<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/NCT03235583</url>
  </required_header>
  <id_info>
    <org_study_id>2011.702</org_study_id>
    <nct_id>NCT03235583</nct_id>
  </id_info>
  <brief_title>MOTIONPODTM Validation in Free-living Conditio</brief_title>
  <official_title>Validation of MotionPODTM a Device for Measuring Physical Activity, in Free-living Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      In this study, the investigators propose to assess the validity in measuring physical&#xD;
      activity (PA) of a new PA monitor system the MOTIONPODTM, that coupled a hip-worn&#xD;
      multi-sensor device (associating a tri-axial accelerometer, a magnetometer and a gyroscope)&#xD;
      with an automatic activity/posture recognition algorithm and an activity-specific multilinear&#xD;
      prediction model. The MOTIONPODTM performances in predicting mean daily PA energy expenditure&#xD;
      (PAEE) will be calculated against the reference PAEE gold standard measure, using the doubly&#xD;
      labeled water method (DLW). The MOTIONPODTM performances in predicting PAEE and PA patterns&#xD;
      will be compared to those of two existing activity or movement monitors: the triaxial&#xD;
      accelerometer ActigraphGT3X+TM and a device combining cardiofrequencemetry with&#xD;
      accelerometry, the ActiheartTM. This latter has demonstrated fair performances but at the&#xD;
      cost of a calibration of the heart-rate/EE relationship that limits its use in large&#xD;
      population samples. Briefly, this open study will include 120 subjects, aged 18 to 75 years&#xD;
      of both gender and with broad range of body mass index and physical activity level. The&#xD;
      subjects will carry a MOTIONPODTM, an ActigraphGT3X+TM, an ActiheartTM and a GPS for a total&#xD;
      of 14 days in everyday life conditions and complete a physical activity diary. In half of the&#xD;
      subjects, PA will be evaluated on a period of 14 days, with standard PAEE measured by DLW.&#xD;
      The other 60 subjects will be studied twice, one month apart, to test the reproducibility of&#xD;
      the measures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2, 2012</start_date>
  <completion_date type="Actual">October 11, 2013</completion_date>
  <primary_completion_date type="Actual">October 11, 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Daily physical activity energy expenditure (PAEE) MOTIONPODTM prediction</measure>
    <time_frame>PAEE measurement will be measured over the 14-day study-period (Modality A) or the two 8-day periods (Modality B)</time_frame>
    <description>MotionPodTM predictions will be calculated with the newly developed algorithms to evaluate the concordance between the physical activity energy expenditure (PAEE) estimated by the MOTIONPODTM and that of 2 physical activity monitors: the Actigraph GT3X+TM and the ActiheartTM. The estimation of PAEE by MotionPodTM will be compared with the measure of PAEE by DLW (gold standard measure, primary outcome 2/), with the measure of PAEE by Actiheart TM (primary outcome 3/), and with the measure of PAEE by ActigraphGT3X+ TM (primary outcome 4/).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Daily physical activity energy expenditure (PAEE) using DLW (gold standard measure) (modality A)</measure>
    <time_frame>PAEE measurement will be measured over the 14-day study-period (Modality A)</time_frame>
    <description>Daily Total Energy Expenditure (TEE) and PAEE standards will be measured with the DLW reference method. Briefly Resting metabolic Rate (RMR) will be measured via indirect calorimetry using a ventilated open-hood metabolic cart after a 12h-overnight fast. TEE will be determined using a 14-day multipoint DLW protocol. After providing a baseline urine sample, subjects will ingest a premixed dose of H218O (10% enriched) and 2H2O (99.85% enriched) DLW. Equilibration will be assessed in urine samples collected at 4h and 5h post dose. Subsequent urine samples will be collected every two days of the 14 days of the protocol. 2H2 and 18O isotopic enrichment will be analyzed in quadruplicate by pyrolysis on an elemental analyzer (Flash HT; ThermoFisher) interfaced with an IRMS (Delta V, ThermoFisher).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Daily physical activity energy expenditure (PAEE) Actiheart TM estimates (modalities A &amp; B)</measure>
    <time_frame>PAEE measurement will be measured over the 14-day study-period (Modality A) or the two 8-day periods (Modality B)</time_frame>
    <description>ActiheartTM PAEE predictions will be calculated using the Actiheart software.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Daily physical activity energy expenditure (PAEE) ActigraphGT3X+ TM estimates (modalities A &amp; B)</measure>
    <time_frame>PAEE measurement will be measured over the 14-day study-period (Modality A) or the two 8-day periods (Modality B)</time_frame>
    <description>ActigraphGT3X+TM PAEE predictions will be calculated using the ActigraphGT3X+ TM software.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification and classification of activity/posture patterns by the MOTIONPODTM device (assessed by confusion matrices)</measure>
