- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03197857
Physical Condition and Bariatric Surgery (CaPaCITy)
Determination of Factors Influencing the Physical Condition of Obese Patients Following Bariatric Surgery. Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Physical condition will be evaluated in obese patients before surgery and 1, 4, 6, 12, 18 and 24 months after surgery.
Between 1 and 4 months after surgery, participants will be assigned to one of the postoperative care groups:
- Control
- Control + protein supplementation
- Training in aquabike
- Training in aquabike + protein supplementation
- Bicycle training
- Bicycle training + protein supplementation
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Clermont-Ferrand, France, 63003
- Recrutement
- CHU Clermont-Ferrand
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Male or Female
- Age between 18 and 60 years
- Body mass index: BMI> 40 kg / m2
- Candidates for bariatric surgery
Exclusion Criteria:
- Subject under 18 or over 60 years of age
- Biological assessment considered abnormal by the investigator
- HIV serology or known positive HCV
- Pregnant or nursing women
- For women of childbearing age: beta-hCG positive dosage or absence of contraception deemed reliable (oral contraceptive, IUD, implant or hormonal patch)
- Medical or surgical history (judged by the investigator to be inconsistent with the study)
- Subject with cardiorespiratory and / or osteo-articular disorders limiting their ability to perform physical tests or training
- Subject with cardiovascular or neoplastic disease
- Subjects with an infection in the 3 months prior to inclusion
- Hypercorticism and uncontrolled dysthyroidism
- Patient with known neuro-muscular pathology: myopathy, myasthenia gravis, rhabdomyolysis, paraplegia, hemiplegia
- Patient with chronic or acute inflammatory disease the 3 months before inclusion
- CRP> 20 mg / l
- Person treated with or having stopped treatment for less than 3 months prior to inclusion by corticosteroids, immunosuppressant, anabolic agent, growth hormone
- Person with an unstable psychiatric condition
- Blood donation in the two months preceding the study
- High alcohol consumption (> 2 to 3 drinks per day depending on sex) or presence of drug addiction
- Significant smoking (> 5 cigarettes / day or equivalent in cigars or pipe tobacco)
- Intense sports activity (> 5 hours / week)
- Subjects excluded from another study or having received more than 4500 € in the year following their participation in clinical studies
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Control
Physical condition will be evaluated in obese patients before surgery and 1, 4, 6, 12, 18 and 24 months after surgery. Between 1 and 4 months after surgery, participants will be assigned to one of the postoperative care groups:
|
The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation
|
Expérimental: Control + protein supplementation
Physical condition will be evaluated in obese patients before surgery and 1, 4, 6, 12, 18 and 24 months after surgery. Between 1 and 4 months after surgery, participants will be assigned to one of the postoperative care groups:
|
The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation
|
Expérimental: Training in aquabike
Physical condition will be evaluated in obese patients before surgery and 1, 4, 6, 12, 18 and 24 months after surgery. Between 1 and 4 months after surgery, participants will be assigned to one of the postoperative care groups:
|
The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation
The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation.
|
Expérimental: - Training in aquabike + protein supplementation
Physical condition will be evaluated in obese patients before surgery and 1, 4, 6, 12, 18 and 24 months after surgery. Between 1 and 4 months after surgery, participants will be assigned to one of the postoperative care groups:
|
The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation
The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation.
|
Expérimental: Bicycle training
Physical condition will be evaluated in obese patients before surgery and 1, 4, 6, 12, 18 and 24 months after surgery. Between 1 and 4 months after surgery, participants will be assigned to one of the postoperative care groups:
|
The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation
The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation.
|
Expérimental: - Bicycle training + protein supplementation
Physical condition will be evaluated in obese patients before surgery and 1, 4, 6, 12, 18 and 24 months after surgery. Between 1 and 4 months after surgery, participants will be assigned to one of the postoperative care groups:
|
The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation
The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Distance traveled at the 6-minute walking test (TM6)
Délai: at 4 months post-surgery
|
at 4 months post-surgery
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Body composition
Délai: at 4 months post-surgery
|
at 4 months post-surgery
|
resting metabolic rate
Délai: at 4 months post-surgery
|
at 4 months post-surgery
|
VO2 max
Délai: at 4 months post-surgery
|
at 4 months post-surgery
|
food consumption
Délai: at 4 months post-surgery
|
at 4 months post-surgery
|
physical activity level
Délai: at 4 months post-surgery
|
at 4 months post-surgery
|
muscle maximal strength evaluated by an isokinetic dynamometer
Délai: at 4 months post-surgery
|
at 4 months post-surgery
|
evaluation of the equilibrium of the body on a stabilometric platform
Délai: at 4 months post-surgery
|
at 4 months post-surgery
|
muscle typology
Délai: at 4 months post-surgery
|
at 4 months post-surgery
|
muscle oxidative capacity
Délai: at 4 months post-surgery
|
at 4 months post-surgery
|
muscle fat infiltration
Délai: at 4 months post-surgery
|
at 4 months post-surgery
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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 (Réel)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CHU-320
- 2016-A01432-49 (Autre identifiant: 2016-A01432-49)
Informations sur les médicaments et les dispositifs, documents d'étude
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Étudie un produit d'appareil réglementé par la FDA américaine
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