- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02110927
Microcurrent and Aerobic Exercise Effects in Abdominal Fat
Microcurrent and Aerobic Exercise Effects in Glycerol, Catecholamines, Energetic Source and Muscle Activity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Nutritional patterns have been changed during twenty-first century with sugar and fat's high proportions that allied to sedentary lifestyle increased body fat. There is already a well establish relationship between total body fat excess, cardiometabolic diseases and increased mortality, knowing that abdominal fat (android pattern), different from body index, presents an additional influence to health risks. Women with their abdominal adipocytes (visceral fat) show an increased lipolytic activity that releases free fat acids to the systemic and portal circulation leading to a metabolic syndrome, increasing the risk of cardiovascular diseases.
Aerobic exercise is a way to decrease fat as it stimulates lipolysis through an increase in catecholamine's level resulting from a sympathetic system nervous activity raise. The most used exercise for lipid elimination is the prolonged aerobic moderate exercise with a minimum of 30 minutes.
Nevertheless aerobic exercise practice reduce globally lipidic sources and not locally .
Electrolipolysis using microcurrent has been used in clinical practice as a technique to reduce abdominal fat. This technique can be applied transcutaneously or percutaneously seeming that the former is not so effective as skin can be an obstacle to the current effect on visceral and subcutaneous fat .
Abdominal fat excess is associated with cardiometabolic diseases and can be prevented using microcurrent and aerobic exercise to stimulate lipolysis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Porto
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Vila Nova de Gaia, Porto, Portugal, 4400-303
- Andreia Noites
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age between 18 and 30 years.
Exclusion Criteria:
- submitted to other fat reduce procedure, to show cardiovascular risk factors or diseases and/or any physical condition limiting aerobic exercise. To present any contraindications to microcurrent and/or aerobic exercise, to take medication that influence lipid metabolism, and to be pregnant.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transcutaneous microcurrent
This group performed aerobic exercise just after microcurrent in the abdominal region with four transcutaneous electrodes in a parallel position, intensity below the sensitivity threshold and a maximum of 1 milliampere (mA).
Every 20 minutes changed from 25 hertz (Hz) to 10 Hz
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Microcurrent in the abdominal region with four transcutaneous electrodes in a parallel position, intensity below the sensitivity threshold and a maximum of 1 mA.
Every 15 minutes changed from 25 Hz to 10 Hz.
50 minutes of aerobic moderate-intensity exercise (45-55% of maximal oxygen consumption (VO2 max)) using Karvonen´s formula, performed on a cycloergometer.
Were used Borg scale (12-13), Polar® heart monitors to control heart rate and K4b2 to analyze the quantity of oxygen (O2) consumption and carbon dioxide (CO2) produced during exercise.
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Placebo Comparator: Control group
Control group performed aerobic exercise just after microcurrent in the abdominal region with four transcutaneous electrodes in a parallel position, but microcurrent device was switched off.
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50 minutes of aerobic moderate-intensity exercise (45-55% of maximal oxygen consumption (VO2 max)) using Karvonen´s formula, performed on a cycloergometer.
Were used Borg scale (12-13), Polar® heart monitors to control heart rate and K4b2 to analyze the quantity of oxygen (O2) consumption and carbon dioxide (CO2) produced during exercise.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in catecholamines and glycerol concentrations
Time Frame: 10 minutes before the interventions, after interventions (duration of interventions - 90 minutes) and after 24 hours
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Blood analysis collection was carried out with help from an clinical analysis technician.
The volunteers were not fasting.
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10 minutes before the interventions, after interventions (duration of interventions - 90 minutes) and after 24 hours
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Change in proportion of energy source
Time Frame: Immediately before (for 3 minutes) and during exercise (duration of exercise - 50 minutes)
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K4b2 (COSMED ®) was used for analysis of cardiopulmonary gas exchange in real time.
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Immediately before (for 3 minutes) and during exercise (duration of exercise - 50 minutes)
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Change in electromyographic activity
Time Frame: 5 minutes before and after microcurrent
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Recording the surface electrical activity produced by rectus abdominis and external oblique in front bridge and side bridge exercise, respectively.
|
5 minutes before and after microcurrent
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subcutaneous abdominal fat and visceral abdominal fat
Time Frame: 20 minutes before the interventions
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Ultrasound was performed at the end of expiration to measure subcutaneous abdominal fat between xiphoid apophysis and navel, below navel, and above left and right anterior superior iliac spine.
Between xiphoid apophysis and navel was also measured visceral abdominal fat.
Abdominal fat analyzed by dual-energy x-ray absorptiometry (DEXA).
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20 minutes before the interventions
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Suprailiac, vertical and horizontal abdominal skinfolds
Time Frame: 20 minutes before the interventions
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Suprailiac, vertical and horizontal abdominal skinfolds were performed two times in right hemi body, by caliper.
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20 minutes before the interventions
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Perimeters measurements
Time Frame: 20 minutes before the interventions
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The perimeters measurements were done, at the end of expiration, at waist level (below last rib), at navel level, at the point immediately above the iliac crests and at trochanters level. The waist-hip ratio was calculated using the waist level perimeter. divided by trochanters level perimeter. |
20 minutes before the interventions
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Change in cholesterol, triglycerides and glucose concentrations
Time Frame: 10 minutes before the interventions, after interventions (duration of interventions - 90 minutes)
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Blood analysis collection was carried out with help from an clinical analysis technician.
The volunteers were not fasting.
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10 minutes before the interventions, after interventions (duration of interventions - 90 minutes)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
International Physical Activity Questionnaire
Time Frame: 30 minutes before the interventions
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Used to evaluate the level of physical activity of the volunteers
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30 minutes before the interventions
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Food Frequency Questionnaire
Time Frame: 30 minutes before the interventions
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Used to evaluate the lifestyle of the volunteers
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30 minutes before the interventions
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Bioimpedance values
Time Frame: 30 minutes before the interventions
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The height was measured with the volunteers on respiratory apnea.
To minimize the influence of electrolyte balance changes in bioimpedance assessment, was given some rules to volunteers.
It was calculated BMI using the body weight divided by height squared
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30 minutes before the interventions
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Collaborators and Investigators
Investigators
- Study Chair: Rui Vilarinho, BSc, Escola Superior de Tecnologia da Saúde do Porto
Publications and helpful links
General Publications
- Ahmadian M, Wang Y, Sul HS. Lipolysis in adipocytes. Int J Biochem Cell Biol. 2010 May;42(5):555-9. doi: 10.1016/j.biocel.2009.12.009. Epub 2009 Dec 16.
- Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.
- Bulow J, Gjeraa K, Enevoldsen LH, Simonsen L. Lipid mobilization from human abdominal, subcutaneous adipose tissue is independent of sex during steady-state exercise. Clin Physiol Funct Imaging. 2006 Jul;26(4):205-11. doi: 10.1111/j.1475-097X.2006.00664.x.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AN-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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