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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01853761
Other study ID # AN-001
Secondary ID
Status Completed
Phase N/A
First received April 18, 2013
Last updated May 9, 2013
Start date July 2011
Est. completion date September 2011

Study information

Verified date May 2013
Source Escola Superior de Tecnologia da Saúde do Porto
Contact n/a
Is FDA regulated No
Health authority Portugal: Ethics Committee for Clinical Research
Study type Interventional

Clinical Trial Summary

The purpose of this study was to analyze microcurrent short and long term effects used with aerobic exercise on abdominal fat.


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 30 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Device:
Exercise after
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.
Exercise at same time
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.
Transcutaneos
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.
percutaneous microcurrent
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.
25-10Hz
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.
25-50Hz microcurrent
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.

Locations

Country Name City State
Portugal Andreia Noites Vila Nova de Gaia Porto
Portugal Andreia Noites Vila Nova de Gaia Porto

Sponsors (1)

Lead Sponsor Collaborator
Escola Superior de Tecnologia da Saúde do Porto

Country where clinical trial is conducted

Portugal, 

References & Publications (4)

Després JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other International Physical Activity Questionnaire moderate physical activity level were used to monitor lifestyle during sessions five weeks after the intervencion Yes
Other Food Frequency Questionnaire Food Frequency Questionnaire were used to monitor lifestyle during sessions. five weeks after intervencion Yes
Primary subcutaneous abdominal fat and viceral abdominal fat 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 Yes
Secondary bioimpedance values 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 Yes
Secondary cholesterol, triglycerides and glucose levels 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 Yes
Secondary perimeters measurements 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 Yes
Secondary Suprailiac, vertical and horizontal abdominal skinfolds Suprailiac, vertical and horizontal abdominal skinfolds were performed three times in right hemi body, by caliper five weeks after intervencion Yes
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