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

This study has been completed.
Sponsor:
Collaborator:
University of Bergen
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01524952
First received: January 25, 2012
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Device: combined thermal and electrical muscle stimulation (cTEMS)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Combined Thermal and Electrical Muscle Stimulation (cTEMS) on Cardiorespiratory Fitness and Adipose Tissue in Obese Individuals

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Oxygen uptake [ Time Frame: Baseline and after 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipolytic activity [ Time Frame: Baseline and after 10 weeks ] [ Designated as safety issue: No ]
    Lipolytic activity in adipose tissue measured by microdialysis

  • Gene expression in adipose tissue [ Time Frame: Baseline and after 10 weeks ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: Baseline and after 10 weeks ] [ Designated as safety issue: No ]
    Body composition by DEXA


Enrollment: 12
Study Start Date: December 2010
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
cTEMS
 Device: combined thermal and electrical muscle stimulation (cTEMS)
cTEMS in three 60-minute sessions per week for 8 weeks

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524952

Locations
Norway
Haukeland University Hospital
Bergen, Norway, 5009
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
Investigators
Study Chair: Jan Erik Nordrehaug, PhD University of Bergen
  More Information

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01524952     History of Changes
Other Study ID Numbers: 2009/1273
Study First Received: January 25, 2012
Last Updated: January 31, 2012
Health Authority: Norway: Regional Ethics Commitee

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013