<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/NCT03297333</url>
  </required_header>
  <id_info>
    <org_study_id>16-1208-4C-1</org_study_id>
    <nct_id>NCT03297333</nct_id>
  </id_info>
  <brief_title>Effects of Exercise Mode on Cardiac Fat and Function</brief_title>
  <official_title>Effects of Exercise Mode on Cardiac Fat and Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southern Illinois University Edwardsville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southern Illinois University Edwardsville</source>
  <oversight_info>
    <has_dmc>Yes</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 overall goal of this project is to study the effects of exercise energy expenditure&#xD;
      matched vigorous dynamic resistance training and aerobic training on cardiac fat, and its&#xD;
      relationship to cardiac function and geometry using cardiac Magnetic Resonance Imaging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Exercise-induced weight-loss is one of the most common strategies for reducing excess fat in&#xD;
      overweight and obese individuals. Although vigorous intensity may be more favorable promoting&#xD;
      positive cardiac adaptations compared to low-moderate intensity, evidence of the positive&#xD;
      effects of different exercise modes needs to be explored to allow for realistic comparisons&#xD;
      with other strategies. Research using cardiac Magnetic Resonance Imaging that compares the&#xD;
      effects of different modes of exercise - matched by exercise energy expenditure - on&#xD;
      epicardial adipose tissue and paracardial adipose tissue, and how these interventions modify&#xD;
      cardiac function and geometry have not been previously explored in obesity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Covid/19&#xD;
  </why_stopped>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">March 16, 2020</completion_date>
  <primary_completion_date type="Actual">March 16, 2020</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>Changes in Epicardial adipose tissue (EAT)</measure>
    <time_frame>2 assessment points: at baseline and week 4</time_frame>
    <description>EAT will be measured using cardiac Magnetic Resonance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Vascular Health</measure>
    <time_frame>2 assessment points: at baseline and week 4</time_frame>
    <description>Atrial stiffness will be measured using a pulse wave analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Paracardial adipose tissue (PAT)</measure>
    <time_frame>2 assessment points: at baseline and week 4</time_frame>
    <description>PAT will be measured using cardiac Magnetic Resonance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Body Composition</measure>
    <time_frame>2 assessment points: at baseline and week 4</time_frame>
    <description>Body composition will be measured using dual-energy x-ray absorptiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Cardiorespiratory Function</measure>
    <time_frame>2 assessment points: at baseline and week 4</time_frame>
    <description>Cardiorespiratory Function will be measured on a treadmill with a metabolic cart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Muscular Strength</measure>
    <time_frame>2 assessment points: at baseline and week 4</time_frame>
    <description>Muscular Strength will be assessed by 1 repetition maximum (1RM) test</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Resistance training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Resistance training will consist of a supervised circuit training 3 sessions/week for approximately 45-50 min/session. The circuit will include 7 strength exercises engaging the major muscle groups (leg press, rows, back squats, weighted crunches, deadlifts, bench press, and squat jumps with weights). The participants will perform 3 sets of 10 repetitions with resting periods of 30 seconds between exercises, and 2 minutes between sets. The overall OMNI-Resistance Exercise Scale per set will range between 8-10. Heart rate and exercise energy expenditure during the workout will be monitored. The load will be changed depending on the participants' perception when needed. In addition, the intensity will be monitored assessing Lactate concentrations at baseline and at the end of each session. Circuit will be repeated until meeting the targeted exercise energy expenditure of 450-500 kcal/session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aerobic interval training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aerobic interval will consist of a supervised aerobic interval training sessions 3 times/week. Duration will range between 45-50 min/session depending on the exercise energy expenditure. Each interval will have a total duration of 5 min, and it will be divided into 2 periods. The first period will consist of 3 minutes of high-intensity activity, and the second period the intensity will be reduced for 2 minutes. The speed/incline will be changed depending on the participants' heart rate and perception using the Borg's rating of perceived exertion as needed. Heart rate and exercise energy expenditure during the workout will be monitored. Intensity will be monitored assessing Lactate concentrations at the end of each session. Intervals will be repeated until meeting the targeted exercise energy expenditure (450-500 kcal/session).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group will not participate in the training programs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resistance training</intervention_name>
    <description>The resistance training group</description>
    <arm_group_label>Resistance training group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic interval training</intervention_name>
    <description>The aerobic interval training group</description>
    <arm_group_label>Aerobic interval training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sedentary&#xD;
&#xD;
          -  Caucasian&#xD;
&#xD;
          -  BMI &gt;30 kg/m2 and &lt; 39.9 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known cardiovascular, metabolic, pulmonary disease or conditions&#xD;
&#xD;
          -  Muscular-skeletal injuries&#xD;
&#xD;
          -  Taking medications that affect endocrine or cardiovascular function&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  Being engaged in low intensity strength training more than two times per week or&#xD;
             moderate-high intensity of any type of frequency&#xD;
&#xD;
          -  Being pregnant&#xD;
&#xD;
          -  Cigarette smoking&#xD;
&#xD;
          -  Having non-removable pieces or devices incompatible with DXA and CMR assessment.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Fernandez del Valle, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southern Illinois University of Edwardsville</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southern Illinois University of Edwardsville</name>
      <address>
        <city>Edwardsville</city>
        <state>Illinois</state>
        <zip>62026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Exercise</keyword>
  <keyword>Cardiac Fat</keyword>
  <keyword>Cardiac Magnetic Resonance</keyword>
  <keyword>Vascular Health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT03297333
org study id: 16-1208-4C-1
nct id: NCT03297333
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The overall goal of this project is to study the effects of exercise energy expenditure
      matched vigorous dynamic resistance training and aerobic training on cardiac fat, and its
      relationship to cardiac function and geometry using cardiac Magnetic Resonance Imaging.
