<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/NCT02977091</url>
  </required_header>
  <id_info>
    <org_study_id>0258-16-MMC</org_study_id>
    <nct_id>NCT02977091</nct_id>
  </id_info>
  <brief_title>Fitness Level in Short Stature Children and After Growth Hormone Treatment</brief_title>
  <official_title>Fitness Level in Short Stature Children and After Growth Hormone Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      fitness and Physical activity will be evaluate in short stature children, using the Euro&#xD;
      Fitness testing and the Wingate anaerobic test. the fitness level will be evaluate in healthy&#xD;
      short children and with growth hormone deficiency at base line and after 6 month .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Euro Fitness testing which is a series of field testing for children evaluating aerobic,&#xD;
      strength and flexibility and the Wingate anaerobic test which is a 30 seconds maximum&#xD;
      pedaling against resistance on bike for evaluating the anaerobic fitness.&#xD;
&#xD;
      the fitness test will be done in healthy short stature children and in growth hormone&#xD;
      deficiency or idiopathic short stature from the endocrine unit in Meir medical center The&#xD;
      test will be done at base line and after 6 month . The fitness test in child with growth&#xD;
      hormone deficiency will be done before starting GH treatment and 6 month later.&#xD;
&#xD;
      The child will be asked to fill a questioner about his daily physical activity Anthropometric&#xD;
      measurement will be taking including weight, height and fat percent. Details about age, sex,&#xD;
      tanner stage, indication for growth hormone, dose, insulin growth factor-1 (IGF1) level will&#xD;
      be taken from the medical file.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 15, 2016</start_date>
  <completion_date type="Anticipated">March 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>change in fitness level</measure>
    <time_frame>change of fitness levels from base line and after 6 month in short children</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Fitness</condition>
  <arm_group>
    <arm_group_label>GH deficiency or idiopathic short stature</arm_group_label>
    <description>growth hormone (GH) deficiency or idiopathic short stature children before they start GH treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>short stature</arm_group_label>
    <description>healthy short children</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>change in fitness level</intervention_name>
    <description>fitness level assessed by the Euro-fit tests for school age children.including 1.body fat 2. single leg balance test 3.Plate Tapping -for speed of limb movement 4.Sit-and-Reach flexibility test 5. Standing Broad Jump - measures explosive leg power. 6.Handgrip Test - measures static arm strength 7.Sit-Ups in 30 seconds - measures trunk strength 8.Bent Arm Hang - muscular endurance/functional strength 9.20 m endurance shuttle-run - cardiorespiratory endurance Wingate anaerobic test which is a 30 seconds maximum pedaling against resistance on bike for evaluating the anaerobic fitness</description>
    <arm_group_label>GH deficiency or idiopathic short stature</arm_group_label>
    <arm_group_label>short stature</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        short stature children&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  short stature&#xD;
&#xD;
          -  Physical healthy&#xD;
&#xD;
          -  Mental healthy&#xD;
&#xD;
          -  Capable to perform fitness test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac disease that interfere or risk the child during physical activity&#xD;
&#xD;
          -  Respiratory disease that interfere or risk the child during physical activity&#xD;
&#xD;
          -  Musculoskeletal disease interfering physical preformance.&#xD;
&#xD;
          -  Family history of death for unknown reasons at an early age.&#xD;
&#xD;
          -  Uncontroled thyroid diseae&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nitsan Dror, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>senior in pediatric medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nitsan Dror, MD</last_name>
    <phone>00972-9-7471910</phone>
    <email>nitzand@clalit.org.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michal Pantanowitz, PHD</last_name>
    <phone>00972-9-7471596</phone>
    <email>michalmirochnik@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Meir Medical Center endocrine unit</name>
      <address>
        <city>Kfar Saba</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nitsan Dror, MD</last_name>
      <phone>0097297471596</phone>
      <email>nitzand@clalit.org.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <link>
    <url>http://www.topendsports.com/testing/children.htm</url>
    <description>The Eurofit Physical Fitness Test Battery</description>
  </link>
  <reference>
    <citation>Bar-Or O. The Wingate anaerobic test. An update on methodology, reliability and validity. Sports Med. 1987 Nov-Dec;4(6):381-94. doi: 10.2165/00007256-198704060-00001. No abstract available.</citation>
    <PMID>3324256</PMID>
  </reference>
  <reference>
    <citation>Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.</citation>
    <PMID>4053261</PMID>
  </reference>
  <reference>
    <citation>Ranson R, Stratton G, Taylor SR. Digit ratio (2D:4D) and physical fitness (Eurofit test battery) in school children. Early Hum Dev. 2015 May;91(5):327-31. doi: 10.1016/j.earlhumdev.2015.03.005. Epub 2015 Apr 4.</citation>
    <PMID>25846842</PMID>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>October 3, 2018</last_update_submitted>
  <last_update_submitted_qc>October 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Meir Medical Center</investigator_affiliation>
    <investigator_full_name>Dror Nitsan</investigator_full_name>
    <investigator_title>M.D</investigator_title>
  </responsible_party>
  <keyword>short stature</keyword>
  <keyword>fitness</keyword>
  <keyword>children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dwarfism</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/NCT02977091
org study id: 0258-16-MMC
nct id: NCT02977091
lead sponsor: 
has dmc: No
fitness and Physical activity will be evaluate in short stature children, using the Euro
      Fitness testing and the Wingate anaerobic test. the fitness level will be evaluate in healthy
      short children and with growth hormone deficiency at base line and after 6 month .
