our aim is to determine the reference values for the handgrip force and&#xD;
        bioimpedance values in healthy Turkish children.&#xD;
  &#xD;
        The study was planned as a cross-sectional clinical study. All healthy children studying at&#xD;
        Hamdi Akverdi Primary School and Halil Bedii Management Secondary School in the Bakırköy&#xD;
        region of Istanbul will be included. The date of birth of the children will be learned. It&#xD;
        will be determined in which city in Turkey the population is registered.&#xD;
  &#xD;
        TANITA BIA analysis and hand grip strength (with jamar) measured in the dominant hand were&#xD;
        planned for all children. In addition, the calf circumference of all children will be&#xD;
        measured. Written consent forms will be obtained from the families of the children before the&#xD;
        evaluation.&#xD;
  &#xD;
        It was planned to include 1500 children in the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>handgrip strength</measure>
      <time_frame>1 interview day</time_frame>
      <description>Handgrip strength will be measured using a Jamar hand grip dynamometer (Model 5030J1, Sammons Preston Rolyan, Bolingbrook, Illinois, USA). Measurements will be taken 3 times in a sitting position with the elbow flexed to 90° and the wrist in neutral position. The measured maximal grip strength will be recorded as hand grip strength.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>calf circumference</measure>
      <time_frame>1 interview day</time_frame>
      <description>Calf circumference is an anthropometric measurement that indicates fatfree muscle mass and has been considered by the World Health Organization (WHO) the most sensitive index for evaluating the decrease in muscle mass. Calf circumference will be measured with an elastic band over the subject's right leg, both sitting and standing.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body Mass Index (BMI)</measure>
      <time_frame>1 interview day</time_frame>
      <description>BMI will be calculated as weight (kg) divided by height2 (m2)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Skeletal muscle mass</measure>
      <time_frame>1 interview day</time_frame>
      <description>Skeletal muscle mass will be evaluated using a Tanita DC-360 multi-frequency body composition analysis device.</description>
    </primary_outcome>
    <enrollment type="Anticipated">800</enrollment>
    <condition>Sarcopenia</condition>
    <condition>Child Development</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>handgrip force and bioimpedance values in healthy Turkish children.</intervention_name>
      <description>Demographic characteristics, calf circumference , Hand grip strength , TANITA BIA analysis</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy Turkish children&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  healthy children&#xD;
  &#xD;
            -  Children under 18&#xD;
  &#xD;
            -  Turkish children&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children with malignancy or known chronic disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>TUGBA AYDIN</last_name>
      <role>Principal Investigator</role>
      <affiliation>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>TUGBA AYDIN, ASSOC.PROF</last_name>
      <phone>+905324622162</phone>
      <email>drtugbaaydin@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>TUGBA AYDIN, md</last_name>
      <phone>+905324622162</phone>
      <email>drtugbaaydin@gmail.com</email>
    </overall_contact_backup>
    <reference>
      <citation>Liu J, Yan Y, Xi B, Huang G, Mi J; China Child and Adolescent Cardiovascular Health (CCACH) Study Group. Skeletal muscle reference for Chinese children and adolescents. J Cachexia Sarcopenia Muscle. 2019 Feb;10(1):155-164. doi: 10.1002/jcsm.12361. Epub 2018 Nov 30.</citation>
      <PMID>30499245</PMID>
    </reference>
    <reference>
      <citation>McCarthy HD, Samani-Radia D, Jebb SA, Prentice AM. Skeletal muscle mass reference curves for children and adolescents. Pediatr Obes. 2014 Aug;9(4):249-59. doi: 10.1111/j.2047-6310.2013.00168.x. Epub 2013 Jun 18.</citation>
      <PMID>23776133</PMID>
    </reference>
    <reference>
      <citation>Rauch F, Neu CM, Wassmer G, Beck B, Rieger-Wettengl G, Rietschel E, Manz F, Schoenau E. Muscle analysis by measurement of maximal isometric grip force: new reference data and clinical applications in pediatrics. Pediatr Res. 2002 Apr;51(4):505-10. doi: 10.1203/00006450-200204000-00017.</citation>
      <PMID>11919337</PMID>
    </reference>
    <reference>
      <citation>Molenaar HM, Selles RW, Zuidam JM, Willemsen SP, Stam HJ, Hovius SE. Growth diagrams for grip strength in children. Clin Orthop Relat Res. 2010 Jan;468(1):217-23. doi: 10.1007/s11999-009-0881-z. Epub 2009 May 21.</citation>
      <PMID>19459024</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Tuğba Aydın</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>children</keyword>
    <keyword>muscle strength</keyword>
    <keyword>bioimpedance</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sarcopenia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06001931
  org study id: IstanbulPMRTRHChldBioimpedans
  nct id: NCT06001931
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this study, our aim is to determine the reference values for the handgrip force and
        bioimpedance values in healthy Turkish children.
  In this study, our aim is to determine the reference values for the handgrip force and
        bioimpedance values in healthy Turkish children.
  
