<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/NCT03307473</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-354</org_study_id>
    <nct_id>NCT03307473</nct_id>
  </id_info>
  <brief_title>Physical Activity and Sedentary Behaviour Associated With Utilitarian E-bike Use</brief_title>
  <acronym>VELONAPS</acronym>
  <official_title>Total Physical Activity and Sedentary Behaviour Changes Associated With Regular Daily Life Utilitarian E-bike Use : VELONAPS Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ONAPS : Observatoire National de l'Activité Physique et de la Sédentarité</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Physical inactivity and sedentary are recognized as important risks factors for several&#xD;
      diseases and total mortality. One of the main perceived barriers to physical activity is the&#xD;
      lack of time and motivation. Active commuting during daily routine could overcome these&#xD;
      barriers and e-bikes appears to be a promising and practical tool to meet physical activity&#xD;
      guidelines.&#xD;
&#xD;
      E-bikes are a physically active transportation mode, with a riding intensity contributing to&#xD;
      activities in the moderate-intensity range (3-6 METs) for any of the assistance mode.&#xD;
      Electric assistance is provided only when a rider is pedaling. The study VELONAPS mainly aims&#xD;
      at investigating if real-life usage of utilitarian e-bike is associated with significant&#xD;
      changes on total physical activity and sedentary patterns. During up to 4 months of free use&#xD;
      of an e-bike, our purpose is to quantify its usage along with total physical activity and&#xD;
      sedentary levels. We hypothesize that using an e-bike for commuting increase the total&#xD;
      physical activity of at least 7.5 MET-h/week, increasing as well adherence to physical&#xD;
      activity guidelines.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During 3 months in a the geographic area of Clermont-Ferrand (France), new e-bike buyers and&#xD;
      renters are invited to take part in VELONAPS study before starting to use their e-bike. The&#xD;
      sample is constituted of willing participants who plan to use their e-bike, at least in part,&#xD;
      for work-related and commuter trips. Each participant will be followed during 4 months, with&#xD;
      4 study points.&#xD;
&#xD;
      At T0, subjects are invited for the baseline visit including a medical interview and physical&#xD;
      examination (with anthropometric measurements), and a physical stress test evaluating aerobic&#xD;
      fitness (submaximal step-test). Online questionnaires are provided to measure physical&#xD;
      activity and sedentary patterns (RPAQ), motivations and barriers to physical activity (EMAPS&#xD;
      and BPAQ), perceived health and quality of life (SF-12), perceived exertion for common&#xD;
      physical efforts (Borg scale).&#xD;
&#xD;
      At T1 and T2 (respectively one and two months after having started e-bike use), the&#xD;
      questionnaire measuring physical activity and sedentary patterns of the past month is&#xD;
      requested again.&#xD;
&#xD;
      At T4 (final study point, after 4 months of e-bike use), subjects are invited for the&#xD;
      follow-up visit including anthropometric measurements and a physical stress test evaluating&#xD;
      aerobic fitness. Online questionnaires are provided to measure the same dimensions than at&#xD;
      the T0 study point.&#xD;
&#xD;
      The primary endpoint of the study is to compare the physical activity level at T0 and the one&#xD;
      at T4.&#xD;
&#xD;
      Secondary endpoints are the modifications (comparisons between T0 and T4) in :&#xD;
&#xD;
        -  sedentary levels.&#xD;
&#xD;
        -  the percent of individuals meeting the physical activity guidelines.&#xD;
&#xD;
        -  motivations and barriers to physical activity.&#xD;
&#xD;
        -  perceived health and quality of life.&#xD;
&#xD;
        -  perceived exertion for common physical efforts.&#xD;
&#xD;
        -  anthropometric measurements (BMI and waist size). Subgroup analyses will identify either&#xD;
           consistency of, of large differences, in the magnitude of e-bike use effect among&#xD;
           different categories of participants: by age, by sex, by initial physical condition, and&#xD;
           by initial total physical activity level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Anticipated">May 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Total physical activity</measure>
    <time_frame>at 4 months</time_frame>
    <description>the amount of total physical activity engaged in each week (in MET-h/week).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sedentary time</measure>
    <time_frame>at 4 months</time_frame>
    <description>Total of time while sitting, lying down, and expending very little energy (approximately 1.0-1.5 metabolic equivalents [METs]) in each day (in h/day).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical condition</measure>
    <time_frame>at 4 months</time_frame>
    <description>Estimated aerobic fitness (in METs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise motivations questionnaire</measure>
    <time_frame>at 4 months</time_frame>
    <description>factor structure examination of the Behavioural Regulation in exercise questionnaire-2 (BREQ-2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life questionnaire</measure>
    <time_frame>at 4 months</time_frame>
    <description>Assessment of health related quality of life using SF-12 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>at 4 months</time_frame>
    <description>Body weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist size</measure>
    <time_frame>at 4 months</time_frame>
    <description>Waist size measurement (between the last/lowest rib, and the hip bone)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived exertion</measure>
    <time_frame>at 4 months</time_frame>
    <description>Rating of perceived exertion for common physical stresses.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">54</enrollment>
  <condition>All-comers</condition>
  <arm_group>
    <arm_group_label>e-bike</arm_group_label>
    <description>During 3 months in a the geographic area of Clermont-Ferrand (France), new e-bike buyers and renters are invited to take part in VELONAPS study before starting to use their e-bike</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>E6BIKE</intervention_name>
    <description>During 3 months in a the geographic area of Clermont-Ferrand (France), new e-bike buyers and renters are invited to take part in VELONAPS study before starting to use their e-bike</description>
    <arm_group_label>e-bike</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        new e-bikes user&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  being a new e-bikes user&#xD;
&#xD;
          -  planning to use the e-bikes, at least in part, for work-related and commuter trips&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having used regularly (more than once a week) an e-bike for at least one month during&#xD;
             the last three months&#xD;
&#xD;
          -  e-bike use already started for more than a week&#xD;
&#xD;
          -  e-bike use only for leisure activities (no commuting)&#xD;
&#xD;
          -  health condition(s) contraindicating a fitness test&#xD;
&#xD;
          -  being pregnant&#xD;
&#xD;
          -  not having access to the e-bike for a long period (&gt; 1 month) during the follow-up&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martine DUCLOS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick LACARIN</last_name>
    <phone>04 73 75 11 95</phone>
    <email>placarin@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick LACARIN</last_name>
      <phone>04 73 75 11 95</phone>
      <email>placarin@chu-clermontferrand.fr</email>
    </contact>
    <investigator>
      <last_name>Martine DUCLOS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physical activity</keyword>
  <keyword>Bicycling</keyword>
  <keyword>Transportation</keyword>
  <keyword>Public health</keyword>
  <!-- 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/NCT03307473
org study id: CHU-354
nct id: NCT03307473
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Physical inactivity and sedentary are recognized as important risks factors for several
      diseases and total mortality. One of the main perceived barriers to physical activity is the
      lack of time and motivation. Active commuting during daily routine could overcome these
      barriers and e-bikes appears to be a promising and practical tool to meet physical activity
      guidelines.

