- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Grenoble, France, 38000
- CHU Grenoble
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Exercise tolerance (Expiratory flow limitation and Operational Lung Volumes at rest and exercise, cardiorespiratory and subjective responses to incremental exercise)
Délai: Participants will be followed for the duration of exercise training, an expected average of 12 weeks
|
Participants will be followed for the duration of exercise training, an expected average of 12 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Polysomnography
Délai: Participants will be followed for the duration of exercise training, an expected average of 12 weeks
|
Explore the potential existence of obstructive sleep apnea and its effects on cardiovascular adaptations during exercise.
|
Participants will be followed for the duration of exercise training, an expected average of 12 weeks
|
Cardiorespiratory fitness (VO2max)
Délai: Participants will be followed for the duration of exercise training, an expected average of 12 weeks
|
Participants will be followed for the duration of exercise training, an expected average of 12 weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Bernard WUYAM, Dr, University Hospital, Grenoble
- Chercheur principal: Claudine Perrin, MD, CHU Grenoble, Pediatrics Department
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 0718
- 2007-A00714-49 (Identificateur de registre: ID RCB)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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