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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01411605
First received: July 29, 2011
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Exercise training

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Influence of Cardio-ventilatory Factors on Exercise Intolerance in Obese Adolescents: Effects of Exercise Training

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Polysomnography [ Time Frame: Participants will be followed for the duration of exercise training, an expected average of 12 weeks ] [ Designated as safety issue: No ]
    Explore the potential existence of obstructive sleep apnea and its effects on cardiovascular adaptations during exercise.

  • Cardiorespiratory fitness (VO2max) [ Time Frame: Participants will be followed for the duration of exercise training, an expected average of 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2007
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise training

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.

Behavioral: Exercise training

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.

Other Name: Exercise training

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

Ages Eligible for Study:   12 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411605

Locations
France
CHU Grenoble
Grenoble, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Bernard WUYAM, Dr CHU GRENOBLE
Principal Investigator: Claudine Perrin, MD CHU Grenoble, Pediatrics Department
  More Information

No publications provided

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01411605     History of Changes
Other Study ID Numbers: 0718, 2007-A00714-49
Study First Received: July 29, 2011
Last Updated: June 26, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
Obesity
Adolescent
Exercise training
Exercise tolerance

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 02, 2014