Physical Condition and Bariatric Surgery (CaPaCITy)
30 april 2018 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Gedetailleerde beschrijving
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
Studietype
Ingrijpend
Inschrijving (Verwacht)
150
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Clermont-Ferrand, Frankrijk, 63003
- Werving
- CHU Clermont-Ferrand
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 60 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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.
|
|
Experimenteel: - 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.
|
|
Experimenteel: 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.
|
|
Experimenteel: - 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Distance traveled at the 6-minute walking test (TM6)
Tijdsspanne: at 4 months post-surgery
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at 4 months post-surgery
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Body composition
Tijdsspanne: at 4 months post-surgery
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at 4 months post-surgery
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resting metabolic rate
Tijdsspanne: at 4 months post-surgery
|
at 4 months post-surgery
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VO2 max
Tijdsspanne: at 4 months post-surgery
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at 4 months post-surgery
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food consumption
Tijdsspanne: at 4 months post-surgery
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at 4 months post-surgery
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physical activity level
Tijdsspanne: at 4 months post-surgery
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at 4 months post-surgery
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muscle maximal strength evaluated by an isokinetic dynamometer
Tijdsspanne: at 4 months post-surgery
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at 4 months post-surgery
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evaluation of the equilibrium of the body on a stabilometric platform
Tijdsspanne: at 4 months post-surgery
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at 4 months post-surgery
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muscle typology
Tijdsspanne: at 4 months post-surgery
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at 4 months post-surgery
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muscle oxidative capacity
Tijdsspanne: at 4 months post-surgery
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at 4 months post-surgery
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muscle fat infiltration
Tijdsspanne: at 4 months post-surgery
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at 4 months post-surgery
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
23 oktober 2017
Primaire voltooiing (Verwacht)
1 mei 2023
Studie voltooiing (Verwacht)
1 oktober 2023
Studieregistratiedata
Eerst ingediend
4 mei 2017
Eerst ingediend dat voldeed aan de QC-criteria
21 juni 2017
Eerst geplaatst (Werkelijk)
23 juni 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
1 mei 2018
Laatste update ingediend die voldeed aan QC-criteria
30 april 2018
Laatst geverifieerd
1 april 2018
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CHU-320
- 2016-A01432-49 (Andere identificatie: 2016-A01432-49)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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