The Euro Fitness testing which is a series of field testing for children evaluating aerobic,
      strength and flexibility and the Wingate anaerobic test which is a 30 seconds maximum
      pedaling against resistance on bike for evaluating the anaerobic fitness.

      the fitness test will be done in healthy short stature children and in growth hormone
      deficiency or idiopathic short stature from the endocrine unit in Meir medical center The
      test will be done at base line and after 6 month . The fitness test in child with growth
      hormone deficiency will be done before starting GH treatment and 6 month later.

      The child will be asked to fill a questioner about his daily physical activity Anthropometric
      measurement will be taking including weight, height and fat percent. Details about age, sex,
      tanner stage, indication for growth hormone, dose, insulin growth factor-1 (IGF1) level will
      be taken from the medical file.
observational model: Cohort
time perspective: Prospective
measure: change in fitness level
time frame: change of fitness levels from base line and after 6 month in short children
arm group label: GH deficiency or idiopathic short stature
description: growth hormone (GH) deficiency or idiopathic short stature children before they start GH treatment
arm group label: short stature
description: healthy short children
intervention type: Other
intervention name: change in fitness level
description: fitness level assessed by the Euro-fit tests for school age children.including 1.body fat 2. single leg balance test 3.Plate Tapping -for speed of limb movement 4.Sit-and-Reach flexibility test 5. Standing Broad Jump - measures explosive leg power. 6.Handgrip Test - measures static arm strength 7.Sit-Ups in 30 seconds - measures trunk strength 8.Bent Arm Hang - muscular endurance/functional strength 9.20 m endurance shuttle-run - cardiorespiratory endurance Wingate anaerobic test which is a 30 seconds maximum pedaling against resistance on bike for evaluating the anaerobic fitness
arm group label: GH deficiency or idiopathic short stature
arm group label: short stature
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nitsan Dror, MD
role: Principal Investigator
affiliation: senior in pediatric medicine
last name: Nitsan Dror, MD
phone: 00972-9-7471910
email: nitzand@clalit.org.il
last name: Michal Pantanowitz, PHD
phone: 00972-9-7471596
email: michalmirochnik@gmail.com
facility: 
status: Recruiting
contact: 
country: Israel
url: http://www.topendsports.com/testing/children.htm
description: The Eurofit Physical Fitness Test Battery
citation: Bar-Or O. The Wingate anaerobic test. An update on methodology, reliability and validity. Sports Med. 1987 Nov-Dec;4(6):381-94. doi: 10.2165/00007256-198704060-00001. No abstract available.
PMID: 3324256
citation: Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
PMID: 4053261
citation: Ranson R, Stratton G, Taylor SR. Digit ratio (2D:4D) and physical fitness (Eurofit test battery) in school children. Early Hum Dev. 2015 May;91(5):327-31. doi: 10.1016/j.earlhumdev.2015.03.005. Epub 2015 Apr 4.
PMID: 25846842
responsible party type: Principal Investigator
investigator affiliation: Meir Medical Center
investigator full name: Dror Nitsan
investigator title: M.D
mesh term: Dwarfism
sharing ipd: No