<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/NCT03770507</url>
  </required_header>
  <id_info>
    <org_study_id>2015-2467</org_study_id>
    <nct_id>NCT03770507</nct_id>
  </id_info>
  <brief_title>Gas Exchange Kinetics and Work Load During Exercise</brief_title>
  <official_title>Gas Exchange Kinetics and Work Load During Different Exercise Protocols in Healthy Children and Young Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Irvine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to understand how different kinds of exercise affect&#xD;
      the human body and the health of the heart and lungs. For example, some people like to&#xD;
      exercise continuously for relatively long periods of time while others like to exercise for&#xD;
      short periods of time with rest periods in between. Children tend to exercise in frequent&#xD;
      bouts of brief exercise interspersed with periods of rest. Also, some people like running or&#xD;
      treadmill exercise while others like to work out on stationary bicycles. To date, standard&#xD;
      exercise testing is based on a century-old paradigm used predominantly for adults that&#xD;
      involves maximal exercise protocols (cardiopulmonary exercise testing-CPET). Moreover,&#xD;
      different but widely used exercise modalities such as cycle ergometer and treadmills are&#xD;
      currently impossible to compare in children, and this has limited the clinical and research&#xD;
      application of such testing in the pediatric age-range. A major premise of this laboratory is&#xD;
      that laboratory testing of cardiopulmonary fitness in children should be based on protocols&#xD;
      that mimic naturally occurring patterns of exercise in children, rather than those that have&#xD;
      been artificially employed to assess maximal efforts in adults. This research project&#xD;
      designed to begin the process of systematically identifying protocols can be best used for&#xD;
      children and young adults. Participants will exercise in different protocols on a bicycle&#xD;
      ergometer or treadmill. This research could lead to improved and more accurate fitness&#xD;
      assessment and pave the way to an improved personalized exercise program in health and&#xD;
      illness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Nonapplicable clinical trial&#xD;
  </why_stopped>
  <start_date type="Actual">April 25, 2016</start_date>
  <completion_date type="Actual">April 25, 2016</completion_date>
  <primary_completion_date type="Actual">April 25, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Oxygen Uptake (VO2) measurements during exercise</measure>
    <time_frame>4 weeks</time_frame>
    <description>Breath by breath gas exchange VO2 in response to exercise.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Carbon Dioxide Production (VCO2) measurements during exercise</measure>
    <time_frame>4 weeks</time_frame>
    <description>Breath by breath gas exchange VCO2 in response to exercise</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Minute Ventilation (VE) measurements during exercise</measure>
    <time_frame>4 weeks</time_frame>
    <description>Breath by breath gas exchange Minute ventilation (VE) in response to exercise</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate (HR) measurements during exercise</measure>
    <time_frame>4 weeks</time_frame>
    <description>Breath by breath gas exchange HR values in response to exercise</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical fitness evaluation</measure>
    <time_frame>4 weeks</time_frame>
    <description>Physical activity questionnaire - Points are given to each level of activity, the mean of these points are taken which will give a physical activity summary score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leisure time evaluation</measure>
    <time_frame>4 weeks</time_frame>
    <description>Godin Leisure Time Exercise questionnaire - Total score will be measured Godin Leisure Time Exercise questionnaire - Total leisure activity score is calculated from points given to each level of activity from light to strenuous</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lean body mass measurements by Dial X-Ray Absorbiometry (DXA)</measure>
    <time_frame>4 weeks</time_frame>
    <description>lean body mass in kg's</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat percentage measurements by Dial X-Ray Absorbiometry (DXA)</measure>
    <time_frame>4 weeks</time_frame>
    <description>percent of fat tissue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat free mass measurements by Dial X-Ray Absorbiometry (DXA)</measure>
    <time_frame>4 weeks</time_frame>
    <description>fat free mass in kg's</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone mass measurements by Dial X-Ray Absorbiometry (DXA)</measure>
    <time_frame>4 weeks</time_frame>
    <description>bone mass in kg's</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle mass measurements</measure>
    <time_frame>4 weeks</time_frame>
    <description>Muscle mass in kg's will be determined by ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Puberty status measurements by using a growth and development questionnaire</measure>
    <time_frame>4 weeks</time_frame>
    <description>Children will fill a standard Tanner Staging questionnaire. The Tanner staging defines the physical characteristics of individuals. A Tanner stage status assigned to each child depending on their primary and secondary sexual development characteristics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of tissue oxygenation</measure>
    <time_frame>4 weeks</time_frame>
    <description>Concentration of oxy- and de-oxyhemoglobin will be measured non-invasively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurements of breath rate</measure>
    <time_frame>4 weeks</time_frame>
    <description>Respiratory sensors will be used to evaluate breath rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurements of lung volume</measure>
    <time_frame>4 weeks</time_frame>
    <description>Spirometry will be used to evaluate lung volume</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Methods of Exercise in Children</condition>
  <arm_group>
    <arm_group_label>Treadmill Exercise in Adolescents and Adults</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Comparison of gas exchange kinetics between treadmill and cyclo ergometer exercises</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cyclo Ergometer Exercise in Adolescents and Adults</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Comparison of gas exchange kinetics between treadmill and cyclo ergometer exercises</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise Training</intervention_name>
