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

Study of Multi-site Neuromuscular Electrical Stimulation to Increase Spontaneous Physical Activity in Obesity Patient Carrying Severe Inactive: Randomized Controlled Trial vs Placebo

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Number of Steps Per Day < 7000
• Intervention / Treatment: Other: Rehabilitation

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

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Hôpital Universitaire de Grenoble
  • Lyon, France, 69310
    • Hôpital universitaire de Lyon
  • Saint Etienne, France, 42055
    • Hôpital universitaire de Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 5 sessions per week	Other: Rehabilitation; 12 weeks : 5 sessions per week (1 supervised session at home every month) 92 weeks : spontaneous training (supervised by phone every month)
Active Comparator: Kneehab®; 5 sessions per week	Other: Rehabilitation; 12 weeks : 5 sessions per week (1 supervised session at home every month) 92 weeks : spontaneous training (supervised by phone every month)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical activity	Number of steps per day; Number of MET (metabolic equivalent of task) per day	After a period of monthly supervised training program by neuromuscular electrical stimulation at home (12th wk)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in body composition	Fat mass and fat-mass index as assessed by impedancemetry measurements	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 arterial stiffness	Pulse wave velocity	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	Peripheral arterial tone (RH-PAT)	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 plasmatic biomarkers	Oxidative stress and inflammatory blood parameters	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 quality of life	SF-12 questionnaire	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	Questionnaire sent to the patient by mail	Every year from the 1st to the 2th year
Change in other parameters of physical activity	Energy expenditure (total and during daily activities)	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 sleep quality	Lying and sleep duration	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)

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Renaud TAMISIER, Pr, Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2014
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: August 5, 2014
• First Submitted That Met QC Criteria: August 5, 2014
• First Posted (Estimated): August 6, 2014

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 38RC13.554