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

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ClinicalTrials.gov Identifier: NCT02210585
Recruitment Status : Recruiting
First Posted : August 6, 2014
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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.

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.


Condition or disease Intervention/treatment Phase
Obesity Number of Steps Per Day < 7000 Other: Rehabilitation Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 9, 2014
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)


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)





Primary Outcome Measures :
  1. 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 METs per day


Secondary Outcome Measures :
  1. Changes in body composition [ Time Frame: 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) ]
    Fat mass and fat-mass index as assessed by impedancemetry measurements

  2. Change in arterial stiffness [ Time Frame: 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) ]
    Pulse wave velocity

  3. Change in endothelial function [ Time Frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week ) ]
    Peripheral arterial tone (RH-PAT)

  4. Change in plasmatic biomarkers [ Time Frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week ) ]
    Oxidative stress and inflammatory blood parameters

  5. Change in quality of life [ Time Frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week ) ]
    SF-12 questionnaire

  6. Number of cardiovascular events per year [ Time Frame: Every year from the 1st to the 2th year ]
    Questionnaire sent to the patient by mail

  7. Change in other parameters of physical activity [ Time Frame: 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) ]
    Energy expenditure (total and during daily activities)

  8. Change in sleep quality [ Time Frame: 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) ]
    Lying and sleep duration



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obese patients with BMI > 35 kg/m²
  • CPAP treatment and > 4h observance per night to the patient with SAS
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210585


Contacts
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Contact: Renaud TAMISIER, Pr 0476768469 RTamisier@chu-grenoble.fr
Contact: Isabelle VIVODTZEV, PhD 0668133401 i.vivodtzev@agiradom.com

Locations
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France
Hôpital Universitaire de Grenoble Recruiting
Grenoble, France, 38043
Contact: Renaud TAMISIER, Pr    0476768469    RTamisier@chu-grenoble.fr   
Contact: Isabelle VIVODTZEV, PhD    0668133401    i.vivodtzev@agiradom.com   
Hôpital universitaire de Lyon Not yet recruiting
Lyon, France, 69310
Contact: Martine LAVILLE, Pr    04 78 86 29 81    martine.laville@chu-lyon.fr   
Contact: Isabelle VIVODTZEV, PhD    0668133401    i.vivodtzev@agiradom.com   
Hôpital universitaire de Saint Etienne Recruiting
Saint Etienne, France, 42055
Contact: Frederic ROCHE, Dr    04 77 82 83 00    Frederic.Roche@univ-st-etienne.fr   
Contact: Isabelle VIVODTZEV, PhD    0668133401    i.vivodtzev@agiradom.com   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Renaud TAMISIER, Pr Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02210585     History of Changes
Other Study ID Numbers: 38RC13.554
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms