Effects of Electrostimulation on Glycemic Control in Obesity (ElectrOBA)

September 12, 2023 updated by: Fondation Ildys

Evaluation of the Effects of Electrical Muscle Stimulation on Carbohydrate Homeostasis in Adult Patients With Obesity

This study evaluate the effects of muscle electrostimulation (MES) on carbohydrate homeostasis in adult patients with obesity. Its aims are also to evaluate the tolerance of feasibilty and the tolerance of MES and the impact on basal metabolism ; muscle mass (maintenance, gain or loss) in a context of calorie restriction ; physical capacities ; adherence to the usual rehabilitation program ; eating behavior : quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prevalence of adult obesity in general french population (≈15%) justifies the implementation of innovative care. Prescribing regular physical activity is one of the recommendations for managing obesity. However, patients find it difficult because of non-adapted offered activities; non-achievement concrete results despite the effort; difficulties to manage activities and to plan objective. Situation is seen as a failure and discourages patients. In addition, the obese patient may suffer from orthopedic disorders, cardiovascular contraindications, and the excessive weight in itself may force him to become sedentary. The recommendations on the practice of physical activity in the overall management of obesity are therefore not always applicable.

Muscle electrostimulation (MES) could therefore be an interesting additional tool in the management of obesity and particularly of glycemic control in obese patients suffering from type 2 diabetes.

Studies are still relatively few and present certain limits (small samples, short period of MES, very specific populations, few parameters evaluated, lack of consensus on the methods of MES, etc.). The results are nevertheless encouraging and call for the implementation of additional studies.

Investigators therefore propose a controlled, randomized, single-center study in a group of 60 adult patients suffering from severe or morbid obesity (BMI> = 35) in a 3-week rehabilitation stay.

The aims are to establish whether MES is a possible and interesting tool in the management of obesity, by checking the following hypotheses:

  • control of carbohydrate metabolism is better when a MES is implemented;
  • MES sessions improve patients' physical capacities and / or their tolerance to exercise;
  • MES improves the quality of life of patients;
  • MES improves patient adherence to the usual nutritional rehabilitation program;
  • MES sessions are well tolerated and the accepted intensity nevertheless guarantees sufficient muscle stimulation.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Roscoff, France, 29684
        • CF Center - Fondation Ildys Site de Perharidy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • men and women over 18 years old and under 70 years old
  • with severe or morbid obesity (BMI> = 35)
  • with or without bariatric surgery
  • able to understand and respect the protocol and its requirement
  • who signed the consent prior to any other procedure protocol

Exclusion Criteria:

  • major patients under guardianship / curatorship / legal protection
  • pregnant patients
  • patients with epilepsy
  • with an implanted electronic/electrical device (cardiac pacemaker, intracardiac defibrillator, etc.)
  • with a baclofen pump
  • suffering from serious disorders of the arterial circulation in the lower limbs such as Peripheral Arterial Obstructive Disease (PAOD)
  • suffering from abdominal or inguinal hernia
  • suffering from cardiac arrhythmia
  • suffering from skin lesions and/or infections foci on one or more areas where the electrodes are placed
  • suffering from sensory disorders in the areas of stimulation
  • patients unable to complete the entire program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Patients benefiting only from the usual nutritional rehabilitation program G1a: diabetic patients G1b: non-diabetic patients
Experimental: Electrostimulation group
Patients benefiting from the usual program AND muscle electrostimulation sessions G2a: diabetic patients G2b: non-diabetic patients
Device: Muscle Electrostimulation
  • Scheduled sessions of 20 minutes per day; 5 days a week
  • In physiotherapy or in their room for the most dependent patients
  • Installation and monitoring by a physiotherapist or by the trained clinical research nurse

  • Modalities:

    • Device program n ° 1: 20mn (2mn of warm-up, 15mn of work at 75hz, then 3mn of recovery)
    • 4 electrodes (2 per thigh): large model (5 * 10 cm) for better comfort - Dura-Stick Plus model (reference 42200)
    • Gradual auto-increase of the intensity to the highest possible value tolerated, nevertheless allowing a contraction
Other Names:
  • Compex Pro Rehab ®
  • 253311x - REF 201010