      E-bikes are a physically active transportation mode, with a riding intensity contributing to
      activities in the moderate-intensity range (3-6 METs) for any of the assistance mode.
      Electric assistance is provided only when a rider is pedaling. The study VELONAPS mainly aims
      at investigating if real-life usage of utilitarian e-bike is associated with significant
      changes on total physical activity and sedentary patterns. During up to 4 months of free use
      of an e-bike, our purpose is to quantify its usage along with total physical activity and
      sedentary levels. We hypothesize that using an e-bike for commuting increase the total
      physical activity of at least 7.5 MET-h/week, increasing as well adherence to physical
      activity guidelines.
During 3 months in a the geographic area of Clermont-Ferrand (France), new e-bike buyers and
      renters are invited to take part in VELONAPS study before starting to use their e-bike. The
      sample is constituted of willing participants who plan to use their e-bike, at least in part,
      for work-related and commuter trips. Each participant will be followed during 4 months, with
      4 study points.

      At T0, subjects are invited for the baseline visit including a medical interview and physical
      examination (with anthropometric measurements), and a physical stress test evaluating aerobic
      fitness (submaximal step-test). Online questionnaires are provided to measure physical
      activity and sedentary patterns (RPAQ), motivations and barriers to physical activity (EMAPS
      and BPAQ), perceived health and quality of life (SF-12), perceived exertion for common
      physical efforts (Borg scale).

      At T1 and T2 (respectively one and two months after having started e-bike use), the
      questionnaire measuring physical activity and sedentary patterns of the past month is
      requested again.

      At T4 (final study point, after 4 months of e-bike use), subjects are invited for the
      follow-up visit including anthropometric measurements and a physical stress test evaluating
      aerobic fitness. Online questionnaires are provided to measure the same dimensions than at
      the T0 study point.

      The primary endpoint of the study is to compare the physical activity level at T0 and the one
      at T4.

      Secondary endpoints are the modifications (comparisons between T0 and T4) in :

        -  sedentary levels.

        -  the percent of individuals meeting the physical activity guidelines.

        -  motivations and barriers to physical activity.

        -  perceived health and quality of life.

        -  perceived exertion for common physical efforts.

        -  anthropometric measurements (BMI and waist size). Subgroup analyses will identify either
           consistency of, of large differences, in the magnitude of e-bike use effect among
           different categories of participants: by age, by sex, by initial physical condition, and
           by initial total physical activity level.
observational model: Cohort
time perspective: Prospective
measure: Total physical activity
time frame: at 4 months
description: the amount of total physical activity engaged in each week (in MET-h/week).
measure: Sedentary time
time frame: at 4 months
description: Total of time while sitting, lying down, and expending very little energy (approximately 1.0-1.5 metabolic equivalents [METs]) in each day (in h/day).
measure: Physical condition
time frame: at 4 months
description: Estimated aerobic fitness (in METs)
measure: Exercise motivations questionnaire
time frame: at 4 months
description: factor structure examination of the Behavioural Regulation in exercise questionnaire-2 (BREQ-2)
measure: Quality of life questionnaire
time frame: at 4 months
description: Assessment of health related quality of life using SF-12 questionnaire
measure: Weight
time frame: at 4 months
description: Body weight
measure: Waist size
time frame: at 4 months
description: Waist size measurement (between the last/lowest rib, and the hip bone)
measure: Perceived exertion
time frame: at 4 months
description: Rating of perceived exertion for common physical stresses.
arm group label: e-bike
description: During 3 months in a the geographic area of Clermont-Ferrand (France), new e-bike buyers and renters are invited to take part in VELONAPS study before starting to use their e-bike
intervention type: Behavioral
intervention name: E6BIKE
description: During 3 months in a the geographic area of Clermont-Ferrand (France), new e-bike buyers and renters are invited to take part in VELONAPS study before starting to use their e-bike
arm group label: e-bike
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Martine DUCLOS
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: Patrick LACARIN
phone: 04 73 75 11 95
email: placarin@chu-clermontferrand.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor