- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02175810
Impact of Bariatric Surgery on Cardiorespiratory Function
Impact of Bariatric Surgery on Cardiorespiratory Function: an Observational Study
Obesity is a growing problem worldwide and its prevention has become one of the leading priorities for the World Health Organisation. Obesity results from chronic imbalance between energy intake and energy expenditure. Although early prevention of obesity is preferable, surgical treatment is often required for severely obese people.
Bariatric surgery has been shown to be the most effective therapy for severe obesity. Weight loss following bariatric surgery results in significant improvements in coexisting comorbidities, such as diabetes and hypertension but there is controversy whether bariatric surgery also improves aerobic capacity.
The purpose of this study is to investigate the effects of bariatric surgery on cardiopulmonary function and on daily physical activity. It is hypothesized that bariatric surgery will improve aerobic capacity and result in beneficial lifestyle changes from sedentary to more active.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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London, Royaume-Uni, SW17 0RE
- Recrutement
- St George's Healthcare NHS Trust
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Contact:
- Dimitra Nikoletou
- Numéro de téléphone: +44 20 8725 5647
- E-mail: dinikole@sgul.ac.uk
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Sous-enquêteur:
- Emma R McGlone
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Sous-enquêteur:
- Ommar A Khan
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Ages 18 years to 50 years
- Patients enrolled in the bariatric surgery program of St George's Hospital with BMI > 40 kg/m2, or 35-40 kg/m2 in the presence of other obesity-related comorbidities such as hypertension or type- 2 diabetes
Exclusion Criteria:
- Locomotor difficulties which would prevent participants from completing the cardiopulmonary exercise testing
- Weight > 190 kg (due to weight restrictions of equipment used to transfer patients in the event of medical emergencies)
- Cognitive impairment
- Patients unable to follow instructions in English
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Cardiorespiratory function assessed by peak oxygen consumption (VO2peak)
Délai: One to two weeks before surgery and six months after surgery
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One to two weeks before surgery and six months after surgery
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Lung function
Délai: One to two weeks before surgery and six months after surgery
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Lung function will be assessed by spirometry and body plethysmography
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One to two weeks before surgery and six months after surgery
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Heart function
Délai: One to two weeks before surgery and six months after surgery
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Echocardiography will be performed to assess heart function.
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One to two weeks before surgery and six months after surgery
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Inspiratory muscle strength
Délai: One to two weeks before surgery and six months after surgery
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Maximal inspiratory pressure and sniff nasal pressure will be recorded.
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One to two weeks before surgery and six months after surgery
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Peripheral muscle strength
Délai: One to two weeks before surgery and six months after surgery
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Maximum isometric strength of hand/ forearm, quadriceps and hip flexors muscles will be evaluated
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One to two weeks before surgery and six months after surgery
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Free living sedentary and physical activity times
Délai: One to two weeks before surgery and six months after surgery
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Daily physical activity habits will be assessed by an accelerometer and International Physical Activity Questionnaire: Long (IPAQ-Long).
Participants will be required to wear the accelerometer for four consecutive days during the two study points.
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One to two weeks before surgery and six months after surgery
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Marcia S Volpe, Universidade Federal Triangulo Mineiro
- Chaise d'étude: Dimitra Nikoletou, Kingston University and St George's University of London
- Directeur d'études: Marcus Reddy, St George's Healthcare NHS Trust
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
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 (Réel)
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
- 13.0217
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