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

NCT ID: NCT02210585

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-09
• Study Completion Date: 2024-05-31

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

Conditions

Obesity; Number of Steps Per Day < 7000

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Kneehab®

5 sessions per week

Group Type: ACTIVE_COMPARATOR

Rehabilitation

Intervention Type: OTHER

12 weeks : 5 sessions per week (1 supervised session at home every month)

92 weeks : spontaneous training (supervised by phone every month)

Placebo

5 sessions per week

Group Type: PLACEBO_COMPARATOR

Rehabilitation

Intervention Type: OTHER

12 weeks : 5 sessions per week (1 supervised session at home every month)

92 weeks : spontaneous training (supervised by phone every month)

Interventions

Rehabilitation

12 weeks : 5 sessions per week (1 supervised session at home every month)

92 weeks : spontaneous training (supervised by phone every month)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renaud TAMISIER, Pr

Role: PRINCIPAL_INVESTIGATOR

Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France

Locations

Hôpital Universitaire de Grenoble

Grenoble, , France

Hôpital universitaire de Lyon

Lyon, , France

Hôpital universitaire de Saint Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

38RC13.554

Identifier Type: -

Identifier Source: org_study_id