    <description>Comparison of stationary bike and treadmill exercise among adolescents and adults</description>
    <arm_group_label>Cyclo Ergometer Exercise in Adolescents and Adults</arm_group_label>
    <arm_group_label>Treadmill Exercise in Adolescents and Adults</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between the ages of 7-35 years old without any known respiratory, cardiac or metabolic&#xD;
             disease&#xD;
&#xD;
          -  Determined to be in good health by preparticipation history&#xD;
&#xD;
          -  No evidence of disease or disability that would impair participation in an exercise&#xD;
             testing&#xD;
&#xD;
          -  No chronic prescribed medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other limitation which in the eyes of the physician that would preclude ability to&#xD;
             perform exercise testing&#xD;
&#xD;
          -  Use of illegal drugs or abuse of alcohol&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pediatric Exercise and Genomics Research Center, University of California, Irvine</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697/92617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>November 8, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>February 9, 2021</last_update_submitted>
  <last_update_submitted_qc>February 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03770507/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03770507
org study id: 2015-2467
nct id: NCT03770507
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to understand how different kinds of exercise affect
      the human body and the health of the heart and lungs. For example, some people like to
      exercise continuously for relatively long periods of time while others like to exercise for
      short periods of time with rest periods in between. Children tend to exercise in frequent
      bouts of brief exercise interspersed with periods of rest. Also, some people like running or
      treadmill exercise while others like to work out on stationary bicycles. To date, standard
      exercise testing is based on a century-old paradigm used predominantly for adults that
      involves maximal exercise protocols (cardiopulmonary exercise testing-CPET). Moreover,
      different but widely used exercise modalities such as cycle ergometer and treadmills are
      currently impossible to compare in children, and this has limited the clinical and research
      application of such testing in the pediatric age-range. A major premise of this laboratory is
      that laboratory testing of cardiopulmonary fitness in children should be based on protocols
      that mimic naturally occurring patterns of exercise in children, rather than those that have
      been artificially employed to assess maximal efforts in adults. This research project
      designed to begin the process of systematically identifying protocols can be best used for
      children and young adults. Participants will exercise in different protocols on a bicycle
      ergometer or treadmill. This research could lead to improved and more accurate fitness
      assessment and pave the way to an improved personalized exercise program in health and
      illness.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Maximum Oxygen Uptake (VO2) measurements during exercise
time frame: 4 weeks
description: Breath by breath gas exchange VO2 in response to exercise.
measure: Carbon Dioxide Production (VCO2) measurements during exercise
time frame: 4 weeks
description: Breath by breath gas exchange VCO2 in response to exercise
measure: Minute Ventilation (VE) measurements during exercise
time frame: 4 weeks
description: Breath by breath gas exchange Minute ventilation (VE) in response to exercise
measure: Heart Rate (HR) measurements during exercise
time frame: 4 weeks
description: Breath by breath gas exchange HR values in response to exercise
measure: Physical fitness evaluation
time frame: 4 weeks
description: Physical activity questionnaire - Points are given to each level of activity, the mean of these points are taken which will give a physical activity summary score
measure: Leisure time evaluation
time frame: 4 weeks
description: Godin Leisure Time Exercise questionnaire - Total score will be measured Godin Leisure Time Exercise questionnaire - Total leisure activity score is calculated from points given to each level of activity from light to strenuous
measure: Lean body mass measurements by Dial X-Ray Absorbiometry (DXA)
time frame: 4 weeks
description: lean body mass in kg's
measure: Fat percentage measurements by Dial X-Ray Absorbiometry (DXA)
time frame: 4 weeks
description: percent of fat tissue
measure: Fat free mass measurements by Dial X-Ray Absorbiometry (DXA)
time frame: 4 weeks
description: fat free mass in kg's
measure: Bone mass measurements by Dial X-Ray Absorbiometry (DXA)
time frame: 4 weeks
description: bone mass in kg's
measure: Muscle mass measurements
time frame: 4 weeks
description: Muscle mass in kg's will be determined by ultrasound
measure: Puberty status measurements by using a growth and development questionnaire
time frame: 4 weeks
description: Children will fill a standard Tanner Staging questionnaire. The Tanner staging defines the physical characteristics of individuals. A Tanner stage status assigned to each child depending on their primary and secondary sexual development characteristics.
measure: Measurement of tissue oxygenation
time frame: 4 weeks
description: Concentration of oxy- and de-oxyhemoglobin will be measured non-invasively
measure: Measurements of breath rate
time frame: 4 weeks
description: Respiratory sensors will be used to evaluate breath rate
measure: Measurements of lung volume
time frame: 4 weeks
description: Spirometry will be used to evaluate lung volume
arm group label: Treadmill Exercise in Adolescents and Adults
arm group type: Experimental
description: Comparison of gas exchange kinetics between treadmill and cyclo ergometer exercises
arm group label: Cyclo Ergometer Exercise in Adolescents and Adults
arm group type: Experimental
description: Comparison of gas exchange kinetics between treadmill and cyclo ergometer exercises
intervention type: Other
intervention name: Exercise Training
description: Comparison of stationary bike and treadmill exercise among adolescents and adults
arm group label: Cyclo Ergometer Exercise in Adolescents and Adults
arm group label: Treadmill Exercise in Adolescents and Adults
criteria: 
gender: All
minimum age: 7 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
provided document: 