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carbohydrate balance
Time Frame: Continuous measurement over the entire stay (Day 1 to Day 21)
Evaluation of the time spent (%) above / in / below the patient's glycemic targets measured with a "Free Style" glycemic holter
Continuous measurement over the entire stay (Day 1 to Day 21)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Homa Index
Time Frame: Change from baseline (Day 1) to week 3 (Day 21)
Insulin resistance assessment
Change from baseline (Day 1) to week 3 (Day 21)
Quicki Index
Time Frame: Change from baseline (Day 1) to week 3 (Day 21)
Insulin sensitivity assessment
Change from baseline (Day 1) to week 3 (Day 21)
Blood Glucose Levels
Time Frame: Continuous measurement over the entire stay (Day 1 to Day 21)
Evaluation of the glucose levels (average, minimum, maximum)
Continuous measurement over the entire stay (Day 1 to Day 21)
Postprandial blood glucose
Time Frame: Continuous measurement over the entire stay (Day 1 to Day 21)
Assessment of the number of postprandial hyper and hypoglycemia
Continuous measurement over the entire stay (Day 1 to Day 21)
Basal blood metabolism
Time Frame: Change from baseline (Day 2) to week 3 (Day 21)
Blood chemistry analysis (lipid balance)
Change from baseline (Day 2) to week 3 (Day 21)
Impedance
Time Frame: Change from baseline (Day 2) to week 3 (Day 20)
Bioelectrical impedance analysis of body composition
Change from baseline (Day 2) to week 3 (Day 20)
Maximal voluntary force
Time Frame: Change from baseline (Day 2) to week 3 (Day 21)
Measurement of the maximum voluntary strength and endurance of the quadriceps
Change from baseline (Day 2) to week 3 (Day 21)
Six-minutes walk test (6MWT)
Time Frame: Change from baseline (Day 1) to week 3 (Day 20)
Measurement of the distance traveled during the 6MWT
Change from baseline (Day 1) to week 3 (Day 20)
"Ricci & Gagnon" questionnaire
Time Frame: Change from baseline (Day 2) to week 3 (Day 21)
Assessment of the level of physical activities and sedentary lifestyle
Change from baseline (Day 2) to week 3 (Day 21)
Adherence to the rehabilitation program
Time Frame: Evaluation at each sessions from Day 1 to Day 21
Evaluation of the number of performed sessions compared to the expected for the proposed activities (collective balneotherapy, individual balneotherapy, supervised adapted physical activities, independent nordic walking) with analysis of the reasons for the differences
Evaluation at each sessions from Day 1 to Day 21
Anthropometry
Time Frame: Change from baseline (Day 1) to week 3 (Day 21)
Weight (Kg) and height (cm) will be combined to report BMI in kg/m2
Change from baseline (Day 1) to week 3 (Day 21)
Quality of life, obesity and dietetics (QOLOD) rating scale
Time Frame: Change from baseline (Day 1) to week 3 (Day 21)
Evaluation of quality of life - This scale gives 5 sub-scores ranging from 0 (worse outcome) to 100 (better outcome) for each explored dimension.
Change from baseline (Day 1) to week 3 (Day 21)
Visual analog pain scale
Time Frame: Evaluation at each sessions from Day 2 to Day 20
Assessment of pain intensity during MES sessions with a visual analog scale
Evaluation at each sessions from Day 2 to Day 20
MES sessions check
Time Frame: Change from baseline (Day 1) to week 3 (Day 21)
Record of session criteria (duration, program, maximum intensity, contraction Y/N)
Change from baseline (Day 1) to week 3 (Day 21)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ildys

Collaborators

Lille Catholic University

Investigators

  • Principal Investigator: Lena SEITE, MD, Fondation Ildys

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2021

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

July 19, 2023

Study Registration Dates

First Submitted

October 29, 2020

First Submitted That Met QC Criteria

November 19, 2020

First Posted (Actual)

November 25, 2020

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILDYS-ISC2-2020001
  • ID-RCB (Other Identifier: 2025-A02239-40)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity Adult Onset

Clinical Trials on Muscle Electrostimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe