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Study of Neuromuscular Electrical Stimulation to Increase Spontaneous Physical Activity in Obesity Patient

University Hospital, Grenoble · 2014
ClinicalTrials.gov · Datasets · License: Public Domain · 2014
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naobesity
The study was designed to test the following hypotheses: Main Objective: To compare the level of spontaneous physical activity at 3 months after re-entrainment by multi-site electrical stimulation (m-ES), measured by actigraphy over 7 days, compared to conventional care (lifestyle and dietary advice and placebo (simulated) electrostimulation) (control arm). Secondary Objectives: To compare the metabolic, inflammatory, cardiovascular and functional parameters, physical activity, quality of life and quality of sleep, at 3 months and at 2 years in the two groups. Design: We will conduct a multicenter controlled study vs. reference care with randomization into two parallel groups and double-blind (placebo electrostimulation). Patients will have the ES material available at home and will be supervised by monthly visits over 3 months and by telephone follow-up for two years. The study size calculation is based on physical activity, the percentage of lean body mass and arterial stiffness measured in the OBEX study (NCT01155271). This project will determine whether the training strategy is effective for increasing physical activity and/or in inducing significant metabolic and cardiovascular effects in these patients after 2 years. In addition, it provides a solid base of investigation for the study of the interactions between muscle contraction and cardio-metabolic health with greater precision.
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