Obese Patients With Bariatric SurgeryCaPaCITyNCT03197857
Physical Condition and Bariatric Surgery
A study testing Physical activity program : aquabike, Physical activity program : bicycle and Physical activity program : with protein supplementation in people with Obese Patients With Bariatric Surgery, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obese Patients With Bariatric Surgery
- What is being tested?
- Physical activity program : aquabike, Physical activity program : bicycle and Physical activity program : with protein supplementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 23 Oct 2017to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or Female
- Age between 18 and 60 years
- Body mass index: BMI> 40 kg / m2
- Candidates for bariatric surgery
Who cannot join
- 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)
Show all 20Show fewer
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Yves BOIRIE
About this study
Official title: Determination of Factors Influencing the Physical Condition of Obese Patients Following Bariatric Surgery. Randomized Controlled Trial
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.
Read the 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
- Conditions
- Obese Patients With Bariatric Surgery
- Being tested
- Physical activity program : aquabike, Physical activity program : bicycle, Physical activity program : with protein supplementation, Physical activity program : without protein supplementation
- Keywords
- Bariatric surgery, Morbid obesity, Physical condition, Muscle, 6-minute walking test, Protein supplementation, Physical activity program
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity program : aquabikeBehavioural
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 : bicycleBehavioural
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 supplementationBehavioural
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 supplementationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | 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 Receives: Behavioral: Physical activity program : without protein supplementation |
| Control + protein supplementation | Experimental | 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 Receives: Behavioral: Physical activity program : with protein supplementation |
| Training in aquabike | Experimental | 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 Receives: Behavioral: Physical activity program : aquabike; Behavioral: Physical activity program : without protein supplementation |
| - Training in aquabike + protein supplementation | Experimental | 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 Receives: Behavioral: Physical activity program : aquabike; Behavioral: Physical activity program : with protein supplementation |
| Bicycle training | Experimental | 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 Receives: Behavioral: Physical activity program : bicycle; Behavioral: Physical activity program : without protein supplementation |
| - Bicycle training + protein supplementation | Experimental | 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 Receives: Behavioral: Physical activity program : bicycle; Behavioral: Physical activity program : with protein supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance traveled at the 6-minute walking test (TM6)
Measured: at 4 months post-surgery
Secondary outcomes (10)
Body composition
Measured: at 4 months post-surgery
resting metabolic rate
Measured: at 4 months post-surgery
VO2 max
Measured: at 4 months post-surgery
food consumption
Measured: at 4 months post-surgery
physical activity level
Measured: at 4 months post-surgery
muscle maximal strength evaluated by an isokinetic dynamometer
Measured: at 4 months post-surgery
evaluation of the equilibrium of the body on a stabilometric platform
Measured: at 4 months post-surgery
muscle typology
Measured: at 4 months post-surgery
muscle oxidative capacity
Measured: at 4 months post-surgery
muscle fat infiltration
Measured: at 4 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start23 Oct 2017
- Primary completionMay 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese Patients With Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves BOIRIE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197857
- Sponsor's protocol ID
- CHU-320
- Other IDs
- 2016-A01432-49
- Acronym
- CaPaCITy
- Status last verified
- Apr 2018
- First submitted
- 4 May 2017
- Last updated
- 1 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Factors Influencing the Physical Condition of Obese Patients Following Bariatric Surgery. Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03197857
- Acronym / sponsor ID
- CaPaCITy / CHU-320
- Conditions
- Obese Patients With Bariatric Surgery
- Keywords
- Bariatric surgery, Morbid obesity, Physical condition, Muscle, 6-minute walking test, Protein supplementation, Physical activity program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 23 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: Physical activity program : without protein supplementationPhysical 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 |
| Control + protein supplementation | Experimental | Behavioral: Physical activity program : with protein supplementationPhysical 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 |
| Training in aquabike | Experimental | Behavioral: Physical activity program : aquabike, Behavioral: Physical activity program : without protein supplementationPhysical 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 |
| - Training in aquabike + protein supplementation | Experimental | Behavioral: Physical activity program : aquabike, Behavioral: Physical activity program : with protein supplementationPhysical 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 |
| Bicycle training | Experimental | Behavioral: Physical activity program : bicycle, Behavioral: Physical activity program : without protein supplementationPhysical 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 |
| - Bicycle training + protein supplementation | Experimental | Behavioral: Physical activity program : bicycle, Behavioral: Physical activity program : with protein supplementationPhysical 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or Female
- Age between 18 and 60 years
- Body mass index: BMI> 40 kg / m2
- Candidates for bariatric surgery
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity program : aquabikeThe 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. | Behavioural | - Training in aquabike + protein supplementation, Training in aquabike |
| Physical activity program : bicycleThe 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. | Behavioural | - Bicycle training + protein supplementation, Bicycle training |
| Physical activity program : with protein supplementationThe 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 | Behavioural | - Bicycle training + protein supplementation, - Training in aquabike + protein supplementation, Control + protein supplementation |
| Physical activity program : without protein supplementationThe 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 | Behavioural | Bicycle training, Control, Training in aquabike |
Primary outcome
Distance traveled at the 6-minute walking test (TM6)
Time frame: at 4 months post-surgery
10 secondary outcomes
Body composition
Time frame: at 4 months post-surgery
resting metabolic rate
Time frame: at 4 months post-surgery
VO2 max
Time frame: at 4 months post-surgery
food consumption
Time frame: at 4 months post-surgery
physical activity level
Time frame: at 4 months post-surgery
muscle maximal strength evaluated by an isokinetic dynamometer
Time frame: at 4 months post-surgery
evaluation of the equilibrium of the body on a stabilometric platform
Time frame: at 4 months post-surgery
muscle typology
Time frame: at 4 months post-surgery
muscle oxidative capacity
Time frame: at 4 months post-surgery
muscle fat infiltration
Time frame: at 4 months post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves BOIRIE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity program : aquabike, Physical activity program : bicycle and Physical activity program : with protein supplementation in people with Obese Patients With Bariatric Surgery, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance traveled at the 6-minute walking test (TM6) (time frame: at 4 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.