NCT02210585Completed
Study of Neuromuscular Electrical Stimulation to Increase Spontaneous Physical Activity in Obesity Patient
Study of Multi-site Neuromuscular Electrical Stimulation to Increase Spontaneous Physical Activity in Obesity Patient Carrying Severe Inactive: Randomized Controlled Trial vs Placebo
Source: ClinicalTrials.gov · Last updated 16 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 73 (actual)
- First submitted
- 5 Aug 2014
- Start date
- 9 Apr 2014
- Primary completion date
- May 2024
- Lead sponsor
- University Hospital, Grenoble
- Diseases
- Obesity
- NCT number
- NCT02210585
What you commit to
- Study type: Interventional
- Participants enrolled: 73
- From 9 Apr 2014 to the primary completion date, May 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cardiovascular or respiratory failure discovered at the moment of the inclusion in the study
Other
- Contraindication to exercise
- Pregnant or breast-feed woman
- Patients under guardianship
- Imprisoned patients
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Universitaire de Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Hôpital universitaire de Lyon Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hôpital universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.