<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/NCT02260232</url>
  </required_header>
  <id_info>
    <org_study_id>UEM_ASISA_1</org_study_id>
    <nct_id>NCT02260232</nct_id>
  </id_info>
  <brief_title>Worksite Exercise Intervention Effects on Cardiovascular Disease Risk Factors and Physical Activity Levels Among Healthy Employees</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Europea de Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Europea de Madrid</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: To investigate the effects of a one-year worksite individual exercise intervention&#xD;
      on lifestyle-related modifiable health risks, physical capacity and work performance.&#xD;
&#xD;
      Methods: Two hundred ninety-five employees volunteered to participate (n=191 women, n=104&#xD;
      men), aged 38 ± 8 years and body mass index (BMI), 24.71 ± 3.79. Measures of physical&#xD;
      activity levels were assessed by the long self-administrated version of the International&#xD;
      Physical Activity Questionnaire-Long Form (IPAQ-L), and all subjects performed a maximal&#xD;
      cardiopulmonary treadmill graded exercise test. Blood samples and anthropometry measures were&#xD;
      collected from participants at baseline survey, at 6 months and 1-year after. Components of&#xD;
      the program included supervised moderate to high intensity cardiorespiratory exercise,&#xD;
      resistance training, and flexibility.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2010</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</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>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>International Physical Activity Questionnaire-Long Form (IPAQ-L)</measure>
    <time_frame>1 week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Graded cardiorespiratory fitness exercise test</measure>
    <time_frame>1 week</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">295</enrollment>
  <condition>Exercise Therapy</condition>
  <arm_group>
    <arm_group_label>exercise intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Components of the program included supervised moderate to high intensity cardiorespiratory exercise, resistance training, and flexibility.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>exercise training</intervention_name>
    <arm_group_label>exercise intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Working in ASISA company, middle-age (20-60)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        No medical condition contraindicating exercise participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>October 6, 2014</last_update_submitted>
  <last_update_submitted_qc>October 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Europea de Madrid</investigator_affiliation>
    <investigator_full_name>Oscar Garcia Lopez</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT02260232
org study id: UEM_ASISA_1
nct id: NCT02260232
lead sponsor: 
has dmc: No
Objective: To investigate the effects of a one-year worksite individual exercise intervention
      on lifestyle-related modifiable health risks, physical capacity and work performance.

      Methods: Two hundred ninety-five employees volunteered to participate (n=191 women, n=104
      men), aged 38 ± 8 years and body mass index (BMI), 24.71 ± 3.79. Measures of physical
      activity levels were assessed by the long self-administrated version of the International
      Physical Activity Questionnaire-Long Form (IPAQ-L), and all subjects performed a maximal
      cardiopulmonary treadmill graded exercise test. Blood samples and anthropometry measures were
      collected from participants at baseline survey, at 6 months and 1-year after. Components of
      the program included supervised moderate to high intensity cardiorespiratory exercise,
      resistance training, and flexibility.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Outcomes Assessor)
measure: International Physical Activity Questionnaire-Long Form (IPAQ-L)
time frame: 1 week
measure: Graded cardiorespiratory fitness exercise test
time frame: 1 week
arm group label: exercise intervention
arm group type: Experimental
description: Components of the program included supervised moderate to high intensity cardiorespiratory exercise, resistance training, and flexibility.
arm group label: control
arm group type: No Intervention
intervention type: Other
intervention name: exercise training
arm group label: exercise intervention
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Universidad Europea de Madrid
investigator full name: Oscar Garcia Lopez
investigator title: Professor