        The study was planned as a cross-sectional clinical study. All healthy children studying at
        Hamdi Akverdi Primary School and Halil Bedii Management Secondary School in the Bakırköy
        region of Istanbul will be included. The date of birth of the children will be learned. It
        will be determined in which city in Turkey the population is registered.
  
        TANITA BIA analysis and hand grip strength (with jamar) measured in the dominant hand were
        planned for all children. In addition, the calf circumference of all children will be
        measured. Written consent forms will be obtained from the families of the children before the
        evaluation.
  
        It was planned to include 1500 children in the study.
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: handgrip strength
  time frame: 1 interview day
  description: Handgrip strength will be measured using a Jamar hand grip dynamometer (Model 5030J1, Sammons Preston Rolyan, Bolingbrook, Illinois, USA). Measurements will be taken 3 times in a sitting position with the elbow flexed to 90° and the wrist in neutral position. The measured maximal grip strength will be recorded as hand grip strength.
  measure: calf circumference
  time frame: 1 interview day
  description: Calf circumference is an anthropometric measurement that indicates fatfree muscle mass and has been considered by the World Health Organization (WHO) the most sensitive index for evaluating the decrease in muscle mass. Calf circumference will be measured with an elastic band over the subject's right leg, both sitting and standing.
  measure: Body Mass Index (BMI)
  time frame: 1 interview day
  description: BMI will be calculated as weight (kg) divided by height2 (m2)
  measure: Skeletal muscle mass
  time frame: 1 interview day
  description: Skeletal muscle mass will be evaluated using a Tanita DC-360 multi-frequency body composition analysis device.
  intervention type: Other
  intervention name: handgrip force and bioimpedance values in healthy Turkish children.
  description: Demographic characteristics, calf circumference , Hand grip strength , TANITA BIA analysis
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: TUGBA AYDIN
  role: Principal Investigator
  affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
  last name: TUGBA AYDIN, ASSOC.PROF
  phone: +905324622162
  email: drtugbaaydin@gmail.com
  last name: TUGBA AYDIN, md
  phone: +905324622162
  email: drtugbaaydin@gmail.com
  citation: Liu J, Yan Y, Xi B, Huang G, Mi J; China Child and Adolescent Cardiovascular Health (CCACH) Study Group. Skeletal muscle reference for Chinese children and adolescents. J Cachexia Sarcopenia Muscle. 2019 Feb;10(1):155-164. doi: 10.1002/jcsm.12361. Epub 2018 Nov 30.
  PMID: 30499245
  citation: McCarthy HD, Samani-Radia D, Jebb SA, Prentice AM. Skeletal muscle mass reference curves for children and adolescents. Pediatr Obes. 2014 Aug;9(4):249-59. doi: 10.1111/j.2047-6310.2013.00168.x. Epub 2013 Jun 18.
  PMID: 23776133
  citation: Rauch F, Neu CM, Wassmer G, Beck B, Rieger-Wettengl G, Rietschel E, Manz F, Schoenau E. Muscle analysis by measurement of maximal isometric grip force: new reference data and clinical applications in pediatrics. Pediatr Res. 2002 Apr;51(4):505-10. doi: 10.1203/00006450-200204000-00017.
  PMID: 11919337
  citation: Molenaar HM, Selles RW, Zuidam JM, Willemsen SP, Stam HJ, Hovius SE. Growth diagrams for grip strength in children. Clin Orthop Relat Res. 2010 Jan;468(1):217-23. doi: 10.1007/s11999-009-0881-z. Epub 2009 May 21.
  PMID: 19459024
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
  investigator full name: Tuğba Aydın
  investigator title: Principal Investigator
  mesh term: Sarcopenia
  sharing ipd: No