The Effect of Combined Thermal and Electrical Muscle Stimulation (cTEMS) on Obesity

Study Overview
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Brief Summary
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Objective: It is unclear whether prolonged electrical muscle stimulation can improve cardiorespiratory fitness and reduce body fat in obese subjects. The purpose of this study is to investigate the effect of prolonged combined thermal and electrical muscle stimulation (cTEMS) on peak oxygen consumption (VO2 peak) and body composition. We will also investigate the biochemical effects and the resultant lipolysis-related gene expression changes in adipocytes. Methods:Eleven obese (BMI≥30) individuals will receive cTEMS in three 60-minute sessions per week for 8 weeks. Activity levels and dietary habits will be kept unchanged and controlled with an accelerometer and nutritional questionnaire. Before and after the stimulation period, functional capacity are assessed by VO2 peak, and body composition was assessed by dual-energy X-ray absorptiometry and bioelectrical impedance analyses. Lipolytic activity will be determined in abdominal adipose tissue by 24 hours of microdialysis on a sedentary day, and adipose tissue biopsies will be taken for the gene expression analysis.

Official Title
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The Effect of Combined Thermal and Electrical Muscle Stimulation (cTEMS) on Cardiorespiratory Fitness and Adipose Tissue in Obese Individuals

Conditions
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Obesity

Intervention / Treatment
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* Device: combined thermal and electrical muscle stimulation (cTEMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obese (Body mass index; BMI ≥ 30 kg/m2), sedentary subjects (< 20 minutes of exercise < 3 days per week). Other inclusion criteria were age between 30 and 70 years and the ability to undergo exercise testing. Exclusion Criteria: Pacemaker or implanted defibrillator, regular medication, cardiovascular disease, pulmonary disease, extensive dermatological disease or other primary diseases; pregnant women; and individuals who abuse alcohol or drugs were excluded from the study

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>cTEMS | Device: combined thermal and electrical muscle stimulation (cTEMS)<br>* cTEMS in three 60-minute sessions per week for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen uptake |  | Baseline and after 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipolytic activity | Lipolytic activity in adipose tissue measured by microdialysis | Baseline and after 10 weeks | 
| Gene expression in adipose tissue |  | Baseline and after 10 weeks | 
| Body composition | Body composition by DEXA | Baseline and after 10 weeks |