Study of Multi-site Neuromuscular Electrical Stimulation to Increase Spontaneous Physical Activity in Obesity Patient Carrying Severe Inactive: Randomized Controlled Trial vs Placebo
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 73
- Locations
- 3
- Primary Endpoint
- Change in physical activity
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
Obesity and sleep apnea syndrome lead to metabolic troubles and increasing cardiovascular risk. Furthermore, both diseases are associated with reduced exercise tolerance. For many patients with morbid obesity, the implementation of physical activity programs remains difficult for several reasons including the level of disability and psychosocial causes (the scrutiny of others, depression and poorly adapted equipment). Main hypothesis: Neuromuscular electrostimulation is a way to increase spontaneous physical activity (PA) in treated apneic obese patients with low spontaneous physical activity
Investigators
Eligibility Criteria
Inclusion Criteria
- •Obese patients with BMI \> 35 kg/m²
- •Continuous Positive Airway Pressure (CPAP) treatment and \> 4h observance per night to the patient with OSAS (obstructive sleep apnoea syndrome)
- •Patients who give written consent
- •Patients who subscribed social insurance
Exclusion Criteria
- •Cardiovascular or respiratory failure discovered at the moment of the inclusion in the study
- •Contraindication to exercise
- •Pregnant or breast-feed woman
- •Patients under guardianship
- •Imprisoned patients
Outcomes
Primary Outcomes
Change in physical activity
Time Frame: After a period of monthly supervised training program by neuromuscular electrical stimulation at home (12th wk)
* Number of steps per day * Number of MET (metabolic equivalent of task) per day
Secondary Outcomes
- Change in arterial stiffness(After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week))
- Change in quality of life(After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week ))
- Change in other parameters of physical activity(After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week))
- Change in plasmatic biomarkers(After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week ))
- Number of cardiovascular events per year(Every year from the 1st to the 2th year)
- Change in sleep quality(After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week))
- Changes in body composition(After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week))
- Change in endothelial function(After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week ))