Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB | Other Identifier | 2020-A00484-35 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lille Catholic University | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Patients benefiting only from the usual nutritional rehabilitation program G1a: diabetic patients G1b: non-diabetic patients | |
| Electrostimulation group | Experimental | Patients benefiting from the usual program AND muscle electrostimulation sessions G2a: diabetic patients G2b: non-diabetic patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Muscle Electrostimulation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Carbohydrate balance | Evaluation of the time spent (%) above / in / below the patient's glycemic targets measured with a "Free Style" glycemic holter | Continuous measurement over the entire stay (Day 1 to Day 21) |
| Measure | Description | Time Frame |
|---|---|---|
| Homa Index | Insulin resistance assessment | Change from baseline (Day 1) to week 3 (Day 21) |
| Quicki Index | Insulin sensitivity assessment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lena SEITE, MD | Fondation Ildys | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CF Center - Fondation Ildys Site de Perharidy | Roscoff | 29684 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23368829 | Background | Grosset JF, Crowe L, De Vito G, O'Shea D, Caulfield B. Comparative effect of a 1 h session of electrical muscle stimulation and walking activity on energy expenditure and substrate oxidation in obese subjects. Appl Physiol Nutr Metab. 2013 Jan;38(1):57-65. doi: 10.1139/apnm-2011-0367. Epub 2012 Nov 12. | |
| 25734937 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009043 | Motor Activity |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Change from baseline (Day 1) to week 3 (Day 21) |
| Blood Glucose Levels | Evaluation of the glucose levels (average, minimum, maximum) | Continuous measurement over the entire stay (Day 1 to Day 21) |
| Postprandial blood glucose | Assessment of the number of postprandial hyper and hypoglycemia | Continuous measurement over the entire stay (Day 1 to Day 21) |
| Basal blood metabolism | Blood chemistry analysis (lipid balance) | Change from baseline (Day 2) to week 3 (Day 21) |
| Impedance | Bioelectrical impedance analysis of body composition | Change from baseline (Day 2) to week 3 (Day 20) |
| Maximal voluntary force | Measurement of the maximum voluntary strength and endurance of the quadriceps | Change from baseline (Day 2) to week 3 (Day 21) |
| Six-minutes walk test (6MWT) | Measurement of the distance traveled during the 6MWT | Change from baseline (Day 1) to week 3 (Day 20) |
| "Ricci & Gagnon" questionnaire | Assessment of the level of physical activities and sedentary lifestyle | 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 | 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 | 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. | 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 | Evaluation at each sessions from Day 2 to Day 20 |
| MES sessions check | Record of session criteria (duration, program, maximum intensity, contraction Y/N) | Change from baseline (Day 1) to week 3 (Day 21) |
| van Buuren F, Horstkotte D, Mellwig KP, Frund A, Vlachojannis M, Bogunovic N, Dimitriadis Z, Vortherms J, Humphrey R, Niebauer J. Electrical Myostimulation (EMS) Improves Glucose Metabolism and Oxygen Uptake in Type 2 Diabetes Mellitus Patients--Results from the EMS Study. Diabetes Technol Ther. 2015 Jun;17(6):413-9. doi: 10.1089/dia.2014.0315. Epub 2015 Mar 3. |
| 25107502 | Background | Joubert M, Metayer L, Prevost G, Morera J, Rod A, Cailleux A, Parienti JJ, Reznik Y. Neuromuscular electrostimulation and insulin sensitivity in patients with type 2 diabetes: the ELECTRODIAB pilot study. Acta Diabetol. 2015 Apr;52(2):285-91. doi: 10.1007/s00592-014-0636-5. Epub 2014 Aug 9. |
| 22296854 | Background | Miyamoto T, Fukuda K, Kimura T, Matsubara Y, Tsuda K, Moritani T. Effect of percutaneous electrical muscle stimulation on postprandial hyperglycemia in type 2 diabetes. Diabetes Res Clin Pract. 2012 Jun;96(3):306-12. doi: 10.1016/j.diabres.2012.01.006. Epub 2012 Jan 30. |
| 28194410 | Background | Vivodtzev I, Maffiuletti NA, Borel AL, Grangier A, Wuyam B, Tamisier R, Pepin JL. Acute Feasibility of Neuromuscular Electrical Stimulation in Severely Obese Patients with Obstructive Sleep Apnea Syndrome: A Pilot Study. Biomed Res Int. 2017;2017:3704380. doi: 10.1155/2017/3704380. Epub 2017 Jan 17. |
| D001519 | Behavior |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |