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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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.
Hopital Saint Philibert
Lomme, France
Change in the ratio of lean mass losses over total body mass losses
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
Time frame: 1 month, 6 months, 12 months after surgery
Changes in systolic blood pressure
Time frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Change in the Body Mass Index (BMI)
Anthropometric measures to estimate body Mass Index (BMI).
Time frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes in the lipid profile
(total cholesterol, LDL HDL, Triglycerides)
Time frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes of glycemia values
Time frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes of HbA1C values
Time frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes of albuminemia values
Time frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes of insulinemia values
Time frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Changes of creatinemia values
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Time frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Change in the body composition analysis with segmental analysis
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
Time frame: 1 month, 6 months, 12 months after surgery
Change in the qualitative evaluation of physical activity.
Daily physical activity will be evaluated by a self-questionary (IPAQ)
Time frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Change in the quantitative evaluation of physical activity.
Daily physical activity will be evaluated by accelerometer measurements.
Time frame: 1 month, 6 months and 12 months after surgery
Sub-maximal stress testing
Time frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Change in the quantitative evaluation of the sleep quality
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.
Time frame: Before and 12 months after surgery
Change in the qualitative evaluation of the sleep quality
Comparison of the sleep quality by the mean of a visual analogic scale in a sleep diary
Time frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Change in the energy balance
Energy balance analysis (energy intake vs energy expenditure) and detailed nutriments analysis.
Time frame: 1 month, 6 months, 12 months after surgery
Change in the 6 min Walking test
Determination of the maximal walking distance performed by the patient after a 6 minutes walk
Time frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Change in the quantitative self esteem evaluation
Rosenberg questionary for the evaluation of Self-esteem
Time frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery
Change in the quantitative evaluation of the health related quality of life
Medical Outcome Study Short Form-36 (MOS SF-36) questionary
Time frame: 1 month, 3 months, 6 months, 9 months and 12 months after surgery