<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/NCT03000140</url>
  </required_header>
  <id_info>
    <org_study_id>Number 03052015</org_study_id>
    <nct_id>NCT03000140</nct_id>
  </id_info>
  <brief_title>High-Intensity Interval Training on Pre-Hypertensive Subjects</brief_title>
  <official_title>Health Status Factors Predicting Responses to Long-Term Training: Effects of 16-Week High-Intensity Interval Training on Pre-Hypertensive Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Santo Tomas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Healthcare Center Tomas Rojas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Los Ríos</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidad Pública de Navarra</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidad del Rosario</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad Santo Tomas</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite exercise training decrease blood pressure in 'average' terms, there is a wide&#xD;
      interindividual variability after exercise training, being yet unknown what mode of exercise&#xD;
      (e.g. endurance, strength, concurrent, or high intensity interval training) produce more/less&#xD;
      non-responder (NR) prevalence (i.e., percentage of subjects who experienced a&#xD;
      non-change/worsened response after training in some outcome).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite exercise training decrease blood pressure in 'average' terms, there is a wide&#xD;
      interindividual variability after exercise training, being yet unknown what mode of exercise&#xD;
      (e.g. endurance, strength, concurrent, or high intensity interval training) produce more/less&#xD;
      non-responder (NR) prevalence (i.e., percentage of subjects who experienced a&#xD;
      non-change/worsened response after training in some outcome).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in systolic blood pressure and diastolic blood pressure</measure>
    <time_frame>Baseline and 16 weeks immediately after the interventions ends</time_frame>
    <description>After this, we calculated the delta changes in both variables and classified to all subjects in responders (R) and non-responders (NR) to decrease systolic or diastolic blood pressure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in body mass</measure>
    <time_frame>Baseline and 16 weeks immediately after the interventions ends</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in body mass index</measure>
    <time_frame>Baseline and 16 weeks immediately after the interventions ends</time_frame>
    <description>BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in waist circumference</measure>
    <time_frame>Baseline and 16 weeks immediately after the interventions ends</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in fat mass</measure>
    <time_frame>Baseline and 16 weeks immediately after the interventions ends</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in heart rate at rest</measure>
    <time_frame>Baseline and 16 weeks immediately after the interventions ends</time_frame>
    <description>Baseline and 16 weeks immediately after the interventions ends</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in fasting glucose</measure>
    <time_frame>Baseline and 16 weeks immediately after the interventions ends</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in lipids</measure>
    <time_frame>Baseline and 16 weeks immediately after the interventions ends</time_frame>
    <description>Lipid profile (low-density cholesterol, total cholesterol, high-density cholesterol and triglycerides)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in one maximum repetition strength test of leg-extension exercise</measure>
    <time_frame>Baseline and 16 weeks immediately after the interventions ends</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">142</enrollment>
  <condition>Metabolism Disorder</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>High Intensity Interval Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cycling on cycle ergometers (OXFORDTM, model BE2601, OXOFORD Inc, Santiago, Chile) for 1 min at a subjective intensity of 8-10 points of the modified Borg scale of 1-10 points, and interspersed by inactive (without movement over the bicycle) of 2 minutes as recovery period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pre-hypertensive group was compared with healthy groups in the 2 manin variables systolic/diastolic blood pressure, as well as in other co-variables in pre-post changes. Thus, after the training intervention, and following the R and NR classification, we will compare the NR prevalence between both Pre-hypertensive and Healthy group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High Intensity Interval Training</intervention_name>
    <description>High Intensity Interval Training pre-hypertensive group; Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 16 weeks.</description>
    <arm_group_label>High Intensity Interval Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>Moderade Intensity Interval Training pre-hypertensive group; Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 16 weeks.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent;&#xD;
&#xD;
          -  Interested in improving health and fitness;&#xD;
&#xD;
          -  Systolic blood pressure &gt; 120 mmHg and &lt; 140 mmHg, and/or DBP ≥ 80 and &lt; 90 mmHg&#xD;
