<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/NCT01676870</url>
  </required_header>
  <id_info>
    <org_study_id>2011/1230</org_study_id>
    <nct_id>NCT01676870</nct_id>
  </id_info>
  <brief_title>Exercise in Prevention of Metabolic Syndrome</brief_title>
  <acronym>EX-MET</acronym>
  <official_title>Exercise in Prevention of Metabolic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Helse Stavanger HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The University of Queensland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>KJ Fisiosport</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</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 primary objective of the study is to compare in a real-world setting the efficacy of&#xD;
      traditional training (today's guideline, vigorously or moderate exercise) and amount of&#xD;
      aerobic interval training (1-AIT) in reduction of risk factors constituting metabolic&#xD;
      syndrome.&#xD;
&#xD;
      The secondary objective is to compare the efficacy of traditional moderate training (today's&#xD;
      guideline) and amount of aerobic interval training (1-AIT vs. 4-AIT) in improving aerobic&#xD;
      capacity, cardiovascular function, skeletal muscle contractile function, skeletal muscle&#xD;
      energy metabolism, left ventricle systolic and diastolic function at rest and right&#xD;
      ventricular function.&#xD;
&#xD;
      The investigators hypothesized that aerobic interval training would reverse features of the&#xD;
      metabolic syndrome more than traditional training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study describes a randomized multicenter clinical trial designed to test the hypothesis&#xD;
      that a 16-week program, with one year follow up of vigorously exercise defined from today's&#xD;
      guidelines (performed as 4-AIT (4x4min aerobe interval training)) yields larger beneficial&#xD;
      effects in reducing risk factors constituting the metabolic syndrome than continuously&#xD;
      moderate intensity exercise (CME) defined from today's guidelines.&#xD;
&#xD;
      Furthermore, the importance of the amount of aerobic interval training remains unclear and it&#xD;
      is unknown how little &quot;one can get away with&quot; and still obtain substantial beneficial&#xD;
      cardiovascular effects. Therefore, the investigators will also determine whether one bout of&#xD;
      aerobe interval training (AIT) - 1-AIT = 1x4min aerobe interval training, can give beneficial&#xD;
      effects compared to 4-AIT and CME.&#xD;
&#xD;
      Evaluation criteria are risk factors constituting metabolic syndrome, aerobic capacity&#xD;
      measured as peak oxygen uptake and compliance to intervention. Assessments will be made&#xD;
      before and after the 16-week program, and at six month, and 1 and 3 years follow-up.&#xD;
      According to estimates based on data from previously studies, 3, 4 a total number of 465&#xD;
      patients randomized 1:1:1 to the three interventions gives 80% power to detect an effect of&#xD;
      4-AIT compared to 1-AIT/CME of 51% recovery versus 37% recovery from metabolic syndrome at&#xD;
      the 5% significance level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2012</start_date>
  <completion_date type="Actual">December 15, 2019</completion_date>
  <primary_completion_date type="Actual">December 15, 2019</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cardiovascular risk factors constituting metabolic syndrome</measure>
    <time_frame>up to 3 years</time_frame>
    <description>Endothelial function and blood pressure, biopsies from the m. vastus lateralis, Protein and expression levels, oxidized LDL and adiponectin in blood plasma</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">408</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>1x4 aerobic interval training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1x4min aerobic interval training (1-AIT), 3 times a week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4x4 aerobic interval training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4x4min aerobic interval training (4-AIT), vigorously exercise according to today's guidelines, 3 times a week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>traditional moderate training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>traditional moderate training (CME), moderate exercise at least 30 min, 5 days a week or more, according to today's guidelines</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>1x4 aerobic interval training</intervention_name>