    <time_frame>PAEE activity patterns will be evaluated over the 14-day study-period (Modality A) or over the two 8-day periods (Modality B)</time_frame>
    <description>Different activities corresponding to the activity/recognition algorithm will be identified and quantified using the activity diary. The recognition rate of activity typologies (lying, sitting, inactive standing, active standing, walking, biking) by the MOTIONPODTM will be compared to data of the physical activity diary (measures (secondary measure outcome 2/). Confusion matrices will be used to compare the diary measures (secondary measure outcome 2/) with the MOTIONPODTM outputs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification and classification of activities/postures patterns collected in the activity diary</measure>
    <time_frame>PAEE activity patterns will be evaluated over the 14-day study-period (Modality A) or over the two 8-day periods (Modality B)</time_frame>
    <description>Different activities corresponding to the activity/recognition algorithm will be identified and quantified using the activity diary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>(BMI &lt; or &gt; 30 kg/m2).</measure>
    <time_frame>Baseline (at inclusion)</time_frame>
    <description>to evaluate de concordance of MOTIONPODTM predictions with standard measure according to activity level, as previously described by subgroups</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Obese</condition>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>MotionPod Validation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Medical device validation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MOTIONPODTM device validation</intervention_name>
    <description>MOTIONPODTM validation in free-living conditions using gold standards, including the DLW method</description>
    <arm_group_label>MotionPod Validation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects&#xD;
&#xD;
          -  Age : 18 to 75 years&#xD;
&#xD;
          -  Patients or healthy volunteers&#xD;
&#xD;
          -  40 obese subjects (BMI ≥ 30 kg/m2), 40 non-obese (BMI &lt;30 kg/m2) and active (PA level&#xD;
             evaluated by the RPAQ questionnaire) subjects, 40 non-obese and sedentary subjects&#xD;
&#xD;
          -  Absence of cardiac rate disorders&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with acute disorders: cardiovascular or neoplastic, severe infection during 3&#xD;
             previous months&#xD;
&#xD;
          -  Subjects with a pathology restricting the walking distance (confinement, distance &lt;200&#xD;
             meters)&#xD;
&#xD;
          -  Subjects with implants (Pacemaker, cardiac implant or another active implant)&#xD;
&#xD;
          -  Claustrophobic subjects (for subjects participating to &quot;doubly labelled water&quot;&#xD;
             protocol)&#xD;
&#xD;
          -  Drug use that could affect energy expenditure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre de Recherche en Nutrition Humaine Rhône-Alpes - Centre hospitalier Lyon Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69310</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Energy expenditure</keyword>
  <keyword>physical activity</keyword>
  <keyword>accelerometer</keyword>
  <keyword>magnetometer</keyword>
  <keyword>monitoring</keyword>
  <keyword>free-living conditions</keyword>
  <keyword>doubly labelled water</keyword>
  <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/NCT03235583
org study id: 2011.702
nct id: NCT03235583
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, the investigators propose to assess the validity in measuring physical
      activity (PA) of a new PA monitor system the MOTIONPODTM, that coupled a hip-worn
      multi-sensor device (associating a tri-axial accelerometer, a magnetometer and a gyroscope)
      with an automatic activity/posture recognition algorithm and an activity-specific multilinear
      prediction model. The MOTIONPODTM performances in predicting mean daily PA energy expenditure
      (PAEE) will be calculated against the reference PAEE gold standard measure, using the doubly
      labeled water method (DLW). The MOTIONPODTM performances in predicting PAEE and PA patterns
      will be compared to those of two existing activity or movement monitors: the triaxial
      accelerometer ActigraphGT3X+TM and a device combining cardiofrequencemetry with
      accelerometry, the ActiheartTM. This latter has demonstrated fair performances but at the
      cost of a calibration of the heart-rate/EE relationship that limits its use in large
      population samples. Briefly, this open study will include 120 subjects, aged 18 to 75 years
      of both gender and with broad range of body mass index and physical activity level. The
      subjects will carry a MOTIONPODTM, an ActigraphGT3X+TM, an ActiheartTM and a GPS for a total
      of 14 days in everyday life conditions and complete a physical activity diary. In half of the
      subjects, PA will be evaluated on a period of 14 days, with standard PAEE measured by DLW.
