<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/NCT03273361</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00001535</org_study_id>
    <nct_id>NCT03273361</nct_id>
  </id_info>
  <brief_title>Desk Cycling Work Performance Evaluation</brief_title>
  <official_title>Desk-Compatible Elliptical Device: Feasibility Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Milton S. Hershey Medical Center</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>
      This lab study is evaluating the feasibility of accomplishing productive office work while&#xD;
      simultaneously pedaling a compact desk-based cycling device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2016</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Subjects were randomly assigned to a pedaling sequence based on the Graeco Latin squares design. They were blinded regarding which pedaling sequence they were assigned to.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Typing task</measure>
    <time_frame>5 minutes</time_frame>
    <description>Participants completed a computerized typing task</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reading task</measure>
    <time_frame>5 minutes</time_frame>
    <description>Participants read a brief passage and answered questions to assess reading comprehension.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Logic Reasoning and Phone Task</measure>
    <time_frame>5 minutes</time_frame>
    <description>Participants completed logical reasoning questions while answering a simulated phone call.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Obesity</condition>
  <condition>Physical Activity</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Seated</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants completed work tasks while seated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Intensity Pedaling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants completed work tasks while pedaling at a low intensity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-Moderate Intensity Pedaling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants completed work tasks while pedaling at a low-moderate intensity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Compact Cycling Device</intervention_name>
    <description>Participants pedaled a compact cycling device while simultaneously working at a desk.</description>
    <arm_group_label>Low Intensity Pedaling</arm_group_label>
    <arm_group_label>Low-Moderate Intensity Pedaling</arm_group_label>
    <arm_group_label>Seated</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-65 years&#xD;
&#xD;
          -  Ability to type without looking at the keyboard&#xD;
&#xD;
          -  Native English speaker&#xD;
&#xD;
          -  Normal hearing&#xD;
&#xD;
          -  Spend 6 or more hours per day sitting&#xD;
&#xD;
          -  Less than 150 minutes of physical activity per week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive response on the Physical Activity Readiness Questionnaire indicating that low&#xD;
             intensity pedaling could present safety risks&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Body mass index less than 18 or greater than 35&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liza Rovniak, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pennsylvania State University College of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andris Freivalds, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Penn State University</affiliation>
  </overall_official>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>March 20, 2018</last_update_submitted>
  <last_update_submitted_qc>March 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Liza Rovniak</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</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/NCT03273361
org study id: STUDY00001535
nct id: NCT03273361
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This lab study is evaluating the feasibility of accomplishing productive office work while
      simultaneously pedaling a compact desk-based cycling device.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
masking description: Subjects were randomly assigned to a pedaling sequence based on the Graeco Latin squares design. They were blinded regarding which pedaling sequence they were assigned to.
measure: Typing task
time frame: 5 minutes
description: Participants completed a computerized typing task
measure: Reading task
time frame: 5 minutes
description: Participants read a brief passage and answered questions to assess reading comprehension.
measure: Logic Reasoning and Phone Task
time frame: 5 minutes
description: Participants completed logical reasoning questions while answering a simulated phone call.
arm group label: Seated
arm group type: Experimental
description: Participants completed work tasks while seated.
arm group label: Low Intensity Pedaling
arm group type: Experimental
description: Participants completed work tasks while pedaling at a low intensity.
arm group label: Low-Moderate Intensity Pedaling
arm group type: Experimental
description: Participants completed work tasks while pedaling at a low-moderate intensity.
intervention type: Behavioral
intervention name: Compact Cycling Device
description: Participants pedaled a compact cycling device while simultaneously working at a desk.
arm group label: Low Intensity Pedaling
arm group label: Low-Moderate Intensity Pedaling
arm group label: Seated
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Liza Rovniak, PhD, MPH
role: Principal Investigator
affiliation: Pennsylvania State University College of Medicine
last name: Andris Freivalds, PhD
role: Study Director
affiliation: Penn State University
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Liza Rovniak
investigator title: Associate Professor
mesh term: Overweight
sharing ipd: No