    <description>endurance training as walking/running &quot;uphill&quot; 3 times/week for 16 weeks (2 supervised sessions (treadmill) and 1 at home each week) at 90% of Hfmax. Warm-up 10 min at 70% of maximal heart frequency (Hfmax), 5min cool-down.</description>
    <arm_group_label>1x4 aerobic interval training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>4x4 aerobic interval training</intervention_name>
    <description>endurance training as walking/running &quot;uphill&quot; 3 times/week for 16 weeks (2 supervised sessions (treadmill) and 1 at home each week) at 90% of Hfmax. Warm-up 10 min at 70% of maximal heart frequency (Hfmax), 3 min active pause between each interval, 5min cool-down.</description>
    <arm_group_label>4x4 aerobic interval training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>traditional moderate training</intervention_name>
    <description>moderate intensity treadmill training (50-70% of HRmax) for a minimum of 30min, 5 times a week for 16 weeks (2 supervised sessions and 3 or more home).</description>
    <arm_group_label>traditional moderate training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  metabolic syndrome defined according to the IDF-criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unstable angina&#xD;
&#xD;
          -  recent cardiac infarction (4weeks)&#xD;
&#xD;
          -  uncompensated heart failure&#xD;
&#xD;
          -  severe valvular illness&#xD;
&#xD;
          -  pulmonary disease&#xD;
&#xD;
          -  uncontrolled hypertension&#xD;
&#xD;
          -  kidney failure&#xD;
&#xD;
          -  orthopedic/neurological limitations&#xD;
&#xD;
          -  cardiomyopathy&#xD;
&#xD;
          -  planned operations during the research period&#xD;
&#xD;
          -  reluctant to sign the consent form&#xD;
&#xD;
          -  drug or alcohol abuse&#xD;
&#xD;
          -  participants in a parallel study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulrik Wisløff, PhD prof</last_name>
    <role>Study Director</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Human Movement Studies, University of Queensland</name>
      <address>
        <city>St Lucia</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Sao Paulo</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KJ Fisioterapi</name>
      <address>
        <city>Guayaquil</city>
        <country>Ecuador</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Internal Medicine, Cardiology, Sports Medicine Chair Dep. Prevention, Rehabilitation and Sports Medicine Faculty of Medicine University Hospital</name>
      <address>
        <city>Munich</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stavanger University Hospital</name>
      <address>
        <city>Stavanger</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Olavs hospital</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Ecuador</country>
    <country>Germany</country>
    <country>Norway</country>
  </location_countries>
  <removed_countries>
    <country>Croatia</country>
    <country>Italy</country>
    <country>Tunisia</country>
  </removed_countries>
  <reference>
    <citation>Tjonna AE, Ramos JS, Pressler A, Halle M, Jungbluth K, Ermacora E, Salvesen O, Rodrigues J, Bueno CR Jr, Munk PS, Coombes J, Wisloff U. EX-MET study: exercise in prevention on of metabolic syndrome - a randomized multicenter trial: rational and design. BMC Public Health. 2018 Apr 2;18(1):437. doi: 10.1186/s12889-018-5343-7.</citation>
    <PMID>29609582</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>February 6, 2020</last_update_submitted>
  <last_update_submitted_qc>February 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>exercise training</keyword>
  <keyword>exercise therapy</keyword>
  <keyword>physical fitness</keyword>
  <keyword>risk factors</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>
  <!-- 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/NCT01676870
org study id: 2011/1230
nct id: NCT01676870
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of the study is to compare in a real-world setting the efficacy of
      traditional training (today's guideline, vigorously or moderate exercise) and amount of
      aerobic interval training (1-AIT) in reduction of risk factors constituting metabolic
      syndrome.

      The secondary objective is to compare the efficacy of traditional moderate training (today's
      guideline) and amount of aerobic interval training (1-AIT vs. 4-AIT) in improving aerobic
      capacity, cardiovascular function, skeletal muscle contractile function, skeletal muscle
      energy metabolism, left ventricle systolic and diastolic function at rest and right
      ventricular function.

      The investigators hypothesized that aerobic interval training would reverse features of the
      metabolic syndrome more than traditional training.
