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Effects of Electrostimulation on Glycemic Control in Obesity (ElectrOBA)

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ClinicalTrials.gov Identifier: NCT04643899
Recruitment Status : Not yet recruiting
First Posted : November 25, 2020
Last Update Posted : November 25, 2020
Sponsor:
Collaborator:
Lille Catholic University
Information provided by (Responsible Party):
Fondation Ildys

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Adult Onset Device: Muscle Electrostimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • Monocentric; prospective; opened ; randomized; controlled study
  • Distribution of patients in groups according to a ratio (1: 1)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of Electrical Muscle Stimulation on Carbohydrate Homeostasis in Adult Patients With Obesity
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : June 1, 2023

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Homa Index [ Time Frame: Change from baseline (Day 1) to week 3 (Day 21) ]
    Insulin resistance assessment

  2. Quicki Index [ Time Frame: Change from baseline (Day 1) to week 3 (Day 21) ]
    Insulin sensitivity assessment

  3. Blood Glucose Levels [ Time Frame: Continuous measurement over the entire stay (Day 1 to Day 21) ]
    Evaluation of the glucose levels (average, minimum, maximum)

  4. 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

  5. Basal blood metabolism [ Time Frame: Change from baseline (Day 2) to week 3 (Day 21) ]
    Blood chemistry analysis (lipid balance)

  6. Impedance [ Time Frame: Change from baseline (Day 2) to week 3 (Day 20) ]
    Bioelectrical impedance analysis of body composition

  7. 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

  8. 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

  9. "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

  10. 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

  11. 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

  12. 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.

  13. 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

  14. 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)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04643899


Contacts
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Contact: Laetitia GUEGANTON, PhD 33-6-13-61-78-46 laetitia.gueganton@ildys.org
Contact: Marion BUYSE, MD 33-2-98-29-34-47 marion.buyse@ildys.org

Locations
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France
CF Center - Fondation Ildys Site de Perharidy
Roscoff, France, 29684
Sponsors and Collaborators
Fondation Ildys
Lille Catholic University
Investigators
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Principal Investigator: Lena SEITE, MD Fondation Ildys
Additional Information:
Publications:

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Responsible Party: Fondation Ildys
ClinicalTrials.gov Identifier: NCT04643899    
Other Study ID Numbers: ILDYS-ISC2-2020001
ID-RCB ( Other Identifier: 2020-A00484-35 )
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Ildys:
muscle electrostimulation
diabetes
endocrinology
physical activity
quality of life
obesity
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight