NCT03197857

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

October 23, 2017

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

5.5 years

First QC Date

May 4, 2017

Last Update Submit

April 30, 2018

Conditions

Obese Patients With Bariatric Surgery

Keywords

Bariatric surgeryMorbid obesityPhysical conditionMuscle6-minute walking testProtein supplementationPhysical activity program

Outcome Measures

Primary Outcomes (1)

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

    at 4 months post-surgery

Secondary Outcomes (10)

  • Body composition

    at 4 months post-surgery

  • resting metabolic rate

    at 4 months post-surgery

  • VO2 max

    at 4 months post-surgery

  • food consumption

    at 4 months post-surgery

  • physical activity level

    at 4 months post-surgery

  • +5 more secondary outcomes

Study Arms (6)

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

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

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

Behavioral: Physical activity program : aquabikeBehavioral: 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

Behavioral: Physical activity program : aquabikeBehavioral: 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

Behavioral: Physical activity program : bicycleBehavioral: 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

Behavioral: Physical activity program : bicycleBehavioral: Physical activity program : with protein supplementation

Interventions

Physical activity program : aquabikeBEHAVIORAL

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 supplementationTraining in aquabike
Physical activity program : bicycleBEHAVIORAL

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 supplementationBicycle training
Physical activity program : with protein supplementationBEHAVIORAL

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- Training in aquabike + protein supplementationControl + protein supplementation
Physical activity program : without protein supplementationBEHAVIORAL

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 trainingControlTraining in aquabike

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or Female
  • Age between 18 and 60 years
  • Body mass index: BMI\> 40 kg / m2
  • Candidates for bariatric surgery

You may not qualify if:

  • 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
  • Hypercorticism and uncontrolled dysthyroidism
  • Patient with known neuro-muscular pathology: myopathy, myasthenia gravis, rhabdomyolysis, paraplegia, hemiplegia
  • CRP\> 20 mg / l
  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yves BOIRIE

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
open
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2017

First Posted

June 23, 2017

Study Start

October 23, 2017

Primary Completion

May 1, 2023

Study Completion

October 1, 2023

Last Updated

May 1, 2018

Record last verified: 2018-04

Locations

FR(1)