Physical Condition and Bariatric Surgery
- Conditions
- Obese Patients With Bariatric Surgery
- Registration Number
- NCT03197857
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- Brief Summary
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.
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- Male or Female
- Age between 18 and 60 years
- Body mass index: BMI> 40 kg / m2
- Candidates for bariatric surgery
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Distance traveled at the 6-minute walking test (TM6) at 4 months post-surgery
- Secondary Outcome Measures
Name Time Method muscle oxidative capacity at 4 months post-surgery food consumption at 4 months post-surgery physical activity level at 4 months post-surgery muscle fat infiltration at 4 months post-surgery Body composition 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 resting metabolic rate at 4 months post-surgery VO2 max at 4 months post-surgery muscle maximal strength evaluated by an isokinetic dynamometer at 4 months post-surgery
Trial Locations
- Locations (1)
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France