<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/NCT03233061</url>
  </required_header>
  <id_info>
    <org_study_id>2017001</org_study_id>
    <nct_id>NCT03233061</nct_id>
  </id_info>
  <brief_title>Does Obesity Influence Women Cardiorespiratory Fitness and Daily Physical Activities? (ACTIVOB)</brief_title>
  <acronym>ACTIVOB</acronym>
  <official_title>Does Obesity Influence Women Cardiorespiratory Fitness and Daily Physical Activities?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laboratory of Movement, Condorcet, Tournai, Belgium</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laboratory of Movement, Condorcet, Tournai, Belgium</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>
      Many obese individuals experience difficulties in executing household activities. In this&#xD;
      study, we investigate the cardiorespiratory fitness (CRF) of obese vs. non-obese women, and&#xD;
      the impact of obesity on cardiorespiratory functioning during daily household activities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods: On 48 sedentary female subjects will be assessed by cardiorespiratory exercise&#xD;
      testing with evaluation of peak oxygen uptake (⩒O2), heart rate (HR) and maximal cycling&#xD;
      power output. Next, cardiorespiratory functioning will be assessed during household&#xD;
      activities such as ironing (A1), cleaning floor (A2), walking and climbing stairs (A3).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">July 20, 2017</completion_date>
  <primary_completion_date type="Actual">March 28, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Women OBESE group VS Women NON-OBESE group</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of relative peak oxygen consumption between obese and non-obese women , mesured with indirect calorimetry</measure>
    <time_frame>2 months</time_frame>
    <description>⩒O2 peak comparison between OB vs NO women. For each household activity, the intensity expressed by the ratio ⩒O2 activity/resting ⩒O2 or the ratio ⩒O2 activity /⩒O2 peak will be compared between NO and OB</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>NO</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>NON OBESE WOMEN GROUP ( same age and same physical activities ) cardiorespiratory exercise testing with evaluation of peak oxygen uptake, heart rate and maximal cycling power output. Cardiorespiratory functioning is assessed during household activities such as ironing,cleaning floor,walking and climbing stairs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OBESE GROUP cardiorespiratory exercise testing with evaluation of peak oxygen uptake,heart rate and maximal cycling power output.Cardiorespiratory functioning is assessed during household activities such as ironing, cleaning floor, walking and climbing stairs</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>cardiorespiratory fitness and daily physical activities evaluations</intervention_name>
    <description>The cardiopulmonary exercise testing is performed on a cycle ergometer connected to cardiovascular and respiratory software. Subjects have a facemask, which collected respiratory and metabolic variables.An incremental exercise test is performed up to exhaustion. ⩒O2 is recorded and heart rate is averaged by an electrocardiogram system.&#xD;
Cardiopulmonary exercise testing during household activities Subjects have to perform 3 everyday life household activities: ironing,cleaning floor,walking and climbing stairs.A wearable ambulatory indirect metabolic system is used with Holter mode to record cardiorespiratory measures.Subjects have to breathe through the K4b2 facemask and turbine.</description>
    <arm_group_label>NO</arm_group_label>
    <arm_group_label>OB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index (BMI = weight in kilograms/(height in meters) x (height in meters))&#xD;
             as: healthy obese (OB group (OB); BMI between 30 to 39.9 kg.m-2; n = 20), and healthy&#xD;
             non obese (NO group (NO); BMI between 18.5 to 24.9 kg.m-2; n = 28).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  comorbidities (other than obesity) :&#xD;
&#xD;
               1. history of systemic hypertension or antihypertensive medication, diabetes&#xD;
                  mellitus, cardiovascular or respiratory disease, systemic disease, smoking;&#xD;
&#xD;
               2. any drugs;&#xD;
&#xD;
               3. BMI &gt;40 kg.m-2;&#xD;
&#xD;
               4. having a regular physical activity.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>LAboratoire de l'effort et du mouvement</name>
      <address>
        <city>Tournai</city>
        <state>HAinaut</state>
        <zip>7500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>July 29, 2017</last_update_submitted>
  <last_update_submitted_qc>July 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Laboratory of Movement, Condorcet, Tournai, Belgium</investigator_affiliation>
    <investigator_full_name>Grégory Cuvelier</investigator_full_name>
    <investigator_title>Laboratory Head</investigator_title>
  </responsible_party>
  <keyword>Obesity; cardiorespiratory fitness; oxygen uptake; household activities; physical activity; sedentary; intensity; obese women</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT03233061
org study id: 2017001
nct id: NCT03233061
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Many obese individuals experience difficulties in executing household activities. In this
      study, we investigate the cardiorespiratory fitness (CRF) of obese vs. non-obese women, and
      the impact of obesity on cardiorespiratory functioning during daily household activities.
Methods: On 48 sedentary female subjects will be assessed by cardiorespiratory exercise
      testing with evaluation of peak oxygen uptake (⩒O2), heart rate (HR) and maximal cycling
      power output. Next, cardiorespiratory functioning will be assessed during household
      activities such as ironing (A1), cleaning floor (A2), walking and climbing stairs (A3).
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Women OBESE group VS Women NON-OBESE group
primary purpose: Diagnostic
masking: None (Open Label)
measure: Comparison of relative peak oxygen consumption between obese and non-obese women , mesured with indirect calorimetry
time frame: 2 months
description: ⩒O2 peak comparison between OB vs NO women. For each household activity, the intensity expressed by the ratio ⩒O2 activity/resting ⩒O2 or the ratio ⩒O2 activity /⩒O2 peak will be compared between NO and OB
arm group label: NO
arm group type: Active Comparator
description: NON OBESE WOMEN GROUP ( same age and same physical activities ) cardiorespiratory exercise testing with evaluation of peak oxygen uptake, heart rate and maximal cycling power output. Cardiorespiratory functioning is assessed during household activities such as ironing,cleaning floor,walking and climbing stairs.
arm group label: OB
arm group type: Experimental
description: OBESE GROUP cardiorespiratory exercise testing with evaluation of peak oxygen uptake,heart rate and maximal cycling power output.Cardiorespiratory functioning is assessed during household activities such as ironing, cleaning floor, walking and climbing stairs
intervention type: Diagnostic Test
intervention name: cardiorespiratory fitness and daily physical activities evaluations
description: The cardiopulmonary exercise testing is performed on a cycle ergometer connected to cardiovascular and respiratory software. Subjects have a facemask, which collected respiratory and metabolic variables.An incremental exercise test is performed up to exhaustion. ⩒O2 is recorded and heart rate is averaged by an electrocardiogram system.
Cardiopulmonary exercise testing during household activities Subjects have to perform 3 everyday life household activities: ironing,cleaning floor,walking and climbing stairs.A wearable ambulatory indirect metabolic system is used with Holter mode to record cardiorespiratory measures.Subjects have to breathe through the K4b2 facemask and turbine.
arm group label: NO
arm group label: OB
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Laboratory of Movement, Condorcet, Tournai, Belgium
investigator full name: Grégory Cuvelier
investigator title: Laboratory Head
mesh term: Obesity
sharing ipd: No