             according with standard classification;&#xD;
&#xD;
          -  No drug therapy during the previous 3 months;&#xD;
&#xD;
          -  Body mass index (BMI) 25 and 35 kg/m2); (c) physically inactive (according to the&#xD;
             International Physical Activity Questionnaire previously validated in Chilean&#xD;
             population)&#xD;
&#xD;
          -  Normal /mild altered lipid profile (total cholesterol [TC] ~200 and ≤250 mg/dL,&#xD;
             low-density lipids [LDL-C] ~140 mg/dL and ≤200 mg/dL, high-density lipids [HDL-C] ≥20&#xD;
             and ~40 mg/dL, triglycerides ~150 and ≤250 mg/dL) according with standard&#xD;
             classification.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiovascular contraindications to exercise histories of stroke;&#xD;
&#xD;
          -  Asthma and chronic obstructive pulmonary disease;&#xD;
&#xD;
          -  Musculoskeletal disorder such as low back pain;&#xD;
&#xD;
          -  Smokers in the last 3 months were not included in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cristian Alvarez</name>
      <address>
        <city>Osorno</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>December 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>October 10, 2018</last_update_submitted>
  <last_update_submitted_qc>October 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Diseases</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/NCT03000140
org study id: Number 03052015
nct id: NCT03000140
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Despite exercise training decrease blood pressure in 'average' terms, there is a wide
      interindividual variability after exercise training, being yet unknown what mode of exercise
      (e.g. endurance, strength, concurrent, or high intensity interval training) produce more/less
      non-responder (NR) prevalence (i.e., percentage of subjects who experienced a
      non-change/worsened response after training in some outcome).
Despite exercise training decrease blood pressure in 'average' terms, there is a wide
      interindividual variability after exercise training, being yet unknown what mode of exercise
      (e.g. endurance, strength, concurrent, or high intensity interval training) produce more/less
      non-responder (NR) prevalence (i.e., percentage of subjects who experienced a
      non-change/worsened response after training in some outcome).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Change from Baseline in systolic blood pressure and diastolic blood pressure
time frame: Baseline and 16 weeks immediately after the interventions ends
description: After this, we calculated the delta changes in both variables and classified to all subjects in responders (R) and non-responders (NR) to decrease systolic or diastolic blood pressure.
measure: Change from Baseline in body mass
time frame: Baseline and 16 weeks immediately after the interventions ends
measure: Change from Baseline in body mass index
time frame: Baseline and 16 weeks immediately after the interventions ends
description: BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.
measure: Change from Baseline in waist circumference
time frame: Baseline and 16 weeks immediately after the interventions ends
measure: Change from Baseline in fat mass
time frame: Baseline and 16 weeks immediately after the interventions ends
measure: Change from Baseline in heart rate at rest
time frame: Baseline and 16 weeks immediately after the interventions ends
description: Baseline and 16 weeks immediately after the interventions ends
measure: Change from Baseline in fasting glucose
time frame: Baseline and 16 weeks immediately after the interventions ends
measure: Change from Baseline in lipids
time frame: Baseline and 16 weeks immediately after the interventions ends
description: Lipid profile (low-density cholesterol, total cholesterol, high-density cholesterol and triglycerides)
measure: Change from Baseline in one maximum repetition strength test of leg-extension exercise
time frame: Baseline and 16 weeks immediately after the interventions ends
arm group label: High Intensity Interval Training
arm group type: Experimental
description: Cycling on cycle ergometers (OXFORDTM, model BE2601, OXOFORD Inc, Santiago, Chile) for 1 min at a subjective intensity of 8-10 points of the modified Borg scale of 1-10 points, and interspersed by inactive (without movement over the bicycle) of 2 minutes as recovery period.
arm group label: Control group
arm group type: Active Comparator
description: Pre-hypertensive group was compared with healthy groups in the 2 manin variables systolic/diastolic blood pressure, as well as in other co-variables in pre-post changes. Thus, after the training intervention, and following the R and NR classification, we will compare the NR prevalence between both Pre-hypertensive and Healthy group.
intervention type: Behavioral
intervention name: High Intensity Interval Training
description: High Intensity Interval Training pre-hypertensive group; Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 16 weeks.
arm group label: High Intensity Interval Training
intervention type: Behavioral
intervention name: Control group
description: Moderade Intensity Interval Training pre-hypertensive group; Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 16 weeks.
arm group label: Control group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Chile
responsible party type: Sponsor
mesh term: Metabolic Diseases