<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/NCT01692314</url>
  </required_header>
  <id_info>
    <org_study_id>BIOVASC 2009</org_study_id>
    <nct_id>NCT01692314</nct_id>
  </id_info>
  <brief_title>Effect of Resistance Training on Microvascular, Hemodynamic and Physical Parameters in Obese Adolescents</brief_title>
  <official_title>Effect of Resistance Training on Microvascular Reactivity, Endothelial Function, Inflammatory Markers, Body Composition, Blood Pressure, Heart Rate and Physical Fitness in Obese Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rio de Janeiro State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rio de Janeiro State Research Supporting Foundation (FAPERJ)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rio de Janeiro State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effect os resistance training on&#xD;
      microvascular reactivity, endothelial functions, inflammatory markers, blood pressure, heart&#xD;
      rate, body composition and physical fitness in obese adolescents.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2010</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">September 2010</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Microvascular Reactivity</measure>
    <time_frame>Three months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Endothelial function</measure>
    <time_frame>Three months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Hemodynamic parameters</measure>
    <time_frame>three months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Imflammatory markers</measure>
    <time_frame>three months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Body composition</measure>
    <time_frame>three months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Physical fitness</measure>
    <time_frame>three months</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Obese adolescents is being compared to control ones</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients underwent to resistance training, three times a week, during three months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resistance training</intervention_name>
    <arm_group_label>Obese adolescents is being compared to control ones</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Tanner pubertal stage of development between three and five&#xD;
&#xD;
          -  age between 13 up to 17 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of chronic diseases (diabetes mellitus, nephropathy and/or hypertension),&#xD;
&#xD;
          -  musculoskeletal injury,&#xD;
&#xD;
          -  smoking and&#xD;
&#xD;
          -  to be in use of any medication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eliete Bouskela, Phd</last_name>
    <role>Study Director</role>
    <affiliation>State University of Rio de Janeiro</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laboratory for Clinical and Experimental Research in Vascular Biology (BioVasc), Biomedical Center, State University of Rio de Janeiro</name>
      <address>
        <city>Rio de Janeiro</city>
        <state>RJ</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>September 24, 2012</last_update_submitted>
  <last_update_submitted_qc>September 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rio de Janeiro State University</investigator_affiliation>
    <investigator_full_name>Ingrid Barbara Ferreira Dias</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Endothelial function</keyword>
  <keyword>Microvascular reactivity</keyword>
  <keyword>Obesity</keyword>
  <keyword>Adolescents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <!-- 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/NCT01692314
org study id: BIOVASC 2009
nct id: NCT01692314
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to investigate the effect os resistance training on
      microvascular reactivity, endothelial functions, inflammatory markers, blood pressure, heart
      rate, body composition and physical fitness in obese adolescents.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Microvascular Reactivity
time frame: Three months
measure: Endothelial function
time frame: Three months
measure: Hemodynamic parameters
time frame: three months
measure: Imflammatory markers
time frame: three months
measure: Body composition
time frame: three months
measure: Physical fitness
time frame: three months
arm group label: Obese adolescents is being compared to control ones
arm group type: Experimental
description: Patients underwent to resistance training, three times a week, during three months.
intervention type: Other
intervention name: Resistance training
arm group label: Obese adolescents is being compared to control ones
criteria: 
gender: All
minimum age: 13 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eliete Bouskela, Phd
role: Study Director
affiliation: State University of Rio de Janeiro
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Rio de Janeiro State University
investigator full name: Ingrid Barbara Ferreira Dias
investigator title: Principal Investigator
mesh term: Obesity