Evaluation of the Effects of Electrical Muscle Stimulation on Carbohydrate Homeostasis in Adult Patients With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Carbohydrate balance
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women over 18 years old and under 70 years old
- •with severe or morbid obesity (BMI> = 35)
- •with or without bariatric surgery
- •able to understand and respect the protocol and its requirement
- •who signed the consent prior to any other procedure protocol
排除标准
- •major patients under guardianship / curatorship / legal protection
- •pregnant patients
- •patients with epilepsy
- •with an implanted electronic/electrical device (cardiac pacemaker, intracardiac defibrillator, etc.)
- •with a baclofen pump
- •suffering from serious disorders of the arterial circulation in the lower limbs such as Peripheral Arterial Obstructive Disease (PAOD)
- •suffering from abdominal or inguinal hernia
- •suffering from cardiac arrhythmia
- •suffering from skin lesions and/or infections foci on one or more areas where the electrodes are placed
- •suffering from sensory disorders in the areas of stimulation
- •patients unable to complete the entire program
结局指标
主要结局
Carbohydrate balance
时间窗: Continuous measurement over the entire stay (Day 1 to Day 21)
Evaluation of the time spent (%) above / in / below the patient's glycemic targets measured with a "Free Style" glycemic holter
次要结局
- Quality of life, obesity and dietetics (QOLOD) rating scale(Change from baseline (Day 1) to week 3 (Day 21))
- Visual analog pain scale(Evaluation at each sessions from Day 2 to Day 20)
- Homa Index(Change from baseline (Day 1) to week 3 (Day 21))
- Quicki Index(Change from baseline (Day 1) to week 3 (Day 21))
- Impedance(Change from baseline (Day 2) to week 3 (Day 20))
- Maximal voluntary force(Change from baseline (Day 2) to week 3 (Day 21))
- Six-minutes walk test (6MWT)(Change from baseline (Day 1) to week 3 (Day 20))
- Blood Glucose Levels(Continuous measurement over the entire stay (Day 1 to Day 21))
- Postprandial blood glucose(Continuous measurement over the entire stay (Day 1 to Day 21))
- Basal blood metabolism(Change from baseline (Day 2) to week 3 (Day 21))
- "Ricci & Gagnon" questionnaire(Change from baseline (Day 2) to week 3 (Day 21))
- MES sessions check(Change from baseline (Day 1) to week 3 (Day 21))
- Adherence to the rehabilitation program(Evaluation at each sessions from Day 1 to Day 21)
- Anthropometry(Change from baseline (Day 1) to week 3 (Day 21))