<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/NCT03236597</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY000000866</org_study_id>
    <nct_id>NCT03236597</nct_id>
  </id_info>
  <brief_title>Assessing the Effects Of Treadmill On LPA, Sitting Time, and Cardiovascular Risk</brief_title>
  <official_title>Assessing the Effects Of Treadmill On Light Physical Activity, Sitting Time, And Cardiovascular Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</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 purpose of this study is to:&#xD;
&#xD;
        1. Evaluate the relative efficacy of a treadmill desk intervention on light physical&#xD;
           activity and sitting behaviors at work over four weeks;&#xD;
&#xD;
        2. Evaluate the relative efficacy of a treadmill desk intervention on the cardiovascular&#xD;
           risk profiles (blood pressure, body weight, body fat percentage) over a four-week&#xD;
           period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      American workers spend 70-80% of their time at work sitting at a desk, working on a computer,&#xD;
      talking on a telephone, and sitting in meetings. Traditional approaches to increase MVPA in&#xD;
      the workplace may not be sustainable as they require deliberate and dedicated time away from&#xD;
      work, and may be perceived as harmful to productivity. Sedentary behavior interventions, in&#xD;
      contrast, do not interfere with daily tasks and productivity and require small but cumulative&#xD;
      changes in posture and LPA throughout the workday.&#xD;
&#xD;
      Sedentary behavior interventions in the worksite, including those conducted by our team, have&#xD;
      shown promising effects. Studies that have used multi-level approaches targeting individual,&#xD;
      social, and environmental factors have been most effective. The most robust environmental&#xD;
      support has been the use of sit-stand workstations, providing distinct opportunities for&#xD;
      workers to reduce sitting while maintaining productivity. However, treadmill desks may&#xD;
      provide an even greater opportunity to both reduce sitting and increase LPA during the&#xD;
      workday. Thus, a pilot study is required to test the efficacy of this approach to reduce&#xD;
      sitting and increase LPA in the workplace.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2018</start_date>
  <completion_date type="Actual">December 8, 2019</completion_date>
  <primary_completion_date type="Actual">December 7, 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>Crossover Assignment</intervention_model>
    <intervention_model_description>A within-person, cross-over design will be used. Fifteen participants will take part in two conditions: 1) the treadmill desk: this intervention will ask participants to use a treadmill desk for a minimum of 30min per day for four weeks; and 2) the usual desk condition: participants will use their current workstation, as is, for four weeks. Participants will be randomly assigned to their initial intervention condition after baseline measures have been collected. In addition to the two condition months, there will be a one-week baseline period (to collected information on habitual activity level at work).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time spent sitting</measure>
    <time_frame>7-days</time_frame>
    <description>The change in time spent sitting as measured by the ActivPAL, from baseline to the final week of each intervention condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time spent standing</measure>
    <time_frame>7-days</time_frame>
    <description>The change in time spent standing as measured by the ActivPAL, from baseline to the final week of each intervention condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time spent moving</measure>
    <time_frame>7-days</time_frame>
    <description>The change in time spent moving as measured by the ActivPAL, from baseline to the final week of each intervention condition</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular risk: Blood pressure</measure>
    <time_frame>7-days</time_frame>
    <description>The change in the cardiovascular risk, as measured via blood pressure from baseline to the final week of each condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular risk: Body weight</measure>
    <time_frame>7-days</time_frame>
    <description>The change in the cardiovascular risk, as measured via body weight from baseline to the final week of each condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular risk: Percent body fat</measure>
    <time_frame>7-days</time_frame>
    <description>The change in the cardiovascular risk, as measured via percent body fat from baseline to the final week of each condition.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Sedentary Lifestyle</condition>
  <condition>Risk Factor, Cardiovascular</condition>
  <arm_group>
    <arm_group_label>Usual Desk</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>participants will work at their usual desk for four weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treadmill desk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be asked to use a treadmill desk for a minimum of 30 minutes per day for four weeks (Participants will sign up for a total of 30 minutes each day). Additional time may be spent on the treadmill, time permitting (two treadmills will be available to up to 10 people over the four week period).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treadmill desk</intervention_name>
    <description>A standing height desk with a treadmill attached.</description>
    <arm_group_label>Treadmill desk</arm_group_label>
    <other_name>ActiveStation Treadmill desks</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Not currently pregnant or planning to become pregnant during the 11 week study period.&#xD;
&#xD;
          -  Able to read and write in English.&#xD;
&#xD;
          -  No current use of a sit/stand or treadmill desk.&#xD;
&#xD;
          -  Work that is done in a predominately stationary position.&#xD;
&#xD;
          -  Working at UMN West Bank Office Building at least 30 hours per week.&#xD;
&#xD;
          -  Not currently meeting physical activity guidelines.&#xD;
&#xD;
          -  No balance issues (i.e. healthy vestibular system)&#xD;
&#xD;
          -  No contraindications to standing or walking&#xD;
&#xD;
          -  Weight stable for the past 12 months.&#xD;
&#xD;
          -  Taking no more than 3 prescription drugs, with stable dosage, over the past 12 months&#xD;
&#xD;
          -  Answer of no to all Physical Activity Readiness-Questionnaire (PAR-Q) questions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently pregnant or actively trying to become pregnant during the 14 week study&#xD;
             period.&#xD;
&#xD;
          -  Unable to read and write in English.&#xD;
&#xD;
          -  Working less than 30 hours per week.&#xD;
&#xD;
          -  Currently meeting physical activity guidelines.&#xD;
&#xD;
          -  Non-sedentary job.&#xD;
&#xD;
          -  Current use of treadmill desk&#xD;
&#xD;
          -  Any reported balance problems&#xD;
&#xD;
          -  Anyone with contraindications to standing or walking&#xD;
&#xD;
          -  Weight fluctuations of more than +/- 10% of their body weight in the past year&#xD;
&#xD;
          -  Individuals taking more than 4 prescription drugs and/or unstable dosage of&#xD;
             medications over the past 12 months if taking 3 or less.&#xD;
&#xD;
          -  Answer of yes to any PAR-Q questions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Minnesota West Bank Office Building</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>January 6, 2020</last_update_submitted>
  <last_update_submitted_qc>January 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Deidentified IPD for all primary and secondary outcome measures will be made available upon request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will become available within 6 months of study completion.</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by the Principal Investigator. Requestors will be required to sign a data access agreement.</ipd_access_criteria>
  </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/NCT03236597
org study id: STUDY000000866
nct id: NCT03236597
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to:

