Physical Condition and Bariatric Surgery (CaPaCITy)

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.

Study Overview

• Status: Recruiting
• Conditions: Obese Patients With Bariatric Surgery
• Intervention / Treatment: Behavioral: Physical activity program : without protein supplementation; Behavioral: Physical activity program : with protein supplementation; Behavioral: Physical activity program : aquabike; Behavioral: Physical activity program : bicycle

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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
Experimental: 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	Behavioral: 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
Experimental: 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	Behavioral: 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; Behavioral: 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.
Experimental: - 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	Behavioral: 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; Behavioral: 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.
Experimental: 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	Behavioral: 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; Behavioral: 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.
Experimental: - 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	Behavioral: 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; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Distance traveled at the 6-minute walking test (TM6)	at 4 months post-surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2017
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Bariatric surgery; Muscle; Protein supplementation; Morbid obesity; 6-minute walking test; Physical activity program; Physical condition
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: CHU-320; 2016-A01432-49 (Other Identifier: 2016-A01432-49)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No