Effects of Electrostimulation on Glycemic Control in Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-29

Study Completion Date

2023-07-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity Adult Onset

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

* Monocentric; prospective; opened ; randomized; controlled study
* Distribution of patients in groups according to a ratio (1: 1)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

Patients benefiting only from the usual nutritional rehabilitation program G1a: diabetic patients G1b: non-diabetic patients

Group Type NO_INTERVENTION

No interventions assigned to this group

Electrostimulation group

Patients benefiting from the usual program AND muscle electrostimulation sessions G2a: diabetic patients G2b: non-diabetic patients

Group Type EXPERIMENTAL

Muscle Electrostimulation

Intervention Type DEVICE

* 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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Compex Pro Rehab ® 253311x - REF 201010

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No