<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/NCT03236285</url>
  </required_header>
  <id_info>
    <org_study_id>CAAE:69240017.1.0000.5272</org_study_id>
    <nct_id>NCT03236285</nct_id>
  </id_info>
  <brief_title>Microvascular and Metabolic Effects of High-intensity Interval Exercise Training</brief_title>
  <acronym>HIIT-FAST</acronym>
  <official_title>Microvascular and Metabolic Effects of High-intensity Interval Training (HIIT) and Intermittent Fasting (FAST) in Overweight or Obese, Sedentary Women With Cardiometabolic Risk Factors: HIIT-FAST, a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Cardiology, Laranjeiras, Brazil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Cardiology, Laranjeiras, Brazil</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>
      The study investigates the effects of high intensity interval training (HIIT) versus&#xD;
      continuous training (CT), combined or not with fasting, on capillary density, microvascular&#xD;
      function, cardiometabolic risk markers, functional capacity, and quality of life, in&#xD;
      overweight or obese sedentary women with cardiometabolic risk factors. The use of HIIT could&#xD;
      promote greater improvements in these parameters than CT. Furthermore, the positive effects&#xD;
      of exercise may increase when it is performed in the fasting state, compared to exercise&#xD;
      performed in the fed state.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Physical inactivity and increased caloric intake play important roles in the pathophysiology&#xD;
      of obesity. Increases of physical activity and modifications of eating behaviors are&#xD;
      first-line interventions which, however, are not easily implemented, and lack of time to&#xD;
      exercise and difficulties in coping with different diets are common reasons for failure.&#xD;
      High-intensity interval training (HIIT) is a &quot;faster&quot; alternative to moderate-intensity&#xD;
      continuous training (CT). Conversely, intermittent fasting is also an alternative to more&#xD;
      complex diets, as it restricts caloric intake to a specified period of time without major&#xD;
      diet composition changes. The combination of HIIT and fasting may therefore provide&#xD;
      incremental benefits.&#xD;
&#xD;
      Sedentary women aged ≥ 30 years and ≤50 years, with body mass index ≥25 kg/m2 and&#xD;
      cardiometabolic risk factors, will be randomized to HIIT performed in the fasting state, HIIT&#xD;
      performed in the fed state, CT in the fasting state or CT in the fed state. Cardiometabolic&#xD;
      parameters, anthropometric indices, cardiorespiratory fitness, quality of life and&#xD;
      microvascular function (cutaneous capillary density and microvascular reactivity evaluated by&#xD;
      laser speckle contrast imaging) will be evaluated before the initiation of the interventions&#xD;
      and 4 weeks thereafter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Facilities for the exercise training program were not available for the study.&#xD;
  </why_stopped>
  <start_date type="Actual">February 20, 2018</start_date>
  <completion_date type="Anticipated">October 2021</completion_date>
  <primary_completion_date type="Anticipated">October 2021</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Capillary density</measure>
    <time_frame>6 months</time_frame>
    <description>Number of spontaneously perfused skin capillaries per mm2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Microvascular reactivity assessed by laser speckle contrast imaging</measure>
    <time_frame>6 months</time_frame>
    <description>Skin microvascular flow in arbitrary perfusion units</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>HIIT only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Volunteers will be submitted to high-intensity interval training (HIIT) performed in fed state</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CT+FAST</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Volunteers will be submitted to continous training (CT) performed in the fasting state</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CT only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Volunteers will be submitted to continous training (CT) performed in fed state.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIIT+FAST</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Volunteers will be submitted to high-intensity interval training (HIIT) performed in the fasting state.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High-intensity interval exercise training in the fed state</intervention_name>
    <description>High-intensity interval exercise training in the fed state</description>
    <arm_group_label>HIIT only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Continous exercise training in the fed state</intervention_name>
    <description>Continous exercise training in the fed state</description>
    <arm_group_label>CT only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High-intensity interval exercise training in the fasting state</intervention_name>
    <description>High-intensity interval exercise training in the fasting state</description>
    <arm_group_label>HIIT+FAST</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Continous exercise training in the fasting state</intervention_name>
    <description>Continous exercise training in the fasting state</description>
    <arm_group_label>CT+FAST</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female gender&#xD;
&#xD;
          -  Age≥ 30 years and ≤50 years&#xD;
&#xD;
          -  Premenopausal status&#xD;
&#xD;
          -  Body mass index &gt;25 kg/m2&#xD;
&#xD;
          -  At least one of the following:&#xD;
&#xD;
        waist circumference ≥80 cm (women); triglycerides ≥150 mg/dl or treatment for this lipid&#xD;
