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Physical Condition and Bariatric Surgery

Determination of Factors Influencing the Physical Condition of Obese Patients Following Bariatric Surgery. Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03197857
Acronym
CaPaCITy
Enrollment
150
Registered
2017-06-23
Start date
2017-10-23
Completion date
2023-10-31
Last updated
2018-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese Patients With Bariatric Surgery

Keywords

Bariatric surgery, Morbid obesity, Physical condition, Muscle, 6-minute walking test, Protein supplementation, Physical activity program

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

Interventions

BEHAVIORALPhysical 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.

BEHAVIORALPhysical 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.

BEHAVIORALPhysical 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

BEHAVIORALPhysical 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

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Masking description

open

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frame
Distance traveled at the 6-minute walking test (TM6)at 4 months post-surgery

Secondary

MeasureTime frame
resting metabolic rateat 4 months post-surgery
VO2 maxat 4 months post-surgery
food consumptionat 4 months post-surgery
physical activity levelat 4 months post-surgery
Body compositionat 4 months post-surgery
evaluation of the equilibrium of the body on a stabilometric platformat 4 months post-surgery
muscle typologyat 4 months post-surgery
muscle oxidative capacityat 4 months post-surgery
muscle fat infiltrationat 4 months post-surgery
muscle maximal strength evaluated by an isokinetic dynamometerat 4 months post-surgery

Countries

France

Contacts

Primary ContactPatrick LACARIN
placarin@chu-clermontferrand.fr04 73 75 11 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026