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Does Obesity Influence Women Cardiorespiratory Fitness and Daily Physical Activities? (ACTIVOB) (ACTIVOB)

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ClinicalTrials.gov Identifier: NCT03233061
Recruitment Status : Completed
First Posted : July 28, 2017
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Grégory Cuvelier, Laboratory of Movement, Condorcet, Tournai, Belgium

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Diagnostic Test: cardiorespiratory fitness and daily physical activities evaluations Not Applicable

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Women OBESE group VS Women NON-OBESE group
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Does Obesity Influence Women Cardiorespiratory Fitness and Daily Physical Activities?
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : March 28, 2017
Actual Study Completion Date : July 20, 2017

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Arm Intervention/treatment
Active Comparator: NO
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.
Diagnostic Test: cardiorespiratory fitness and daily physical activities evaluations

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.


Experimental: OB
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
Diagnostic Test: cardiorespiratory fitness and daily physical activities evaluations

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.





Primary Outcome Measures :
  1. Comparison of relative peak oxygen consumption between obese and non-obese women , mesured with indirect calorimetry [ Time Frame: 2 months ]
    ⩒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



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI = weight in kilograms/(height in meters) x (height in meters)) as: healthy obese (OB group (OB); BMI between 30 to 39.9 kg.m-2; n = 20), and healthy non obese (NO group (NO); BMI between 18.5 to 24.9 kg.m-2; n = 28).

Exclusion Criteria:

  • comorbidities (other than obesity) :

    1. history of systemic hypertension or antihypertensive medication, diabetes mellitus, cardiovascular or respiratory disease, systemic disease, smoking;
    2. any drugs;
    3. BMI >40 kg.m-2;
    4. having a regular physical activity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233061


Locations
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Belgium
LAboratoire de l'effort et du mouvement
Tournai, HAinaut, Belgium, 7500
Sponsors and Collaborators
Laboratory of Movement, Condorcet, Tournai, Belgium

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Responsible Party: Grégory Cuvelier, Laboratory Head, Laboratory of Movement, Condorcet, Tournai, Belgium
ClinicalTrials.gov Identifier: NCT03233061     History of Changes
Other Study ID Numbers: 2017001
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Grégory Cuvelier, Laboratory of Movement, Condorcet, Tournai, Belgium:
Obesity; cardiorespiratory fitness; oxygen uptake; household activities; physical activity; sedentary; intensity; obese women

Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms