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- Klinische proef NCT01411605
Influence of Cardio-ventilatory Factors on Exercise Intolerance in Obese Adolescents: Effects of Exercise Training (VENTILOBE)
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.
Studie Overzicht
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Grenoble, Frankrijk, 38000
- Chu Grenoble
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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. |
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Exercise tolerance (Expiratory flow limitation and Operational Lung Volumes at rest and exercise, cardiorespiratory and subjective responses to incremental exercise)
Tijdsspanne: Participants will be followed for the duration of exercise training, an expected average of 12 weeks
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Participants will be followed for the duration of exercise training, an expected average of 12 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Polysomnography
Tijdsspanne: Participants will be followed for the duration of exercise training, an expected average of 12 weeks
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Explore the potential existence of obstructive sleep apnea and its effects on cardiovascular adaptations during exercise.
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Participants will be followed for the duration of exercise training, an expected average of 12 weeks
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Cardiorespiratory fitness (VO2max)
Tijdsspanne: Participants will be followed for the duration of exercise training, an expected average of 12 weeks
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Participants will be followed for the duration of exercise training, an expected average of 12 weeks
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Bernard WUYAM, Dr, University Hospital, Grenoble
- Hoofdonderzoeker: Claudine Perrin, MD, CHU Grenoble, Pediatrics Department
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 0718
- 2007-A00714-49 (Register-ID: ID RCB)
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