Obesity
Conditions
Keywords
Obesity, Sleeve gastrectomy, Personalized physical activity program, Body Composition, Fat mass, Lean mass
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.
Interventions
OTHERPersonalized Physical Activity
1.5 hours physical training sessions, twice a week for 1 year, under the supervision of a dedicated coach specialized in supporting overweighted patients. Typical training session organized for small groups (5 patients) will consist of aerobic exercises, muscular strengthening (4 peripheral members and abdominal muscular belt), followed by stretching exercises.
Sponsors
Université de Lille
Lille Catholic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the ratio of lean mass losses over total body mass losses | 1 month, 6 months, 12 months after surgery | Percentage of lean mass loss compared to total body weight loss measured with bioimpedancemetry and dual energy X-Rays absorptiometry (DXA) at 1, 6 and 12 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Body Mass Index (BMI) | 1 month, 3 months, 6 months, 9 months and 12 months after surgery | Anthropometric measures to estimate body Mass Index (BMI). |
| Changes in the lipid profile | 1 month, 3 months, 6 months, 9 months and 12 months after surgery | (total cholesterol, LDL HDL, Triglycerides) |
| Changes of glycemia values | 1 month, 3 months, 6 months, 9 months and 12 months after surgery | — |
| Changes of HbA1C values | 1 month, 3 months, 6 months, 9 months and 12 months after surgery | — |
| Changes of albuminemia values | 1 month, 3 months, 6 months, 9 months and 12 months after surgery | — |
| Changes of insulinemia values | 1 month, 3 months, 6 months, 9 months and 12 months after surgery | — |
| Changes of creatinemia values | 1 month, 3 months, 6 months, 9 months and 12 months after surgery | — |
| Change in the body composition analysis with segmental analysis | 1 month, 6 months, 12 months after surgery | Main parameter: Percentage of lean mass loss compared to total body weight loss measured with bioimpedancemetry at at 1, 6 and 12 months after surgery |
| Changes in systolic blood pressure | 1 month, 3 months, 6 months, 9 months and 12 months after surgery | — |
| Change in the quantitative evaluation of physical activity. | 1 month, 6 months and 12 months after surgery | Daily physical activity will be evaluated by accelerometer measurements. |
| Sub-maximal stress testing | 1 month, 3 months, 6 months, 9 months and 12 months after surgery | — |
| Change in the quantitative evaluation of the sleep quality | Before and 12 months after surgery | Comparison of sleep quality : micro awakeness index (average number per hour during Rapid Eye Movement (REM) and Non REM phases); index of micro awakeness following an apnea event. |
| Change in the qualitative evaluation of the sleep quality | 1 month, 3 months, 6 months, 9 months and 12 months after surgery | Comparison of the sleep quality by the mean of a visual analogic scale in a sleep diary |
| Change in the energy balance | 1 month, 6 months, 12 months after surgery | Energy balance analysis (energy intake vs energy expenditure) and detailed nutriments analysis. |
| Change in the 6 min Walking test | 1 month, 3 months, 6 months, 9 months and 12 months after surgery | Determination of the maximal walking distance performed by the patient after a 6 minutes walk |
| Change in the quantitative self esteem evaluation | 1 month, 3 months, 6 months, 9 months and 12 months after surgery | Rosenberg questionary for the evaluation of Self-esteem |
| Change in the quantitative evaluation of the health related quality of life | 1 month, 3 months, 6 months, 9 months and 12 months after surgery | Medical Outcome Study Short Form-36 (MOS SF-36) questionary |
| Change in the qualitative evaluation of physical activity. | 1 month, 3 months, 6 months, 9 months and 12 months after surgery | Daily physical activity will be evaluated by a self-questionary (IPAQ) |
Countries
France
Outcome results
None listed