Clinical trial NCT03197857: Physical Condition and Bariatric Surgery
Official title: Determination of Factors Influencing the Physical Condition of Obese Patients Following Bariatric Surgery. Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obese Patients With Bariatric Surgery
Keywords: Bariatric surgery
Morbid obesity
Physical condition
Muscle
6-minute walking test
Protein supplementation
Physical activity program
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Distance traveled at the 6-minute walking test (TM6)
timeFrame: at 4 months post-surgery
Secondary outcomes:
measure: Body composition
timeFrame: at 4 months post-surgery
measure: resting metabolic rate
timeFrame: at 4 months post-surgery
measure: VO2 max
timeFrame: at 4 months post-surgery
measure: food consumption
timeFrame: at 4 months post-surgery
measure: physical activity level
timeFrame: at 4 months post-surgery
measure: muscle maximal strength evaluated by an isokinetic dynamometer
timeFrame: at 4 months post-surgery
measure: evaluation of the equilibrium of the body on a stabilometric platform
timeFrame: at 4 months post-surgery
measure: muscle typology
timeFrame: at 4 months post-surgery
measure: muscle oxidative capacity
timeFrame: at 4 months post-surgery
measure: muscle fat infiltration
timeFrame: at 4 months post-surgery
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Yves BOIRIE
role: PRINCIPAL_INVESTIGATOR
References: