NCT03233061

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

27 days

First QC Date

July 26, 2017

Last Update Submit

July 29, 2017

Conditions

Keywords

Obesity; cardiorespiratory fitness; oxygen uptake; household activities; physical activity; sedentary; intensity; obese women

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

NO

ACTIVE COMPARATOR

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

OB

EXPERIMENTAL

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

Interventions

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.

NOOB

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LAboratoire de l'effort et du mouvement

Tournai, HAinaut, 7500, Belgium

Location

MeSH Terms

Conditions

ObesityMotor ActivitySedentary Behavior

Interventions

Cardiorespiratory Fitness

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Physical FitnessMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealthPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Women OBESE group VS Women NON-OBESE group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Laboratory Head

Study Record Dates

First Submitted

July 26, 2017

First Posted

July 28, 2017

Study Start

March 1, 2017

Primary Completion

March 28, 2017

Study Completion

July 20, 2017

Last Updated

August 1, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations