Physical Condition and Bariatric Surgery (CaPaCITy)
30 aprile 2018 aggiornato da: University Hospital, Clermont-Ferrand
Determination of Factors Influencing the Physical Condition of Obese Patients Following Bariatric Surgery. Randomized Controlled Trial
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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Descrizione dettagliata
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
Tipo di studio
Interventistico
Iscrizione (Anticipato)
150
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Clermont-Ferrand, Francia, 63003
- Reclutamento
- CHU Clermont-Ferrand
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 60 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
|
Sperimentale: 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.
|
|
Sperimentale: - 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: - 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Distance traveled at the 6-minute walking test (TM6)
Lasso di tempo: at 4 months post-surgery
|
at 4 months post-surgery
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Body composition
Lasso di tempo: at 4 months post-surgery
|
at 4 months post-surgery
|
|
resting metabolic rate
Lasso di tempo: at 4 months post-surgery
|
at 4 months post-surgery
|
|
VO2 max
Lasso di tempo: at 4 months post-surgery
|
at 4 months post-surgery
|
|
food consumption
Lasso di tempo: at 4 months post-surgery
|
at 4 months post-surgery
|
|
physical activity level
Lasso di tempo: at 4 months post-surgery
|
at 4 months post-surgery
|
|
muscle maximal strength evaluated by an isokinetic dynamometer
Lasso di tempo: at 4 months post-surgery
|
at 4 months post-surgery
|
|
evaluation of the equilibrium of the body on a stabilometric platform
Lasso di tempo: at 4 months post-surgery
|
at 4 months post-surgery
|
|
muscle typology
Lasso di tempo: at 4 months post-surgery
|
at 4 months post-surgery
|
|
muscle oxidative capacity
Lasso di tempo: at 4 months post-surgery
|
at 4 months post-surgery
|
|
muscle fat infiltration
Lasso di tempo: at 4 months post-surgery
|
at 4 months post-surgery
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
23 ottobre 2017
Completamento primario (Anticipato)
1 maggio 2023
Completamento dello studio (Anticipato)
1 ottobre 2023
Date di iscrizione allo studio
Primo inviato
4 maggio 2017
Primo inviato che soddisfa i criteri di controllo qualità
21 giugno 2017
Primo Inserito (Effettivo)
23 giugno 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
1 maggio 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
30 aprile 2018
Ultimo verificato
1 aprile 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CHU-320
- 2016-A01432-49 (Altro identificatore: 2016-A01432-49)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .