<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/NCT03300895</url>
  </required_header>
  <id_info>
    <org_study_id>HIIT2-AFIS-UdeA</org_study_id>
    <nct_id>NCT03300895</nct_id>
  </id_info>
  <brief_title>High-intensity Interval Training on Cardiorespiratory Fitness in Overweight Women</brief_title>
  <official_title>Effect of Low-volume High-intensity Interval Training on Cardiorespiratory Fitness and Total Body Fat in Overweight Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Antioquia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Antioquia</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>
      High-intensity interval training (HIIT) is currently considered one of the most effective&#xD;
      strategies to improved cardiorespiratory fitness, which is recognized as a protective factor&#xD;
      for cardiovascular diseases and metabolic diseases such as overweight and obesity. However,&#xD;
      current evidence is still limited and requires clarity (frequency, time per session and&#xD;
      intensity) regarding to greater increases attributed to HIIT.&#xD;
&#xD;
      The aim of this study is to compare the effect of a low-volume high-intensity interval&#xD;
      training versus a moderate-intensity continuous exercise on maximal oxygen consumption in&#xD;
      overweight women 18 to 44 years old.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thirty-six women will be randomly assigned to one of two aerobic exercise on a real-life&#xD;
      setting supervised for a physical activity instructor. The interventions will performed three&#xD;
      times a week for ten-weeks (on alternate days).&#xD;
&#xD;
      The first two weeks will correspond to the conditioning period (30 minutes between 55-65% of&#xD;
      maximum heart rate (HRmax). From week three, 18 participants will perform 30 minutes of&#xD;
      continuous exercise at an intensity between 65-75 % of HRmax, and the remaining 18 will&#xD;
      complete 21.5 minutes of interval exercise at an intensity between 90-95% of HRmax, with&#xD;
      recoveries between 50-55% of HRmax.&#xD;
&#xD;
      All Participants will be evaluated to measure their maximal oxygen consumption, total body&#xD;
      fat, waist circumference, body mass index, systolic blood pressure, diastolic blood pressure,&#xD;
      prior to start the interventions and at the end of the program (week 11).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2017</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in maximal oxygen consumption</measure>
    <time_frame>Baseline and after 10 weeks</time_frame>
    <description>Maximal oxygen consumption will be obtained using a graded exercise test on a treadmill (Trackmaster® model TMX 425C) using a portable K4b2 gas analyzer (Cosmed Inc., IL, USA)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in total body fat</measure>
    <time_frame>Baseline and after 10 weeks</time_frame>
    <description>Total body fat will be obtained using an Omron® HBF-510 (Omron Healthcare, Inc. Bannockburn, IL, USA) bioelectrical impedance machine.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>High-intensity interval training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate-intensity continuous exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-intensity interval training</intervention_name>
    <description>21.5 minutes of high-intensity interval exercise at an intensity between 90-95 of HRmax (15x30 s), with recoveries at 50-60% of HRmax (14x60 s). 24 sessions, 3x weekly of walking and running outdoors on a sports field in a supervised manner.</description>
    <arm_group_label>High-intensity interval training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Comparator: Moderate-intensity continuous exercise</intervention_name>
    <description>30 minutes of continuous exercise at an intensity between 65-75% of HRmax. 24 sessions, 3x weekly of walking and jogging outdoors on a sports field in a supervised manner</description>
    <arm_group_label>Moderate-intensity continuous exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Overweight (≥ 25 kg/m-2) women 18 to 44 years.&#xD;
&#xD;
          -  Healthy volunteers.&#xD;
&#xD;
          -  Perform ≤ 600 Met/min/week.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Perform high-intensity interval exercise in the last six month.&#xD;
&#xD;
          -  Smoker.&#xD;
&#xD;
          -  History of asthma.&#xD;
&#xD;
          -  History of diabetes.&#xD;
&#xD;
          -  History of hypertension.&#xD;
&#xD;
          -  History of cardiovascular disease.&#xD;
&#xD;
          -  History of coronary heart disease.&#xD;
&#xD;
          -  Arrhythmias.&#xD;
&#xD;
          -  Personal history of surgical procedures in the last three months&#xD;
&#xD;
          -  Uncontrolled non-communicable diseases&#xD;
&#xD;
          -  Under medical treatment with anticoagulants, beta-blockers, calcium antagonists,&#xD;
             bronchodilators, and/or steroids.&#xD;
&#xD;
          -  Psychological, neuromotor and/or osteo-muscular conditions that may affect&#xD;
             participation in an exercise program.&#xD;
&#xD;
          -  Psychoactive drug abuse.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidad de Antioquia</name>
      <address>
        <city>Medellín</city>
        <state>Antioquia</state>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Antioquia</investigator_affiliation>
    <investigator_full_name>Victor Hugo Arboleda Serna</investigator_full_name>
    <investigator_title>PhD, MSc</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</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/NCT03300895
org study id: HIIT2-AFIS-UdeA
nct id: NCT03300895
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
High-intensity interval training (HIIT) is currently considered one of the most effective
      strategies to improved cardiorespiratory fitness, which is recognized as a protective factor
      for cardiovascular diseases and metabolic diseases such as overweight and obesity. However,
      current evidence is still limited and requires clarity (frequency, time per session and
      intensity) regarding to greater increases attributed to HIIT.

