Physical Condition and Bariatric Surgery (CaPaCITy)

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Obese Patients With Bariatric Surgery

Treatments: Behavioral: Physical activity program : aquabike; Behavioral: Physical activity program : with protein supplementation; Behavioral: Physical activity program : bicycle; Behavioral: Physical activity program : without protein supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT03197857

CHU-320

2016-A01432-49 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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150 participants in 6 patient groups

Control

Experimental group

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

Treatment:

Behavioral: Physical activity program : without protein supplementation

Control + protein supplementation

Experimental group

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

Treatment:

Behavioral: Physical activity program : with protein supplementation

Training in aquabike

Experimental group

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

Treatment:

Behavioral: Physical activity program : aquabike

Behavioral: Physical activity program : without protein supplementation

- Training in aquabike + protein supplementation

Experimental group

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

Treatment:

Behavioral: Physical activity program : aquabike

Behavioral: Physical activity program : with protein supplementation

Bicycle training

Experimental group

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

Treatment:

Behavioral: Physical activity program : bicycle

Behavioral: Physical activity program : without protein supplementation

- Bicycle training + protein supplementation

Experimental group

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

Treatment:

Behavioral: Physical activity program : bicycle

Behavioral: Physical activity program : with protein supplementation