Clinical trial NCT02333903: Adapted Physical Activity Program After Sleeve Gastrectomy
Official title: Effects of an Adapted Physical Activity Program on Health and Physical Condition After Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Keywords: Obesity
Sleeve gastrectomy
Personalized physical activity program
Body Composition
Fat mass
Lean mass
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: Université de Lille
First posted: 2015-01-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the ratio of lean mass losses over total body mass losses between patients undergoing sleeve gastrectomy followed by physical activity training versus patients undergoing sleeve gastrectomy only

Detailed description: This study will assess prospectively and objectively the potential benefits of a personalized and specific rehabilitation program designed for patients who undergone sleeve gastrectomy. This strategy will help to reduce fat mass and to limit lean mass loss, in order to prevent in the short term the overweight recurrence. Also,the improvement of physical and metabolic status is expected.

Eligibility criteria: Inclusion Criteria:

* BMI \>40 kg/m² or BMI\>35kg/m² with comorbidities qualifying for bariatric surgery
* Stable obesity or obesity evolving for more than 5 years
* Patient cleared by the surgeon for sleeve gastrectomy one month before recruitment
* Absence of contraindication for a sub-maximal stress test
* Performance of a polysomnography before surgery
* Signed informed consent
* Patient benefiting from Health Care Coverage

Exclusion Criteria:

* Absence of preliminary and regular medical check-ups mandatory before sleeve gastrectomy
* Anticipated difficulty for patient follow-up
* Mental diseases (psychosis, depression, suicidal behavior or history)
* Eating disorders
* Lack of informed consent or cooperation
* Unsufficient patient commitment
* Patient under judiciary protection
* Patient not able to comply with any or all the research procedures over time including physical activity
* Patient excluded from the french database of volunteers for clinical trials

Primary outcomes:
measure: Change in the ratio of lean mass losses over total body mass losses
timeFrame: 1 month, 6 months, 12 months after surgery
Secondary outcomes:
measure: Changes in systolic blood pressure
timeFrame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
measure: Change in the Body Mass Index (BMI)
timeFrame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
measure: Changes in the lipid profile
timeFrame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
measure: Changes of glycemia values
timeFrame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
measure: Changes of HbA1C values
timeFrame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
measure: Changes of albuminemia values
timeFrame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
measure: Changes of insulinemia values
timeFrame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
measure: Changes of creatinemia values
timeFrame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
measure: Change in the body composition analysis with segmental analysis
timeFrame: 1 month, 6 months, 12 months after surgery
measure: Change in the qualitative evaluation of physical activity.
timeFrame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
measure: Change in the quantitative evaluation of physical activity.
timeFrame: 1 month, 6 months and 12 months after surgery
measure: Sub-maximal stress testing
timeFrame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
measure: Change in the quantitative evaluation of the sleep quality
timeFrame: Before and 12 months after surgery
measure: Change in the qualitative evaluation of the sleep quality
timeFrame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
measure: Change in the energy balance
timeFrame: 1 month, 6 months, 12 months after surgery
measure: Change in the 6 min Walking test
timeFrame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
measure: Change in the quantitative self esteem evaluation
timeFrame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
measure: Change in the quantitative evaluation of the health related quality of life
timeFrame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Other outcomes:
Locations:
city: Lomme
country: France
facility: Hopital Saint Philibert
Study officials:
affiliation: Groupement des Hôpitaux de l'Institut Catholique de Lille
name: Antoine Cracco, MD
role: PRINCIPAL_INVESTIGATOR
References: