NCT04643899

Effects of Electrostimulation on Glycemic Control in Obesity

Evaluation of the Effects of Electrical Muscle Stimulation on Carbohydrate Homeostasis in Adult Patients With Obesity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Fondation Ildys · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity Adult Onset

Interventions

Type	Name	Description
DEVICE	Muscle Electrostimulation	* 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

Timeline

• Start date: 2021-03-29
• Primary completion: 2023-03-01
• Completion: 2023-07-19
• First posted: 2020-11-25
• Last updated: 2023-09-13

Locations

1 site across 1 country: France