- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01853761
Microcurrent and Aerobic Exercise Effects on Abdominal Fat
Study Overview
Status
Conditions
Detailed Description
Nutritional patterns have been changed during XXI century with sugar and fat's high proportions that allied to sedentarism 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 lipolitic 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 mn.
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
-
-
Porto
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Vila Nova de Gaia, Porto, Portugal, 4400-303
- Andreia Noites
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Vila Nova de Gaia, Porto, Portugal, 4400-330
- Andreia Noites
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age between 18 and 30 years
- presenting a normal to pre-obese body mass index (18.5 - 29.9 Kg/m2)
- moderate physical activity level (between 600 and 3000 metabolic-minute/week (MET-min/week)) scored by International Physical Activity Questionnaire (IPAQ)
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 contra indications 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: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise after, Transcutaneos, 25-10Hz
Experimental group 1 performed aerobic exercise just after microcurrent in the abdominal region with four transcutaneous electrodes in a parallel position, intensity below the sensivity threshold and a maximum of 1 mA.
Every 15 minutes changed from 25Hz to 10 Hz.
|
Aerobic exercise just after microcurrent in the abdominal region, intensity below the sensivity threshold and a maximum of 1 mA. 30 minutes of aerobic moderate-intensity exercise (50%VO2 max) using Karvonen´s formula, performed on a cycloergometer. Were used Borg scale (12-13) and Polar® heart monitors to control heart rate.
Other Names:
Microcurrent device in the abdominal region with four transcutaneous electrodes in a parallel position, intensity below the sensivity threshold and a maximum of 1 mA.
Other Names:
microcurrent device in the abdominal whith intensity below the sensivity threshold and a maximum of 1 mA.
Every 15 minutes changed from 25Hz to 10 Hz.
Other Names:
|
Experimental: 25-50Hz microcurrent
Experimental group 2 performed aerobic exercise just after microcurrent in the abdominal region with four transcutaneous electrodes in a parallel position, intensity below the sensivity threshold and a maximum of 1 mA.
Every 15 minutes changed from 25Hz to 50Hz.
|
Aerobic exercise just after microcurrent in the abdominal region, intensity below the sensivity threshold and a maximum of 1 mA. 30 minutes of aerobic moderate-intensity exercise (50%VO2 max) using Karvonen´s formula, performed on a cycloergometer. Were used Borg scale (12-13) and Polar® heart monitors to control heart rate.
Other Names:
Microcurrent device in the abdominal region with four transcutaneous electrodes in a parallel position, intensity below the sensivity threshold and a maximum of 1 mA.
Other Names:
microcurrent device in the abdominal whith intensity below the sensivity threshold and a maximum of 1 mA.
Every 15 minutes changed from 25Hz to 50 Hz.
|
Experimental: percutaneous microcurrent
Experimental group 3 performed aerobic exercise just after microcurrent in the abdominal region with four percutaneous electrodes in a parallel position, intensity below the sensivity threshold and a maximum of 1 mA.
Every 15 minutes changed from 25Hz to 10 Hz.
|
Aerobic exercise just after microcurrent in the abdominal region, intensity below the sensivity threshold and a maximum of 1 mA. 30 minutes of aerobic moderate-intensity exercise (50%VO2 max) using Karvonen´s formula, performed on a cycloergometer. Were used Borg scale (12-13) and Polar® heart monitors to control heart rate.
Other Names:
microcurrent device in the abdominal whith intensity below the sensivity threshold and a maximum of 1 mA.
Every 15 minutes changed from 25Hz to 10 Hz.
Other Names:
Microcurrent device in the abdominal region with four percutaneous electrodes in a parallel position, intensity below the sensivity threshold and a maximum of 1 mA.
|
Experimental: Exercise at same time
Experimental group 4 performed aerobic exercise at the same time microcurrent in the abdominal region with four transcutaneous electrodes in a parallel position, intensity below the sensivity threshold and a maximum of 1 mA.
Every 15 minutes changed from 25Hz to 10 Hz.
|
Microcurrent device in the abdominal region with four transcutaneous electrodes in a parallel position, intensity below the sensivity threshold and a maximum of 1 mA.
Other Names:
microcurrent device in the abdominal whith intensity below the sensivity threshold and a maximum of 1 mA.
Every 15 minutes changed from 25Hz to 10 Hz.
Other Names:
Aerobic exercise at the same time microcurrent in the abdominal region, intensity below the sensivity threshold and a maximum of 1 mA. 30 minutes of aerobic moderate-intensity exercise (50%VO2 max) using Karvonen´s formula, performed on a cycloergometer. Were used Borg scale (12-13) and Polar® heart monitors to control heart rate.
Other Names:
|
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.
|
Aerobic exercise just after microcurrent in the abdominal region, intensity below the sensivity threshold and a maximum of 1 mA. 30 minutes of aerobic moderate-intensity exercise (50%VO2 max) using Karvonen´s formula, performed on a cycloergometer. Were used Borg scale (12-13) and Polar® heart monitors to control heart rate.
Other Names:
Microcurrent device in the abdominal region with four transcutaneous electrodes in a parallel position, intensity below the sensivity threshold and a maximum of 1 mA.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
subcutaneous abdominal fat and viceral abdominal fat
Time Frame: five weeks after the intervencion
|
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
|
five weeks after the intervencion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
bioimpedance values
Time Frame: five weeks after the intervencion
|
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.
|
five weeks after the intervencion
|
cholesterol, triglycerides and glucose levels
Time Frame: five weeks after intervention
|
The volunteers were on fasting (12 hours) and was collected a blood sample on finger to measure cholesterol, triglycerides and glucose levels.
The results were recorded through the classes
|
five weeks after intervention
|
perimeters measurements
Time Frame: five weeks after intervencion
|
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
|
five weeks after intervencion
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Suprailiac, vertical and horizontal abdominal skinfolds
Time Frame: five weeks after intervencion
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Suprailiac, vertical and horizontal abdominal skinfolds were performed three times in right hemi body, by caliper
|
five weeks after intervencion
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
International Physical Activity Questionnaire
Time Frame: five weeks after the intervencion
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moderate physical activity level were used to monitor lifestyle during sessions
|
five weeks after the intervencion
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Food Frequency Questionnaire
Time Frame: five weeks after intervencion
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Food Frequency Questionnaire were used to monitor lifestyle during sessions.
|
five weeks after intervencion
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.
- Donnelly JE, Blair SN, Jakicic JM, Manore MM, Rankin JW, Smith BK; American College of Sports Medicine. American College of Sports Medicine Position Stand. Appropriate physical activity intervention strategies for weight loss and prevention of weight regain for adults. Med Sci Sports Exerc. 2009 Feb;41(2):459-71. doi: 10.1249/MSS.0b013e3181949333. Erratum In: Med Sci Sports Exerc. 2009 Jul;41(7):1532.
- Ribeiro-Filho FF, Faria AN, Azjen S, Zanella MT, Ferreira SR. Methods of estimation of visceral fat: advantages of ultrasonography. Obes Res. 2003 Dec;11(12):1488-94. doi: 10.1038/oby.2003.199.
- Hamida ZH, Comtois AS, Portmann M, Boucher JP, Savard R. Effect of electrical stimulation on lipolysis of human white adipocytes. Appl Physiol Nutr Metab. 2011 Apr;36(2):271-5. doi: 10.1139/h11-011.
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-001
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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