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Physical Condition and Bariatric Surgery (CaPaCITy)

30 april 2018 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Interventionell

Inskrivning (Förväntat)

150

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Frankrike
      • Clermont-Ferrand, Frankrike, 63003
        • Rekrytering
        • CHU Clermont-Ferrand

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 60 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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:

  • Control
  • Control + protein supplementation
  • Training in aquabike
  • Training in aquabike + protein supplementation
  • Bicycle training
  • Bicycle training + protein supplementation
Beteende: Physical activity program : 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
Experimentell: 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:

  • Control
  • Control + protein supplementation
  • Training in aquabike
  • Training in aquabike + protein supplementation
  • Bicycle training
  • Bicycle training + protein supplementation
Beteende: Physical activity program : with 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
Experimentell: 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:

  • Control
  • Control + protein supplementation
  • Training in aquabike
  • Training in aquabike + protein supplementation
  • Bicycle training
  • Bicycle training + protein supplementation
Beteende: Physical activity program : 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
Beteende: Physical activity program : aquabike
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.
Experimentell: - 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:

  • Control
  • Control + protein supplementation
  • Training in aquabike
  • Training in aquabike + protein supplementation
  • Bicycle training
  • Bicycle training + protein supplementation
Beteende: Physical activity program : with 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
Beteende: Physical activity program : aquabike
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.
Experimentell: 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:

  • Control
  • Control + protein supplementation
  • Training in aquabike
  • Training in aquabike + protein supplementation
  • Bicycle training
  • Bicycle training + protein supplementation
Beteende: Physical activity program : 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
Beteende: Physical activity program : bicycle
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.
Experimentell: - 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:

  • Control
  • Control + protein supplementation
  • Training in aquabike
  • Training in aquabike + protein supplementation
  • Bicycle training
  • Bicycle training + protein supplementation
Beteende: Physical activity program : with 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
Beteende: Physical activity program : bicycle
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Distance traveled at the 6-minute walking test (TM6)
Tidsram: at 4 months post-surgery
at 4 months post-surgery

Sekundära resultatmått

Resultatmått
Tidsram
Body composition
Tidsram: at 4 months post-surgery
at 4 months post-surgery
resting metabolic rate
Tidsram: at 4 months post-surgery
at 4 months post-surgery
VO2 max
Tidsram: at 4 months post-surgery
at 4 months post-surgery
food consumption
Tidsram: at 4 months post-surgery
at 4 months post-surgery
physical activity level
Tidsram: at 4 months post-surgery
at 4 months post-surgery
muscle maximal strength evaluated by an isokinetic dynamometer
Tidsram: at 4 months post-surgery
at 4 months post-surgery
evaluation of the equilibrium of the body on a stabilometric platform
Tidsram: at 4 months post-surgery
at 4 months post-surgery
muscle typology
Tidsram: at 4 months post-surgery
at 4 months post-surgery
muscle oxidative capacity
Tidsram: at 4 months post-surgery
at 4 months post-surgery
muscle fat infiltration
Tidsram: at 4 months post-surgery
at 4 months post-surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospital, Clermont-Ferrand

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

23 oktober 2017

Primärt slutförande (Förväntat)

1 maj 2023

Avslutad studie (Förväntat)

1 oktober 2023

Studieregistreringsdatum

Först inskickad

4 maj 2017

Först inskickad som uppfyllde QC-kriterierna

21 juni 2017

Första postat (Faktisk)

23 juni 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 maj 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 april 2018

Senast verifierad

1 april 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CHU-320
  • 2016-A01432-49 (Annan identifierare: 2016-A01432-49)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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