This study describes a randomized multicenter clinical trial designed to test the hypothesis
      that a 16-week program, with one year follow up of vigorously exercise defined from today's
      guidelines (performed as 4-AIT (4x4min aerobe interval training)) yields larger beneficial
      effects in reducing risk factors constituting the metabolic syndrome than continuously
      moderate intensity exercise (CME) defined from today's guidelines.

      Furthermore, the importance of the amount of aerobic interval training remains unclear and it
      is unknown how little "one can get away with" and still obtain substantial beneficial
      cardiovascular effects. Therefore, the investigators will also determine whether one bout of
      aerobe interval training (AIT) - 1-AIT = 1x4min aerobe interval training, can give beneficial
      effects compared to 4-AIT and CME.

      Evaluation criteria are risk factors constituting metabolic syndrome, aerobic capacity
      measured as peak oxygen uptake and compliance to intervention. Assessments will be made
      before and after the 16-week program, and at six month, and 1 and 3 years follow-up.
      According to estimates based on data from previously studies, 3, 4 a total number of 465
      patients randomized 1:1:1 to the three interventions gives 80% power to detect an effect of
      4-AIT compared to 1-AIT/CME of 51% recovery versus 37% recovery from metabolic syndrome at
      the 5% significance level.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: cardiovascular risk factors constituting metabolic syndrome
time frame: up to 3 years
description: Endothelial function and blood pressure, biopsies from the m. vastus lateralis, Protein and expression levels, oxidized LDL and adiponectin in blood plasma
arm group label: 1x4 aerobic interval training
arm group type: Experimental
description: 1x4min aerobic interval training (1-AIT), 3 times a week
arm group label: 4x4 aerobic interval training
arm group type: Experimental
description: 4x4min aerobic interval training (4-AIT), vigorously exercise according to today's guidelines, 3 times a week
arm group label: traditional moderate training
arm group type: Active Comparator
description: traditional moderate training (CME), moderate exercise at least 30 min, 5 days a week or more, according to today's guidelines
intervention type: Behavioral
intervention name: 1x4 aerobic interval training
description: endurance training as walking/running "uphill" 3 times/week for 16 weeks (2 supervised sessions (treadmill) and 1 at home each week) at 90% of Hfmax. Warm-up 10 min at 70% of maximal heart frequency (Hfmax), 5min cool-down.
arm group label: 1x4 aerobic interval training
intervention type: Behavioral
intervention name: 4x4 aerobic interval training
description: endurance training as walking/running "uphill" 3 times/week for 16 weeks (2 supervised sessions (treadmill) and 1 at home each week) at 90% of Hfmax. Warm-up 10 min at 70% of maximal heart frequency (Hfmax), 3 min active pause between each interval, 5min cool-down.
arm group label: 4x4 aerobic interval training
intervention type: Behavioral
intervention name: traditional moderate training
description: moderate intensity treadmill training (50-70% of HRmax) for a minimum of 30min, 5 times a week for 16 weeks (2 supervised sessions and 3 or more home).
arm group label: traditional moderate training
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ulrik Wisløff, PhD prof
role: Study Director
affiliation: Norwegian University of Science and Technology
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Brazil
country: Ecuador
country: Germany
country: Norway
country: Croatia
country: Italy
country: Tunisia
citation: Tjonna AE, Ramos JS, Pressler A, Halle M, Jungbluth K, Ermacora E, Salvesen O, Rodrigues J, Bueno CR Jr, Munk PS, Coombes J, Wisloff U. EX-MET study: exercise in prevention on of metabolic syndrome - a randomized multicenter trial: rational and design. BMC Public Health. 2018 Apr 2;18(1):437. doi: 10.1186/s12889-018-5343-7.
PMID: 29609582
responsible party type: Sponsor
mesh term: Metabolic Syndrome
mesh term: Syndrome