Adapted Physical Activity Program After Sleeve Gastrectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of an Adapted Physical Activity Program on Health and Physical Condition After Sleeve Gastrectomy

Conditions
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Obesity

Intervention / Treatment
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* Other: Personalized Physical Activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized Physical Activity<br>Patients will undergo a personalized physical activity program after sleeve gastrectomy. | Other: Personalized Physical Activity<br>* 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.<br>|
| No Intervention: Regular Activity<br>Patients will have regular physical activity after sleeve gastrectomy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 month, 6 months, 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in systolic blood pressure |  | 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). | 1 month, 3 months, 6 months, 9 months and 12 months after surgery | 
| Changes in the lipid profile | (total cholesterol, LDL HDL, Triglycerides) | 1 month, 3 months, 6 months, 9 months and 12 months after surgery | 
| 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 | 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 | 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) | 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. | 1 month, 6 months and 12 months after surgery | 
| 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 | 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. | 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 | 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. | 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 | 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 | 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 | 1 month, 3 months, 6 months, 9 months and 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fat mass, Lean mass, Obesity, Sleeve gastrectomy, Personalized physical activity program, Body Composition