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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01524952
• Other study ID #: 2009/1273
• Status: Completed
• Phase: N/A
• First received: January 25, 2012
• Last updated: January 31, 2012
• Start date: December 2010
• Est. completion date: May 2011

Study information

• Verified date: January 2012
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• combined thermal and electrical muscle stimulation (cTEMS)
cTEMS in three 60-minute sessions per week for 8 weeks

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen uptake		Baseline and after 10 weeks	No
Secondary	Lipolytic activity	Lipolytic activity in adipose tissue measured by microdialysis	Baseline and after 10 weeks	No
Secondary	Gene expression in adipose tissue		Baseline and after 10 weeks	No
Secondary	Body composition	Body composition by DEXA	Baseline and after 10 weeks	No