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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
combined thermal and electrical muscle stimulation (cTEMS)
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haukeland University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active

Arm Description

cTEMS

Outcomes

Primary Outcome Measures

Oxygen uptake

Secondary Outcome Measures

Lipolytic activity
Lipolytic activity in adipose tissue measured by microdialysis
Gene expression in adipose tissue
Body composition
Body composition by DEXA

Full Information

First Posted
January 25, 2012
Last Updated
January 31, 2012
Sponsor
Haukeland University Hospital
Collaborators
University of Bergen
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1. Study Identification

Unique Protocol Identification Number
NCT01524952
Brief Title
The Effect of Combined Thermal and Electrical Muscle Stimulation (cTEMS) on Obesity
Official Title
The Effect of Combined Thermal and Electrical Muscle Stimulation (cTEMS) on Cardiorespiratory Fitness and Adipose Tissue in Obese Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
University of Bergen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
cTEMS
Intervention Type
Device
Intervention Name(s)
combined thermal and electrical muscle stimulation (cTEMS)
Intervention Description
cTEMS in three 60-minute sessions per week for 8 weeks
Primary Outcome Measure Information:
Title
Oxygen uptake
Time Frame
Baseline and after 10 weeks
Secondary Outcome Measure Information:
Title
Lipolytic activity
Description
Lipolytic activity in adipose tissue measured by microdialysis
Time Frame
Baseline and after 10 weeks
Title
Gene expression in adipose tissue
Time Frame
Baseline and after 10 weeks
Title
Body composition
Description
Body composition by DEXA
Time Frame
Baseline and after 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Erik Nordrehaug, PhD
Organizational Affiliation
University of Bergen
Official's Role
Study Chair
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5009
Country
Norway

12. IPD Sharing Statement

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

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