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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Device: combined thermal and electrical muscle stimulation (cTEMS)

• Registration Number: NCT01524952
• Lead Sponsor: Haukeland University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2011-04
• Study Completion: 2011-05
• Status Verified: 2012-01
• Study First Submitted: 2012-01-25
• Study First Submitted QC: 2012-01-31
• Last Update Submitted: 2012-01-31
• Study First Posted: 2012-02-02
• Last Update Posted: 2012-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active	combined thermal and electrical muscle stimulation (cTEMS)	cTEMS

Primary Outcome Measures

Name	Time	Method
Oxygen uptake	Baseline and after 10 weeks

Secondary Outcome Measures

Name	Time	Method
Lipolytic activity	Baseline and after 10 weeks	Lipolytic activity in adipose tissue measured by microdialysis
Gene expression in adipose tissue	Baseline and after 10 weeks
Body composition	Baseline and after 10 weeks	Body composition by DEXA

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway