<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/NCT01695785</url>
  </required_header>
  <id_info>
    <org_study_id>M12-079</org_study_id>
    <nct_id>NCT01695785</nct_id>
  </id_info>
  <brief_title>Perception of Physical Exertion in Healthy Weight and Obese Adolescents</brief_title>
  <official_title>Perception of Physical Exertion in Healthy Weight and Obese Adolescents: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Vermont</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Vermont</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Little is known regarding the relationship between perceived and physiological exertion in&#xD;
      adolescents. The purpose of this study is to investigate the association between&#xD;
      physiological and perceptual markers of effort during exercise and the relationship of these&#xD;
      markers to other health-related behaviors in healthy weight and obese adolescents.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>June 2012</start_date>
  <completion_date type="Anticipated">August 2016</completion_date>
  <primary_completion_date type="Anticipated">August 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Physiological responses to submaximal and maximal treadmill exercise</measure>
    <time_frame>7-10 days</time_frame>
    <description>Physiological responses to submaximal and maximal treadmill exercise will be assessed during the exercise test and immediately upon completion of the exercise test. The submaximal treadmill exercise will take place at visit 1 and the maximal treadmill exercise test will take place at the 2nd and final visit which will occur 7-10 days from the 1st visit. There is no intervention between visits.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perceptual responses to submaximal and maximal treadmill exercise</measure>
    <time_frame>7-10 days</time_frame>
    <description>Perceptual responses to submaximal and maximal treadmill exercise will be assessed during the exercise test and immediately upon completion of the exercise test. The submaximal treadmill exercise will take place at visit 1 and the maximal treadmill exercise test will take place at the 2nd and final visit which will occur 7-10 days from the 1st visit. There is no intervention between visits.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Physical activity intention</measure>
    <time_frame>7 days</time_frame>
    <description>Subjects will be asked how much physical activity they plan or intend to participate in for the next 7 days.</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical activity behavior</measure>
    <time_frame>7 days</time_frame>
    <description>Subjects will be asked how much physical activity they participated in for the past 7 days.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Physiological Response to Exercise</condition>
  <condition>Perception of Exercise Difficulty</condition>
  <arm_group>
    <arm_group_label>Healthy weight</arm_group_label>
    <description>greater than or equal to the 5th to less than the 85th BMI percentile</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese</arm_group_label>
    <description>greater than or equal to the 95th BMI percentile</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy weight and obese adolescents from the community&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy weight (&gt;5th-85th BMI percentile) or obese (&gt;95th BMI percentile)&#xD;
&#xD;
          -  male and female adolescents, 13-18 years&#xD;
&#xD;
          -  Approval to participate in a submaximal and maximal treadmill test received from the&#xD;
             adolescent's pediatrician.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Underweight (&lt;5th BMI percentile)&#xD;
&#xD;
          -  overweight (85 - &lt;95th BMI percentile)&#xD;
&#xD;
          -  evidence/reporting of significant cardiovascular disease, cardiac arrhythmias, liver&#xD;
             disease, or the chronic use of medications including diuretics, steroids and&#xD;
             adrenergic-stimulating agents.&#xD;
&#xD;
          -  Adolescents with emotional problems such as clinical depression or other diagnosed&#xD;
             psychological condition and currently use prescription medication for psychological&#xD;
             conditions.&#xD;
&#xD;
          -  Approval to participate in a submaximal and maximal treadmill test from the&#xD;
             adolescent's pediatrician not obtained&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Connie Tompkins, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Vermont</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Vermont</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>September 9, 2015</last_update_submitted>
  <last_update_submitted_qc>September 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Vermont</investigator_affiliation>
    <investigator_full_name>Connie Tompkins, PhD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT01695785
org study id: M12-079
nct id: NCT01695785
lead sponsor: 
has dmc: No
Little is known regarding the relationship between perceived and physiological exertion in
      adolescents. The purpose of this study is to investigate the association between
      physiological and perceptual markers of effort during exercise and the relationship of these
      markers to other health-related behaviors in healthy weight and obese adolescents.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Physiological responses to submaximal and maximal treadmill exercise
time frame: 7-10 days
description: Physiological responses to submaximal and maximal treadmill exercise will be assessed during the exercise test and immediately upon completion of the exercise test. The submaximal treadmill exercise will take place at visit 1 and the maximal treadmill exercise test will take place at the 2nd and final visit which will occur 7-10 days from the 1st visit. There is no intervention between visits.
measure: Perceptual responses to submaximal and maximal treadmill exercise
time frame: 7-10 days
description: Perceptual responses to submaximal and maximal treadmill exercise will be assessed during the exercise test and immediately upon completion of the exercise test. The submaximal treadmill exercise will take place at visit 1 and the maximal treadmill exercise test will take place at the 2nd and final visit which will occur 7-10 days from the 1st visit. There is no intervention between visits.
measure: Physical activity intention
time frame: 7 days
description: Subjects will be asked how much physical activity they plan or intend to participate in for the next 7 days.
measure: Physical activity behavior
time frame: 7 days
description: Subjects will be asked how much physical activity they participated in for the past 7 days.
arm group label: Healthy weight
description: greater than or equal to the 5th to less than the 85th BMI percentile
arm group label: Obese
description: greater than or equal to the 95th BMI percentile
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 13 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Connie Tompkins, PhD
role: Principal Investigator
affiliation: University of Vermont
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Vermont
investigator full name: Connie Tompkins, PhD
investigator title: Assistant Professor