The Effect of Combined Thermal and Electrical Muscle Stimulation (cTEMS) on Obesity
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Dec 2010
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 25, 2012
CompletedFirst Posted
Study publicly available on registry
February 2, 2012
CompletedFebruary 2, 2012
January 1, 2012
4 months
January 25, 2012
January 31, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Oxygen uptake
Baseline and after 10 weeks
Secondary Outcomes (3)
Lipolytic activity
Baseline and after 10 weeks
Gene expression in adipose tissue
Baseline and after 10 weeks
Body composition
Baseline and after 10 weeks
Study Arms (1)
Active
EXPERIMENTALcTEMS
Interventions
cTEMS in three 60-minute sessions per week for 8 weeks
Eligibility Criteria
You may qualify if:
- Obese (Body mass index; BMI ≥ 30 kg/m2),
- sedentary subjects (\< 20 minutes of exercise \< 3 days per week).
- the ability to undergo exercise testing.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Haukeland University Hospitallead
- University of Bergencollaborator
Study Sites (1)
Haukeland University Hospital
Bergen, 5009, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jan Erik Nordrehaug, PhD
University of Bergen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2012
First Posted
February 2, 2012
Study Start
December 1, 2010
Primary Completion
April 1, 2011
Study Completion
May 1, 2011
Last Updated
February 2, 2012
Record last verified: 2012-01