Exercise-induced weight-loss is one of the most common strategies for reducing excess fat in
      overweight and obese individuals. Although vigorous intensity may be more favorable promoting
      positive cardiac adaptations compared to low-moderate intensity, evidence of the positive
      effects of different exercise modes needs to be explored to allow for realistic comparisons
      with other strategies. Research using cardiac Magnetic Resonance Imaging that compares the
      effects of different modes of exercise - matched by exercise energy expenditure - on
      epicardial adipose tissue and paracardial adipose tissue, and how these interventions modify
      cardiac function and geometry have not been previously explored in obesity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in Epicardial adipose tissue (EAT)
time frame: 2 assessment points: at baseline and week 4
description: EAT will be measured using cardiac Magnetic Resonance
measure: Changes in Vascular Health
time frame: 2 assessment points: at baseline and week 4
description: Atrial stiffness will be measured using a pulse wave analysis
measure: Changes in Paracardial adipose tissue (PAT)
time frame: 2 assessment points: at baseline and week 4
description: PAT will be measured using cardiac Magnetic Resonance
measure: Changes in Body Composition
time frame: 2 assessment points: at baseline and week 4
description: Body composition will be measured using dual-energy x-ray absorptiometry
measure: Changes in Cardiorespiratory Function
time frame: 2 assessment points: at baseline and week 4
description: Cardiorespiratory Function will be measured on a treadmill with a metabolic cart
measure: Changes in Muscular Strength
time frame: 2 assessment points: at baseline and week 4
description: Muscular Strength will be assessed by 1 repetition maximum (1RM) test
arm group label: Resistance training group
arm group type: Experimental
description: Resistance training will consist of a supervised circuit training 3 sessions/week for approximately 45-50 min/session. The circuit will include 7 strength exercises engaging the major muscle groups (leg press, rows, back squats, weighted crunches, deadlifts, bench press, and squat jumps with weights). The participants will perform 3 sets of 10 repetitions with resting periods of 30 seconds between exercises, and 2 minutes between sets. The overall OMNI-Resistance Exercise Scale per set will range between 8-10. Heart rate and exercise energy expenditure during the workout will be monitored. The load will be changed depending on the participants' perception when needed. In addition, the intensity will be monitored assessing Lactate concentrations at baseline and at the end of each session. Circuit will be repeated until meeting the targeted exercise energy expenditure of 450-500 kcal/session.
arm group label: Aerobic interval training group
arm group type: Experimental
description: Aerobic interval will consist of a supervised aerobic interval training sessions 3 times/week. Duration will range between 45-50 min/session depending on the exercise energy expenditure. Each interval will have a total duration of 5 min, and it will be divided into 2 periods. The first period will consist of 3 minutes of high-intensity activity, and the second period the intensity will be reduced for 2 minutes. The speed/incline will be changed depending on the participants' heart rate and perception using the Borg's rating of perceived exertion as needed. Heart rate and exercise energy expenditure during the workout will be monitored. Intensity will be monitored assessing Lactate concentrations at the end of each session. Intervals will be repeated until meeting the targeted exercise energy expenditure (450-500 kcal/session).
arm group label: Control group
arm group type: No Intervention
description: Participants in the control group will not participate in the training programs.
intervention type: Other
intervention name: Resistance training
description: The resistance training group
arm group label: Resistance training group
intervention type: Other
intervention name: Aerobic interval training
description: The aerobic interval training group
arm group label: Aerobic interval training group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maria Fernandez del Valle, PhD
role: Principal Investigator
affiliation: Southern Illinois University of Edwardsville
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity