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Status unknownNCT03197857CaPaCITyUpdated May 1, 2018

Physical Condition and Bariatric Surgery

An interventional study of Physical activity program : aquabike and Physical activity program : bicycle in Obese Patients With Bariatric Surgery, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-05-01.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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
02

Conditions studied

  • Obese Patients With Bariatric Surgery

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Keywords

  • Bariatric surgery
  • Morbid obesity
  • Physical condition
  • Muscle
  • 6-minute walking test
  • Protein supplementation
  • Physical activity program
03

In context

Disease

1,327 studies on the registry are indexed under Disease; 596 are open to participants now.

This study's planned enrollment of 150 is above the median of 80 across 732 interventional studies indexed under Disease.

Browse Disease studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    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

    Behavioral: Physical activity program : without protein supplementation

  • Experimental
    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

    Behavioral: Physical activity program : with protein supplementation

  • Experimental
    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

    Behavioral: Physical activity program : aquabike · Behavioral: Physical activity program : without protein supplementation

  • Experimental
    - 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

    Behavioral: Physical activity program : aquabike · Behavioral: Physical activity program : with protein supplementation

  • Experimental
    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

    Behavioral: Physical activity program : bicycle · Behavioral: Physical activity program : without protein supplementation

  • Experimental
    - 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

    Behavioral: Physical activity program : bicycle · Behavioral: Physical activity program : with 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

06

What researchers measure

Primary outcomes

  1. Distance traveled at the 6-minute walking test (TM6)

    Time frame: at 4 months post-surgery

Secondary outcomes

  1. Body composition

    Time frame: at 4 months post-surgery

  2. resting metabolic rate

    Time frame: at 4 months post-surgery

  3. VO2 max

    Time frame: at 4 months post-surgery

  4. food consumption

    Time frame: at 4 months post-surgery

  5. physical activity level

    Time frame: at 4 months post-surgery

  6. muscle maximal strength evaluated by an isokinetic dynamometer

    Time frame: at 4 months post-surgery

  7. evaluation of the equilibrium of the body on a stabilometric platform

    Time frame: at 4 months post-surgery

  8. muscle typology

    Time frame: at 4 months post-surgery

  9. muscle oxidative capacity

    Time frame: at 4 months post-surgery

  10. muscle fat infiltration

    Time frame: at 4 months post-surgery

07

Study locations

1 of 1 sites recruiting
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03197857
Lead sponsor
University Hospital, Clermont-Ferrand
Responsible party
Sponsor
First posted
Jun 23, 2017
Start date
Oct 23, 2017
Primary completion
May 2023 (estimated)
Completion
Oct 2023 (estimated)
Last update
May 1, 2018

Study contacts

Patrick LACARIN
Contact
placarin@chu-clermontferrand.fr
04 73 75 11 95
Yves BOIRIE
principal investigator · University Hospital, Clermont-Ferrand

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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