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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03233061
Other study ID # 2017001
Secondary ID
Status Completed
Phase N/A
First received July 26, 2017
Last updated July 29, 2017
Start date March 1, 2017
Est. completion date July 20, 2017

Study information

Verified date July 2017
Source Laboratory of Movement, Condorcet, Tournai, Belgium
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date July 20, 2017
Est. primary completion date March 28, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Belgium LAboratoire de l'effort et du mouvement Tournai HAinaut

Sponsors (1)

Lead Sponsor Collaborator
Laboratory of Movement, Condorcet, Tournai, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 2 months
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