This study evaluate the effects of muscle electrostimulation (MES) on carbohydrate homeostasis in adult patients with obesity. Its aims are also to evaluate the tolerance of feasibilty and the tolerance of MES and the impact on basal metabolism ; muscle mass (maintenance, gain or loss) in a context of calorie restriction ; physical capacities ; adherence to the usual rehabilitation program ; eating behavior : quality of life.
Prevalence of adult obesity in general french population (≈15%) justifies the implementation of innovative care. Prescribing regular physical activity is one of the recommendations for managing obesity. However, patients find it difficult because of non-adapted offered activities; non-achievement concrete results despite the effort; difficulties to manage activities and to plan objective. Situation is seen as a failure and discourages patients. In addition, the obese patient may suffer from orthopedic disorders, cardiovascular contraindications, and the excessive weight in itself may force him to become sedentary. The recommendations on the practice of physical activity in the overall management of obesity are therefore not always applicable. Muscle electrostimulation (MES) could therefore be an interesting additional tool in the management of obesity and particularly of glycemic control in obese patients suffering from type 2 diabetes. Studies are still relatively few and present certain limits (small samples, short period of MES, very specific populations, few parameters evaluated, lack of consensus on the methods of MES, etc.). The results are nevertheless encouraging and call for the implementation of additional studies. Investigators therefore propose a controlled, randomized, single-center study in a group of 60 adult patients suffering from severe or morbid obesity (BMI\> = 35) in a 3-week rehabilitation stay. The aims are to establish whether MES is a possible and interesting tool in the management of obesity, by checking the following hypotheses: * control of carbohydrate metabolism is better when a MES is implemented; * MES sessions improve patients' physical capacities and / or their tolerance to exercise; * MES improves the quality of life of patients; * MES improves patient adherence to the usual nutritional rehabilitation program; * MES sessions are well tolerated and the accepted intensity nevertheless guarantees sufficient muscle stimulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
* Scheduled sessions of 20 minutes per day; 5 days a week * In physiotherapy or in their room for the most dependent patients * Installation and monitoring by a physiotherapist or by the trained clinical research nurse * Modalities: * Device program n ° 1: 20mn (2mn of warm-up, 15mn of work at 75hz, then 3mn of recovery) * 4 electrodes (2 per thigh): large model (5 \* 10 cm) for better comfort - Dura-Stick Plus model (reference 42200) * Gradual auto-increase of the intensity to the highest possible value tolerated, nevertheless allowing a contraction
CF Center - Fondation Ildys Site de Perharidy
Roscoff, France
Carbohydrate balance
Evaluation of the time spent (%) above / in / below the patient's glycemic targets measured with a "Free Style" glycemic holter
Time frame: Continuous measurement over the entire stay (Day 1 to Day 21)
Homa Index
Insulin resistance assessment
Time frame: Change from baseline (Day 1) to week 3 (Day 21)
Quicki Index
Insulin sensitivity assessment
Time frame: Change from baseline (Day 1) to week 3 (Day 21)
Blood Glucose Levels
Evaluation of the glucose levels (average, minimum, maximum)
Time frame: Continuous measurement over the entire stay (Day 1 to Day 21)
Postprandial blood glucose
Assessment of the number of postprandial hyper and hypoglycemia
Time frame: Continuous measurement over the entire stay (Day 1 to Day 21)
Basal blood metabolism
Blood chemistry analysis (lipid balance)
Time frame: Change from baseline (Day 2) to week 3 (Day 21)
Impedance
Bioelectrical impedance analysis of body composition
Time frame: Change from baseline (Day 2) to week 3 (Day 20)
Maximal voluntary force
Measurement of the maximum voluntary strength and endurance of the quadriceps
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Time frame: Change from baseline (Day 2) to week 3 (Day 21)
Six-minutes walk test (6MWT)
Measurement of the distance traveled during the 6MWT
Time frame: Change from baseline (Day 1) to week 3 (Day 20)
"Ricci & Gagnon" questionnaire
Assessment of the level of physical activities and sedentary lifestyle
Time frame: Change from baseline (Day 2) to week 3 (Day 21)
Adherence to the rehabilitation program
Evaluation of the number of performed sessions compared to the expected for the proposed activities (collective balneotherapy, individual balneotherapy, supervised adapted physical activities, independent nordic walking) with analysis of the reasons for the differences
Time frame: Evaluation at each sessions from Day 1 to Day 21
Anthropometry
Weight (Kg) and height (cm) will be combined to report BMI in kg/m2
Time frame: Change from baseline (Day 1) to week 3 (Day 21)
Quality of life, obesity and dietetics (QOLOD) rating scale
Evaluation of quality of life - This scale gives 5 sub-scores ranging from 0 (worse outcome) to 100 (better outcome) for each explored dimension.
Time frame: Change from baseline (Day 1) to week 3 (Day 21)
Visual analog pain scale
Assessment of pain intensity during MES sessions with a visual analog scale
Time frame: Evaluation at each sessions from Day 2 to Day 20
MES sessions check
Record of session criteria (duration, program, maximum intensity, contraction Y/N)
Time frame: Change from baseline (Day 1) to week 3 (Day 21)