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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
cardiorespiratory fitness and daily physical activities evaluations
Sponsored by
Laboratory of Movement, Condorcet, Tournai, Belgium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obesity focused on measuring Obesity; cardiorespiratory fitness; oxygen uptake; household activities; physical activity; sedentary; intensity; obese women

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • LAboratoire de l'effort et du mouvement

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

NO

OB

Arm 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.

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

Outcomes

Primary Outcome Measures

Comparison of relative peak oxygen consumption between obese and non-obese women , mesured with indirect calorimetry
⩒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

Secondary Outcome Measures

Full Information

First Posted
July 26, 2017
Last Updated
July 29, 2017
Sponsor
Laboratory of Movement, Condorcet, Tournai, Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT03233061
Brief Title
Does Obesity Influence Women Cardiorespiratory Fitness and Daily Physical Activities? (ACTIVOB)
Acronym
ACTIVOB
Official Title
Does Obesity Influence Women Cardiorespiratory Fitness and Daily Physical Activities?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 28, 2017 (Actual)
Study Completion Date
July 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laboratory of Movement, Condorcet, Tournai, Belgium

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity; cardiorespiratory fitness; oxygen uptake; household activities; physical activity; sedentary; intensity; obese women

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Women OBESE group VS Women NON-OBESE group
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NO
Arm Type
Active Comparator
Arm 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 Title
OB
Arm Type
Experimental
Arm 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(s)
cardiorespiratory fitness and daily physical activities evaluations
Intervention 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.
Primary Outcome Measure Information:
Title
Comparison of relative peak oxygen consumption between obese and non-obese women , mesured with indirect calorimetry
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
Time Frame
2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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) : history of systemic hypertension or antihypertensive medication, diabetes mellitus, cardiovascular or respiratory disease, systemic disease, smoking; any drugs; BMI >40 kg.m-2; having a regular physical activity.
Facility Information:
Facility Name
LAboratoire de l'effort et du mouvement
City
Tournai
State/Province
HAinaut
ZIP/Postal Code
7500
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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

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