<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/NCT03036332</url>
  </required_header>
  <id_info>
    <org_study_id>RATMiranda1</org_study_id>
    <nct_id>NCT03036332</nct_id>
  </id_info>
  <brief_title>Exercise Training and Metabolic Syndrome</brief_title>
  <official_title>Effects of Aerobic Interval Training on Clinical Biomarkers and Quality of Life in Metabolic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Estadual Paulista Júlio de Mesquita Filho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Estadual Paulista Júlio de Mesquita Filho</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 present study aimed to determine the effects of 16 weeks of aerobic interval training on&#xD;
      quality of life and a set of clinical biomarkers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Besides the traditional metabolic syndrome risk factors (dyslipidemia, raised blood pressure,&#xD;
      central obesity and dysglycemia) subclinical disorders related to chronic inflammation and&#xD;
      cell damage have been reported on metabolic syndrome. Therefore, regarding the systemic&#xD;
      feature of metabolic syndrome, we investigated an new approach of aerobic interval training&#xD;
      on several clinical biomarkers widely used. Such training used differs from current aerobic&#xD;
      protocols in order to attenuate metabolic and musculoskeletal overload on untrained and&#xD;
      unhealthy subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2015</start_date>
  <completion_date type="Actual">December 10, 2016</completion_date>
  <primary_completion_date type="Actual">December 10, 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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pro-inflammatory marker</measure>
    <time_frame>16 weeks</time_frame>
    <description>Serum levels of C-reactive protein</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>16 weeks</time_frame>
    <description>The Medical Outcomes Study-Short Form 36 (SF-36)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A set of clinical biomarkers</measure>
    <time_frame>16 weeks</time_frame>
    <description>Serum levels lof Homocysteine; Creatinine, Creatine kinase (ck); creatine kinase MB (ck-mb); Troponin t; aspartate aminotransferase; alanine aminotransferase; and complete blood count.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aerobic interval training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The participants performed only initial evaluation and at the end of the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Aerobic interval training</intervention_name>
    <description>Carried out 3 times per week for 16 weeks</description>
    <arm_group_label>intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having metabolic syndrome according to international diabetes foundations definition&#xD;
             (IDF).&#xD;
&#xD;
          -  Age between 35 - 60 years and untrained subjects.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Musculotendinous or osteoarticular injuries in the lower limbs and/or spine&#xD;
&#xD;
          -  Chronic pulmonary diseases&#xD;
&#xD;
          -  Neurological disorders&#xD;
&#xD;
          -  Kidney failure&#xD;
&#xD;
          -  High-risk cardiovascular diseases (Unstable angina pectoris, Uncompensated heart&#xD;
             failure, complex ventricular arrhythmias or myocardial infarction during the last&#xD;
             month).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rodolfo AT Miranda, Me</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Estadual Paulista Júlio de Mesquita</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>January 27, 2017</last_update_submitted>
  <last_update_submitted_qc>January 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Estadual Paulista Júlio de Mesquita Filho</investigator_affiliation>
    <investigator_full_name>Rodolfo Augusto Travagin Miranda</investigator_full_name>
    <investigator_title>Mr. Rodolfo Augusto Travagin Miranda</investigator_title>
  </responsible_party>
  <keyword>aerobic interval training</keyword>
  <keyword>biomarkers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT03036332
org study id: RATMiranda1
nct id: NCT03036332
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The present study aimed to determine the effects of 16 weeks of aerobic interval training on
      quality of life and a set of clinical biomarkers.
Besides the traditional metabolic syndrome risk factors (dyslipidemia, raised blood pressure,
      central obesity and dysglycemia) subclinical disorders related to chronic inflammation and
      cell damage have been reported on metabolic syndrome. Therefore, regarding the systemic
      feature of metabolic syndrome, we investigated an new approach of aerobic interval training
      on several clinical biomarkers widely used. Such training used differs from current aerobic
      protocols in order to attenuate metabolic and musculoskeletal overload on untrained and
      unhealthy subjects.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Pro-inflammatory marker
time frame: 16 weeks
description: Serum levels of C-reactive protein
measure: Quality of life
time frame: 16 weeks
description: The Medical Outcomes Study-Short Form 36 (SF-36)
measure: A set of clinical biomarkers
time frame: 16 weeks
description: Serum levels lof Homocysteine; Creatinine, Creatine kinase (ck); creatine kinase MB (ck-mb); Troponin t; aspartate aminotransferase; alanine aminotransferase; and complete blood count.
arm group label: intervention
arm group type: Experimental
description: Aerobic interval training
arm group label: Control group
arm group type: No Intervention
description: The participants performed only initial evaluation and at the end of the study
intervention type: Behavioral
intervention name: Aerobic interval training
description: Carried out 3 times per week for 16 weeks
arm group label: intervention
criteria: 
gender: All
minimum age: 35 Years
maximum age: 60 Years
healthy volunteers: No
last name: Rodolfo AT Miranda, Me
role: Principal Investigator
affiliation: Universidade Estadual Paulista Júlio de Mesquita
responsible party type: Principal Investigator
investigator affiliation: Universidade Estadual Paulista Júlio de Mesquita Filho
investigator full name: Rodolfo Augusto Travagin Miranda
investigator title: Mr. Rodolfo Augusto Travagin Miranda
mesh term: Metabolic Syndrome
mesh term: Syndrome
sharing ipd: No