Influence of Cardio-ventilatory Factors on Exercise Intolerance in Obese Adolescents: Effects of Exercise Training
VENTILOBE
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Sep 2007
Longer than P75 for not_applicable obesity
1 active site
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
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 29, 2011
CompletedFirst Posted
Study publicly available on registry
August 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedJune 28, 2012
June 1, 2012
4.5 years
July 29, 2011
June 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Exercise tolerance (Expiratory flow limitation and Operational Lung Volumes at rest and exercise, cardiorespiratory and subjective responses to incremental exercise)
Participants will be followed for the duration of exercise training, an expected average of 12 weeks
Secondary Outcomes (2)
Polysomnography
Participants will be followed for the duration of exercise training, an expected average of 12 weeks
Cardiorespiratory fitness (VO2max)
Participants will be followed for the duration of exercise training, an expected average of 12 weeks
Study Arms (1)
Exercise training
EXPERIMENTAL12-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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Male and female obese adolescents (BMI \> IOTF 30, 12-16 years old)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Grenoble
Grenoble, 38000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bernard WUYAM, Dr
University Hospital, Grenoble
- PRINCIPAL INVESTIGATOR
Claudine Perrin, MD
CHU Grenoble, Pediatrics Department
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2011
First Posted
August 8, 2011
Study Start
September 1, 2007
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
June 28, 2012
Record last verified: 2012-06