      The other 60 subjects will be studied twice, one month apart, to test the reproducibility of
      the measures.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Daily physical activity energy expenditure (PAEE) MOTIONPODTM prediction
time frame: PAEE measurement will be measured over the 14-day study-period (Modality A) or the two 8-day periods (Modality B)
description: MotionPodTM predictions will be calculated with the newly developed algorithms to evaluate the concordance between the physical activity energy expenditure (PAEE) estimated by the MOTIONPODTM and that of 2 physical activity monitors: the Actigraph GT3X+TM and the ActiheartTM. The estimation of PAEE by MotionPodTM will be compared with the measure of PAEE by DLW (gold standard measure, primary outcome 2/), with the measure of PAEE by Actiheart TM (primary outcome 3/), and with the measure of PAEE by ActigraphGT3X+ TM (primary outcome 4/).
measure: Daily physical activity energy expenditure (PAEE) using DLW (gold standard measure) (modality A)
time frame: PAEE measurement will be measured over the 14-day study-period (Modality A)
description: Daily Total Energy Expenditure (TEE) and PAEE standards will be measured with the DLW reference method. Briefly Resting metabolic Rate (RMR) will be measured via indirect calorimetry using a ventilated open-hood metabolic cart after a 12h-overnight fast. TEE will be determined using a 14-day multipoint DLW protocol. After providing a baseline urine sample, subjects will ingest a premixed dose of H218O (10% enriched) and 2H2O (99.85% enriched) DLW. Equilibration will be assessed in urine samples collected at 4h and 5h post dose. Subsequent urine samples will be collected every two days of the 14 days of the protocol. 2H2 and 18O isotopic enrichment will be analyzed in quadruplicate by pyrolysis on an elemental analyzer (Flash HT; ThermoFisher) interfaced with an IRMS (Delta V, ThermoFisher).
measure: Daily physical activity energy expenditure (PAEE) Actiheart TM estimates (modalities A & B)
time frame: PAEE measurement will be measured over the 14-day study-period (Modality A) or the two 8-day periods (Modality B)
description: ActiheartTM PAEE predictions will be calculated using the Actiheart software.
measure: Daily physical activity energy expenditure (PAEE) ActigraphGT3X+ TM estimates (modalities A & B)
time frame: PAEE measurement will be measured over the 14-day study-period (Modality A) or the two 8-day periods (Modality B)
description: ActigraphGT3X+TM PAEE predictions will be calculated using the ActigraphGT3X+ TM software.
measure: Identification and classification of activity/posture patterns by the MOTIONPODTM device (assessed by confusion matrices)
time frame: PAEE activity patterns will be evaluated over the 14-day study-period (Modality A) or over the two 8-day periods (Modality B)
description: Different activities corresponding to the activity/recognition algorithm will be identified and quantified using the activity diary. The recognition rate of activity typologies (lying, sitting, inactive standing, active standing, walking, biking) by the MOTIONPODTM will be compared to data of the physical activity diary (measures (secondary measure outcome 2/). Confusion matrices will be used to compare the diary measures (secondary measure outcome 2/) with the MOTIONPODTM outputs.
measure: Identification and classification of activities/postures patterns collected in the activity diary
time frame: PAEE activity patterns will be evaluated over the 14-day study-period (Modality A) or over the two 8-day periods (Modality B)
description: Different activities corresponding to the activity/recognition algorithm will be identified and quantified using the activity diary.
measure: (BMI < or > 30 kg/m2).
time frame: Baseline (at inclusion)
description: to evaluate de concordance of MOTIONPODTM predictions with standard measure according to activity level, as previously described by subgroups
arm group label: MotionPod Validation
arm group type: Other
description: Medical device validation
intervention type: Device
intervention name: MOTIONPODTM device validation
description: MOTIONPODTM validation in free-living conditions using gold standards, including the DLW method
arm group label: MotionPod Validation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No