        abnormality; High density-lipoprotein cholesterol &lt;50 mg/dl (women), or treatment for this&#xD;
        abnormality; fasting plasma glucose ≥100 mg/dl&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any cardiovascular disease, including systemic hypertension&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Chronic pulmonary disease&#xD;
&#xD;
          -  Any systemic disease or condition that might reduce the adherence or tolerance to&#xD;
             exercise or fasting&#xD;
&#xD;
          -  Orthopedic or neurologic conditions that might impair exercise training&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Abnormalities elicited at exercise treadmill testing that preclude the initiation of&#xD;
             exercise training&#xD;
&#xD;
          -  Current engagement in any exercise training protocol&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>EDUARDO V TIBIRICA, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Innstitute of Cardiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institute of Cardiology, Ministry of Health, Brazil</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>22240-006</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>March 11, 2019</last_update_submitted>
  <last_update_submitted_qc>March 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Institute of Cardiology, Laranjeiras, Brazil</investigator_affiliation>
    <investigator_full_name>Eduardo Tibirica, MD, PhD</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Microcirculation</keyword>
  <keyword>Endothelial function</keyword>
  <keyword>Laser speckle imaging</keyword>
  <keyword>Capillary density</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</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/NCT03236285
org study id: CAAE:69240017.1.0000.5272
nct id: NCT03236285
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study investigates the effects of high intensity interval training (HIIT) versus
      continuous training (CT), combined or not with fasting, on capillary density, microvascular
      function, cardiometabolic risk markers, functional capacity, and quality of life, in
      overweight or obese sedentary women with cardiometabolic risk factors. The use of HIIT could
      promote greater improvements in these parameters than CT. Furthermore, the positive effects
      of exercise may increase when it is performed in the fasting state, compared to exercise
      performed in the fed state.
Physical inactivity and increased caloric intake play important roles in the pathophysiology
      of obesity. Increases of physical activity and modifications of eating behaviors are
      first-line interventions which, however, are not easily implemented, and lack of time to
      exercise and difficulties in coping with different diets are common reasons for failure.
      High-intensity interval training (HIIT) is a "faster" alternative to moderate-intensity
      continuous training (CT). Conversely, intermittent fasting is also an alternative to more
      complex diets, as it restricts caloric intake to a specified period of time without major
      diet composition changes. The combination of HIIT and fasting may therefore provide
      incremental benefits.

      Sedentary women aged ≥ 30 years and ≤50 years, with body mass index ≥25 kg/m2 and
      cardiometabolic risk factors, will be randomized to HIIT performed in the fasting state, HIIT
      performed in the fed state, CT in the fasting state or CT in the fed state. Cardiometabolic
      parameters, anthropometric indices, cardiorespiratory fitness, quality of life and
      microvascular function (cutaneous capillary density and microvascular reactivity evaluated by
      laser speckle contrast imaging) will be evaluated before the initiation of the interventions
      and 4 weeks thereafter.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Capillary density
time frame: 6 months
description: Number of spontaneously perfused skin capillaries per mm2
measure: Microvascular reactivity assessed by laser speckle contrast imaging
time frame: 6 months
description: Skin microvascular flow in arbitrary perfusion units
arm group label: HIIT only
arm group type: Experimental
description: Volunteers will be submitted to high-intensity interval training (HIIT) performed in fed state
arm group label: CT+FAST
arm group type: Experimental
description: Volunteers will be submitted to continous training (CT) performed in the fasting state
arm group label: CT only
arm group type: Experimental
description: Volunteers will be submitted to continous training (CT) performed in fed state.
arm group label: HIIT+FAST
arm group type: Experimental
description: Volunteers will be submitted to high-intensity interval training (HIIT) performed in the fasting state.
intervention type: Behavioral
intervention name: High-intensity interval exercise training in the fed state
description: High-intensity interval exercise training in the fed state
arm group label: HIIT only
intervention type: Behavioral
intervention name: Continous exercise training in the fed state
description: Continous exercise training in the fed state
arm group label: CT only
intervention type: Behavioral
intervention name: High-intensity interval exercise training in the fasting state
description: High-intensity interval exercise training in the fasting state
arm group label: HIIT+FAST
intervention type: Behavioral
intervention name: Continous exercise training in the fasting state
description: Continous exercise training in the fasting state
arm group label: CT+FAST
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: EDUARDO V TIBIRICA, MD, PhD
role: Principal Investigator
affiliation: National Innstitute of Cardiology
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: National Institute of Cardiology, Laranjeiras, Brazil
investigator full name: Eduardo Tibirica, MD, PhD
investigator title: MD, PhD
mesh term: Overweight