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OpenTrials
Completed

NCT Number: NCT01524952

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital

Bergen, 5009, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

combined thermal and electrical muscle stimulation (cTEMS)

Device

cTEMS in three 60-minute sessions per week for 8 weeks

Primary outcomes

  1. Oxygen uptake

    Time frame: Baseline and after 10 weeks

Secondary outcomes

  1. Lipolytic activity

    Time frame: Baseline and after 10 weeks

    Lipolytic activity in adipose tissue measured by microdialysis

  2. Gene expression in adipose tissue

    Time frame: Baseline and after 10 weeks

  3. Body composition

    Time frame: Baseline and after 10 weeks

    Body composition by DEXA

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • University of Bergen

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 2, 2012
Registry last updated
Feb 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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