Clinical trial NCT02210585: Study of Neuromuscular Electrical Stimulation to Increase Spontaneous Physical Activity in Obesity Patient
Official title: Study of Multi-site Neuromuscular Electrical Stimulation to Increase Spontaneous Physical Activity in Obesity Patient Carrying Severe Inactive: Randomized Controlled Trial vs Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Number of Steps Per Day < 7000
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2014-08-06
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change in physical activity
timeFrame: After a period of monthly supervised training program by neuromuscular electrical stimulation at home (12th wk)
Secondary outcomes:
measure: Changes in body composition
timeFrame: 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)
measure: Change in arterial stiffness
timeFrame: 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)
measure: Change in endothelial function
timeFrame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week )
measure: Change in plasmatic biomarkers
timeFrame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week )
measure: Change in quality of life
timeFrame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week )
measure: Number of cardiovascular events per year
timeFrame: Every year from the 1st to the 2th year
measure: Change in other parameters of physical activity
timeFrame: 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)
measure: Change in sleep quality
timeFrame: 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)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Hôpital Universitaire de Grenoble
city: Lyon
country: France
facility: Hôpital universitaire de Lyon
city: Saint Etienne
country: France
facility: Hôpital universitaire de Saint Etienne
Study officials:
affiliation: Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
name: Renaud TAMISIER, Pr
role: PRINCIPAL_INVESTIGATOR
References: