<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/NCT03293264</url>
  </required_header>
  <id_info>
    <org_study_id>RebVW</org_study_id>
    <nct_id>NCT03293264</nct_id>
  </id_info>
  <brief_title>Exercise Training on Metabolic Syndrome Severity in Employees</brief_title>
  <official_title>Effects of a Workplace Health Service Program in Employees With Diagnosed Metabolic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hannover Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Volkswagen AG</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hannover Medical School</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>
      Hypothesis: An occupational 6 months physical exercise training will lead to better health&#xD;
      behaviour and improve the severity of the metabolic syndrome.&#xD;
&#xD;
      312 subjects will be assigned to either an intervention or a waiting-control-group. The&#xD;
      intervention group will receive instructions with the aim to perform 150 min exercise&#xD;
      training per week. Exercise consists of endurance, strength and coordination training. A&#xD;
      feedback system guided by sports scientists will be installed for all subjects in the&#xD;
      intervention group using activity monitoring (wearable). After 6 months training subjects&#xD;
      from the intervention group will be assigned to one of the following groups for follow-up&#xD;
      observation from month 6 to months 12:&#xD;
&#xD;
        -  training with personal/individual feedback from sport scientist&#xD;
&#xD;
        -  training with automated feedback using activity monitoring Tools (wearable)&#xD;
&#xD;
        -  training without further feedback Subjects assigned to the control group will be&#xD;
           provided with information on low intensity motion exercises. After 6 months in the&#xD;
           control group subjects will be provided with the same exercise intervention as the&#xD;
           intervention for a duration of 6 months.&#xD;
&#xD;
      Study visits will be conducted at month 0, month 6, month 12, and a long-term follow-up at&#xD;
      month 24..&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 17, 2017</start_date>
  <completion_date type="Anticipated">July 8, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 17, 2022</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>Health Services Research</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Metabolic Syndrome (MetS) -Z-score</measure>
    <time_frame>6 months 12 months, 24 months</time_frame>
    <description>Z-Score (arbitrary unit, ranging from -2 to 2), assessed and calculated from the 5 established components of the metabolic syndrome: triglycerides, HDL cholesterol, fasting glucose, waist circumference, and systolic blood pressure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Work-Ability-Index (WAI)</measure>
    <time_frame>6 months, 12 months, 24 months</time_frame>
    <description>score of WAI questionnaire, (Outcome work ability score: Minimum 1 Point, Maximum 49 Points)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Health-related quality of live: score of SF36 questionnaire</measure>
    <time_frame>6 months, 12 months, 24 months</time_frame>
    <description>score of SF36 questionnaire (outcomes: physical component score: Minimum 1 Point, Maximum 100 Points, mental component score: Minimum 1 Point, Maximum 100 Points)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Pmax</measure>
    <time_frame>6 months</time_frame>
    <description>Maximum workload reached in an graded exercise test (watt/kg Body Weight).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Body weight</measure>
    <time_frame>6 months</time_frame>
    <description>kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in body composition</measure>
    <time_frame>6 months, 12 months, 24 months</time_frame>
    <description>fat mass (kg), fat free mass (kg), visceral fat mass (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in adherence to training program</measure>
    <time_frame>6 months, 12 months, 24 months</time_frame>
    <description>percentage (%) of time (150 min per week) spend on exercising (minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Anxiety- and depression severity</measure>
    <time_frame>6 months, 12 months, 24 months</time_frame>
    <description>Hospital Anxiety and Depression Scale, (outcomes: amxiety severity: Minimum 1 Point, Maximum 21 Points, Depression severity: Minimum 1 Point, Maximum 21 Points)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">314</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Exercise training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will be encouraged to perform 150 min of exercise training per week for 6 months. Subjects will be provided with individual feedback and exercise Training prescriptions. After month 6 subjects will be randomized to three different groups for follow-up observation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting-control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will be provided with general informations on a healthy lifestyle. After 6 months wait-list-control months subjects will receive the guided exercise training intervention for 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise training group</intervention_name>
    <description>Exercise training will consist of 3 - 6 sessions per week and will cumulate in 150 min net exercise time per week. Heart rates during exercise sessions will be monitored with the aim of physical activities at moderate-intensity. Exercises will be individualized to reach the best possible improvements to the cardiovascular and musculoskeletal system. Possible disciples will include but are not limited to: cycling, rowing (ergometer), swimming, walking, nordic-walking, running, arm-cycle-ergometer or cross-trainer as well as fitness courses offered from occupational or private providers. Everyday activities which reach an effective heart rate range can account for exercise training on a home-based basis .&#xD;
Advise on complementary individual strength and coordination exercises will be added to the training program. A nutrition analyses will be completed by every subject to account for special needs of the metabolic syndrome.</description>
    <arm_group_label>Exercise training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  3 out of 5 parameters of the metabolic syndrome&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ongoing participation in occupational health service&#xD;
&#xD;
          -  clinical relevant acute or chronic infections&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  surgery dating back less than 8 weeks&#xD;
&#xD;
          -  artificial joint replacement dating back less than 6 months&#xD;
&#xD;
          -  tumor disease dating back less than 5 years&#xD;
&#xD;
          -  every other disease or relevant functional disorder not allowing to participate in&#xD;
             regular physical exercise&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Axel Haverich, Prof. Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Hannover Medical School, Department of Cardiothoracic, Transplantation and Vascular Surgery (HTTG)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Uwe Tegtbur, Prof. Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Hannover Medical School, Institute for Sports Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HannoverMS</name>
      <address>
        <city>Hannover</city>
        <state>Lower Saxony</state>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>March 18, 2021</last_update_submitted>
  <last_update_submitted_qc>March 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>metabolic syndrome</keyword>
  <keyword>exercise training</keyword>
  <keyword>employees</keyword>
  <keyword>workplace</keyword>
  <keyword>operational health service</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/NCT03293264
org study id: RebVW
nct id: NCT03293264
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hypothesis: An occupational 6 months physical exercise training will lead to better health
      behaviour and improve the severity of the metabolic syndrome.

