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Influence of Cardio-ventilatory Factors on Exercise Intolerance in Obese Adolescents: Effects of Exercise Training (VENTILOBE)

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Exercise training
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Obesity, Adolescent, Exercise training, Exercise tolerance

Eligibility Criteria

12 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male and female obese adolescents (BMI > IOTF 30, 12-16 years old)

Exclusion Criteria:

  • Cardiovascular pathology
  • Pathology interfering with physical activity (neurological pathology, severe respiratory illness i.e. asthma, renal failure)
  • Diabetes (known or treated)
  • Participation in another study
  • Asthma (known and treated)

Sites / Locations

  • CHU Grenoble

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise training

Arm Description

12-week supervised exercise-training (ET) program consisting of two 60-min and one 120-min exercise sessions per week which focus mainly on aerobic exercises (cycling, treadmill, rower). Initial aerobic exercise intensity is set at 60 % of HR peak and will reach 80 % at the end of the ET protocol.

Outcomes

Primary Outcome Measures

Exercise tolerance (Expiratory flow limitation and Operational Lung Volumes at rest and exercise, cardiorespiratory and subjective responses to incremental exercise)

Secondary Outcome Measures

Polysomnography
Explore the potential existence of obstructive sleep apnea and its effects on cardiovascular adaptations during exercise.
Cardiorespiratory fitness (VO2max)

Full Information

First Posted
July 29, 2011
Last Updated
June 26, 2012
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT01411605
Brief Title
Influence of Cardio-ventilatory Factors on Exercise Intolerance in Obese Adolescents: Effects of Exercise Training
Acronym
VENTILOBE
Official Title
Influence of Cardio-ventilatory Factors on Exercise Intolerance in Obese Adolescents: Effects of Exercise Training
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Worldwide, childhood and adolescent obesity has reached epidemic proportions despite major efforts to promote weight reduction. Pediatric obesity commonly presages adult obesity and is associated with the development of weight-related comorbid conditions and increased morbidity. Regular physical activity is an important modality of obesity management. Despite controversies, poor exercise tolerance has frequently been reported in youth obesity and the cause of this limited exercise tolerance remains unknown. Several factors accompanying obesity may interfere with exercise tolerance in obese populations. Respiratory factors, such as decreased thoracic compliance, increased airway resistance and breathing at low pulmonary volumes are associated with obesity and may impact exercise intolerance in this population. Moreover, even in people with otherwise normal lungs, the normal ventilatory responses to exercise can become constrained in obesity. A thorough understanding of the mechanisms underlying this exercise intolerance remains fundamental in order to favour long term adherence to exercise training. This is especially true in youth populations, in which the management of overweight and obesity must be undertaken as soon as possible, due to the early onset of cardiovascular risk factors. The main purpose of this study is to determine early-onset cardio-respiratory mortality factors in obese adolescents as well as their relation with exercise intolerance (i.e. dyspnea) when compared with age and gender-paired normal-weight volunteers.
Detailed Description
Physiopathological trial. Expected total enrollment : 20 obese adolescents + 20 control subjects Tested treatment: Exercise training (4 hours per week). Treatment duration: 12 weeks

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Adolescent, Exercise training, Exercise tolerance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise training
Arm Type
Experimental
Arm Description
12-week supervised exercise-training (ET) program consisting of two 60-min and one 120-min exercise sessions per week which focus mainly on aerobic exercises (cycling, treadmill, rower). Initial aerobic exercise intensity is set at 60 % of HR peak and will reach 80 % at the end of the ET protocol.
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
12-week supervised exercise-training (ET) program consisting of two 60-min and one 120-min exercise sessions per week which focus mainly on aerobic exercises (cycling, treadmill, rower). Initial aerobic exercise intensity is set at 60 % of HR peak and will reach 80 % at the end of the ET protocol.
Primary Outcome Measure Information:
Title
Exercise tolerance (Expiratory flow limitation and Operational Lung Volumes at rest and exercise, cardiorespiratory and subjective responses to incremental exercise)
Time Frame
Participants will be followed for the duration of exercise training, an expected average of 12 weeks
Secondary Outcome Measure Information:
Title
Polysomnography
Description
Explore the potential existence of obstructive sleep apnea and its effects on cardiovascular adaptations during exercise.
Time Frame
Participants will be followed for the duration of exercise training, an expected average of 12 weeks
Title
Cardiorespiratory fitness (VO2max)
Time Frame
Participants will be followed for the duration of exercise training, an expected average of 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female obese adolescents (BMI > IOTF 30, 12-16 years old) Exclusion Criteria: Cardiovascular pathology Pathology interfering with physical activity (neurological pathology, severe respiratory illness i.e. asthma, renal failure) Diabetes (known or treated) Participation in another study Asthma (known and treated)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard WUYAM, Dr
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claudine Perrin, MD
Organizational Affiliation
CHU Grenoble, Pediatrics Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38000
Country
France

12. IPD Sharing Statement

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Influence of Cardio-ventilatory Factors on Exercise Intolerance in Obese Adolescents: Effects of Exercise Training

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