Clinical trial NCT01411605: Influence of Cardio-ventilatory Factors on Exercise Intolerance in Obese Adolescents: Effects of Exercise Training
Official title: Influence of Cardio-ventilatory Factors on Exercise Intolerance in Obese Adolescents: Effects of Exercise Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Adolescent
Exercise training
Exercise tolerance
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2011-08-08
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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)

Primary outcomes:
measure: Exercise tolerance (Expiratory flow limitation and Operational Lung Volumes at rest and exercise, cardiorespiratory and subjective responses to incremental exercise)
timeFrame: Participants will be followed for the duration of exercise training, an expected average of 12 weeks
Secondary outcomes:
measure: Polysomnography
timeFrame: Participants will be followed for the duration of exercise training, an expected average of 12 weeks
measure: Cardiorespiratory fitness (VO2max)
timeFrame: Participants will be followed for the duration of exercise training, an expected average of 12 weeks
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Bernard WUYAM, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Grenoble, Pediatrics Department
name: Claudine Perrin, MD
role: PRINCIPAL_INVESTIGATOR
References: