Physical Condition and Bariatric Surgery

NCT ID: NCT03197857

Last Updated: 2018-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-23

Study Completion Date

2023-10-31

Brief Summary

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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

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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

Conditions

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Obese Patients With Bariatric Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

open

Study Groups

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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

Group Type EXPERIMENTAL

Physical activity program : without protein supplementation

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Physical activity program : with protein supplementation

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Physical activity program : aquabike

Intervention Type BEHAVIORAL

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.

Physical activity program : without protein supplementation

Intervention Type BEHAVIORAL

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

- 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

Group Type EXPERIMENTAL

Physical activity program : aquabike

Intervention Type BEHAVIORAL

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.

Physical activity program : with protein supplementation

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Physical activity program : bicycle

Intervention Type BEHAVIORAL

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.

Physical activity program : without protein supplementation

Intervention Type BEHAVIORAL

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

- 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

Group Type EXPERIMENTAL

Physical activity program : bicycle

Intervention Type BEHAVIORAL

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.

Physical activity program : with protein supplementation

Intervention Type BEHAVIORAL

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

Interventions

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Physical 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.

Intervention Type BEHAVIORAL

Physical 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.

Intervention Type BEHAVIORAL

Physical 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

Intervention Type BEHAVIORAL

Physical 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yves BOIRIE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

04 73 75 11 95

Facility Contacts

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Patrick LACARIN

Role: primary

04 73 75 11 95

Other Identifiers

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2016-A01432-49

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-320

Identifier Type: -

Identifier Source: org_study_id

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