        1. Evaluate the relative efficacy of a treadmill desk intervention on light physical
           activity and sitting behaviors at work over four weeks;

        2. Evaluate the relative efficacy of a treadmill desk intervention on the cardiovascular
           risk profiles (blood pressure, body weight, body fat percentage) over a four-week
           period.
American workers spend 70-80% of their time at work sitting at a desk, working on a computer,
      talking on a telephone, and sitting in meetings. Traditional approaches to increase MVPA in
      the workplace may not be sustainable as they require deliberate and dedicated time away from
      work, and may be perceived as harmful to productivity. Sedentary behavior interventions, in
      contrast, do not interfere with daily tasks and productivity and require small but cumulative
      changes in posture and LPA throughout the workday.

      Sedentary behavior interventions in the worksite, including those conducted by our team, have
      shown promising effects. Studies that have used multi-level approaches targeting individual,
      social, and environmental factors have been most effective. The most robust environmental
      support has been the use of sit-stand workstations, providing distinct opportunities for
      workers to reduce sitting while maintaining productivity. However, treadmill desks may
      provide an even greater opportunity to both reduce sitting and increase LPA during the
      workday. Thus, a pilot study is required to test the efficacy of this approach to reduce
      sitting and increase LPA in the workplace.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: A within-person, cross-over design will be used. Fifteen participants will take part in two conditions: 1) the treadmill desk: this intervention will ask participants to use a treadmill desk for a minimum of 30min per day for four weeks; and 2) the usual desk condition: participants will use their current workstation, as is, for four weeks. Participants will be randomly assigned to their initial intervention condition after baseline measures have been collected. In addition to the two condition months, there will be a one-week baseline period (to collected information on habitual activity level at work).
primary purpose: Treatment
masking: None (Open Label)
measure: Time spent sitting
time frame: 7-days
description: The change in time spent sitting as measured by the ActivPAL, from baseline to the final week of each intervention condition
measure: Time spent standing
time frame: 7-days
description: The change in time spent standing as measured by the ActivPAL, from baseline to the final week of each intervention condition
measure: Time spent moving
time frame: 7-days
description: The change in time spent moving as measured by the ActivPAL, from baseline to the final week of each intervention condition
measure: Cardiovascular risk: Blood pressure
time frame: 7-days
description: The change in the cardiovascular risk, as measured via blood pressure from baseline to the final week of each condition.
measure: Cardiovascular risk: Body weight
time frame: 7-days
description: The change in the cardiovascular risk, as measured via body weight from baseline to the final week of each condition.
measure: Cardiovascular risk: Percent body fat
time frame: 7-days
description: The change in the cardiovascular risk, as measured via percent body fat from baseline to the final week of each condition.
arm group label: Usual Desk
arm group type: No Intervention
description: participants will work at their usual desk for four weeks.
arm group label: Treadmill desk
arm group type: Experimental
description: Participants will be asked to use a treadmill desk for a minimum of 30 minutes per day for four weeks (Participants will sign up for a total of 30 minutes each day). Additional time may be spent on the treadmill, time permitting (two treadmills will be available to up to 10 people over the four week period).
intervention type: Other
intervention name: Treadmill desk
description: A standing height desk with a treadmill attached.
arm group label: Treadmill desk
other name: ActiveStation Treadmill desks
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Deidentified IPD for all primary and secondary outcome measures will be made available upon request.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data will become available within 6 months of study completion.
ipd access criteria: Data access requests will be reviewed by the Principal Investigator. Requestors will be required to sign a data access agreement.