      The aim of this study is to compare the effect of a low-volume high-intensity interval
      training versus a moderate-intensity continuous exercise on maximal oxygen consumption in
      overweight women 18 to 44 years old.
Thirty-six women will be randomly assigned to one of two aerobic exercise on a real-life
      setting supervised for a physical activity instructor. The interventions will performed three
      times a week for ten-weeks (on alternate days).

      The first two weeks will correspond to the conditioning period (30 minutes between 55-65% of
      maximum heart rate (HRmax). From week three, 18 participants will perform 30 minutes of
      continuous exercise at an intensity between 65-75 % of HRmax, and the remaining 18 will
      complete 21.5 minutes of interval exercise at an intensity between 90-95% of HRmax, with
      recoveries between 50-55% of HRmax.

      All Participants will be evaluated to measure their maximal oxygen consumption, total body
      fat, waist circumference, body mass index, systolic blood pressure, diastolic blood pressure,
      prior to start the interventions and at the end of the program (week 11).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in maximal oxygen consumption
time frame: Baseline and after 10 weeks
description: Maximal oxygen consumption will be obtained using a graded exercise test on a treadmill (Trackmaster® model TMX 425C) using a portable K4b2 gas analyzer (Cosmed Inc., IL, USA)
measure: Change in total body fat
time frame: Baseline and after 10 weeks
description: Total body fat will be obtained using an Omron® HBF-510 (Omron Healthcare, Inc. Bannockburn, IL, USA) bioelectrical impedance machine.
arm group label: High-intensity interval training
arm group type: Experimental
arm group label: Moderate-intensity continuous exercise
arm group type: Active Comparator
intervention type: Other
intervention name: High-intensity interval training
description: 21.5 minutes of high-intensity interval exercise at an intensity between 90-95 of HRmax (15x30 s), with recoveries at 50-60% of HRmax (14x60 s). 24 sessions, 3x weekly of walking and running outdoors on a sports field in a supervised manner.
arm group label: High-intensity interval training
intervention type: Other
intervention name: Comparator: Moderate-intensity continuous exercise
description: 30 minutes of continuous exercise at an intensity between 65-75% of HRmax. 24 sessions, 3x weekly of walking and jogging outdoors on a sports field in a supervised manner
arm group label: Moderate-intensity continuous exercise
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Colombia
responsible party type: Principal Investigator
investigator affiliation: Universidad de Antioquia
investigator full name: Victor Hugo Arboleda Serna
investigator title: PhD, MSc
mesh term: Overweight
sharing ipd: No