Determination of Factors Influencing the Physical Condition of Obese Patients Following Bariatric Surgery. Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Distance traveled at the 6-minute walking test (TM6)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
open
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Physical activity program : without protein supplementation (Behavioral)
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
Intervention: Physical activity program : with protein supplementation (Behavioral)
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
Intervention: Physical activity program : aquabike (Behavioral)
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
Intervention: Physical activity program : without protein supplementation (Behavioral)
- 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
Intervention: Physical activity program : aquabike (Behavioral)
- 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
Intervention: Physical activity program : with protein supplementation (Behavioral)
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
Intervention: Physical activity program : bicycle (Behavioral)
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
Intervention: Physical activity program : without protein supplementation (Behavioral)
- 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
Intervention: Physical activity program : bicycle (Behavioral)
- 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
Intervention: Physical activity program : with protein supplementation (Behavioral)
Outcomes
Primary Outcomes
Distance traveled at the 6-minute walking test (TM6)
Time Frame: at 4 months post-surgery
Secondary Outcomes
- 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 oxidative capacity(at 4 months post-surgery)
- muscle maximal strength evaluated by an isokinetic dynamometer(at 4 months post-surgery)