CF Center - Fondation Ildys Site de Perharidy
Roscoff, 29684, France
NCT Number: NCT04643899
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Roscoff, 29684, France
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Compex Pro Rehab ®, 253311x - REF 201010
Time frame: 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
Time frame: Change from baseline (Day 1) to week 3 (Day 21)
Insulin resistance assessment
Time frame: Change from baseline (Day 1) to week 3 (Day 21)
Insulin sensitivity assessment
Time frame: Continuous measurement over the entire stay (Day 1 to Day 21)
Evaluation of the glucose levels (average, minimum, maximum)
Time frame: Continuous measurement over the entire stay (Day 1 to Day 21)
Assessment of the number of postprandial hyper and hypoglycemia
Time frame: Change from baseline (Day 2) to week 3 (Day 21)
Blood chemistry analysis (lipid balance)
Time frame: Change from baseline (Day 2) to week 3 (Day 20)
Bioelectrical impedance analysis of body composition
Time frame: Change from baseline (Day 2) to week 3 (Day 21)
Measurement of the maximum voluntary strength and endurance of the quadriceps
Time frame: Change from baseline (Day 1) to week 3 (Day 20)
Measurement of the distance traveled during the 6MWT
Time frame: Change from baseline (Day 2) to week 3 (Day 21)
Assessment of the level of physical activities and sedentary lifestyle
Time frame: Evaluation at each sessions from Day 1 to Day 21
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: Change from baseline (Day 1) to week 3 (Day 21)
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)
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: Evaluation at each sessions from Day 2 to Day 20
Assessment of pain intensity during MES sessions with a visual analog scale
Time frame: Change from baseline (Day 1) to week 3 (Day 21)
Record of session criteria (duration, program, maximum intensity, contraction Y/N)
Fondation Ildys
Other
Evaluation of the Effects of Electrical Muscle Stimulation on Carbohydrate Homeostasis in Adult Patients With Obesity
Acronym: ElectrOBA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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