Effects of Electrostimulation on Glycemic Control in Obesity
Condition: Obesity Adult Onset
MeSH terms: Obesity
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Muscle Electrostimulation
Intervention type(s): Device
Intervention description(s): 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
Other intervention name(s): Compex Pro Rehab ®; 253311x - REF 201010
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Monocentric; prospective; opened ; randomized; controlled study
Distribution of patients in groups according to a ratio (1: 1)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: muscle electrostimulation; diabetes; endocrinology; physical activity; quality of life; obesity