      312 subjects will be assigned to either an intervention or a waiting-control-group. The
      intervention group will receive instructions with the aim to perform 150 min exercise
      training per week. Exercise consists of endurance, strength and coordination training. A
      feedback system guided by sports scientists will be installed for all subjects in the
      intervention group using activity monitoring (wearable). After 6 months training subjects
      from the intervention group will be assigned to one of the following groups for follow-up
      observation from month 6 to months 12:

        -  training with personal/individual feedback from sport scientist

        -  training with automated feedback using activity monitoring Tools (wearable)

        -  training without further feedback Subjects assigned to the control group will be
           provided with information on low intensity motion exercises. After 6 months in the
           control group subjects will be provided with the same exercise intervention as the
           intervention for a duration of 6 months.

      Study visits will be conducted at month 0, month 6, month 12, and a long-term follow-up at
      month 24..
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Investigator)
measure: Change from baseline in Metabolic Syndrome (MetS) -Z-score
time frame: 6 months 12 months, 24 months
description: Z-Score (arbitrary unit, ranging from -2 to 2), assessed and calculated from the 5 established components of the metabolic syndrome: triglycerides, HDL cholesterol, fasting glucose, waist circumference, and systolic blood pressure.
measure: Change from baseline in Work-Ability-Index (WAI)
time frame: 6 months, 12 months, 24 months
description: score of WAI questionnaire, (Outcome work ability score: Minimum 1 Point, Maximum 49 Points)
measure: Change from baseline in Health-related quality of live: score of SF36 questionnaire
time frame: 6 months, 12 months, 24 months
description: score of SF36 questionnaire (outcomes: physical component score: Minimum 1 Point, Maximum 100 Points, mental component score: Minimum 1 Point, Maximum 100 Points)
measure: Change from baseline in Pmax
time frame: 6 months
description: Maximum workload reached in an graded exercise test (watt/kg Body Weight).
measure: Change from baseline in Body weight
time frame: 6 months
description: kg
measure: Change from baseline in body composition
time frame: 6 months, 12 months, 24 months
description: fat mass (kg), fat free mass (kg), visceral fat mass (kg)
measure: Change from baseline in adherence to training program
time frame: 6 months, 12 months, 24 months
description: percentage (%) of time (150 min per week) spend on exercising (minutes)
measure: Change from baseline in Anxiety- and depression severity
time frame: 6 months, 12 months, 24 months
description: Hospital Anxiety and Depression Scale, (outcomes: amxiety severity: Minimum 1 Point, Maximum 21 Points, Depression severity: Minimum 1 Point, Maximum 21 Points)
arm group label: Exercise training group
arm group type: Experimental
description: The intervention group will be encouraged to perform 150 min of exercise training per week for 6 months. Subjects will be provided with individual feedback and exercise Training prescriptions. After month 6 subjects will be randomized to three different groups for follow-up observation.
arm group label: Waiting-control group
arm group type: No Intervention
description: The control group will be provided with general informations on a healthy lifestyle. After 6 months wait-list-control months subjects will receive the guided exercise training intervention for 6 months.
intervention type: Behavioral
intervention name: Exercise training group
description: Exercise training will consist of 3 - 6 sessions per week and will cumulate in 150 min net exercise time per week. Heart rates during exercise sessions will be monitored with the aim of physical activities at moderate-intensity. Exercises will be individualized to reach the best possible improvements to the cardiovascular and musculoskeletal system. Possible disciples will include but are not limited to: cycling, rowing (ergometer), swimming, walking, nordic-walking, running, arm-cycle-ergometer or cross-trainer as well as fitness courses offered from occupational or private providers. Everyday activities which reach an effective heart rate range can account for exercise training on a home-based basis .
Advise on complementary individual strength and coordination exercises will be added to the training program. A nutrition analyses will be completed by every subject to account for special needs of the metabolic syndrome.
arm group label: Exercise training group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Axel Haverich, Prof. Dr.
role: Study Chair
affiliation: Hannover Medical School, Department of Cardiothoracic, Transplantation and Vascular Surgery (HTTG)
last name: Uwe Tegtbur, Prof. Dr.
role: Study Chair
affiliation: Hannover Medical School, Institute for Sports Medicine
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Metabolic Syndrome
mesh term: Syndrome
sharing ipd: No