Microcurrent and Aerobic Exercise Effects in Abdominal Fat

Obesity, Abdominal Clinical Trial

Official title:

Microcurrent and Aerobic Exercise Effects in Glycerol, Catecholamines, Energetic Source and Muscle Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02110927
• Other study ID #: AN-003
• Status: Completed
• Phase: N/A
• First received: March 21, 2014
• Last updated: October 23, 2014
• Start date: February 2014
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• 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 term effects used with aerobic exercise on abdominal fat.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Obesity, Abdominal

Intervention

Device:
• Transcutaneous microcurrent
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.
• Aerobic exercise
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.

Locations

Country	Name	City	State
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 (3)

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. Review. — View Citation

Bülow 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	International Physical Activity Questionnaire	Used to evaluate the level of physical activity of the volunteers	30 minutes before the interventions	Yes
Other	Food Frequency Questionnaire	Used to evaluate the lifestyle of the volunteers	30 minutes before the interventions	Yes
Other	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	30 minutes before the interventions	Yes
Primary	Change in catecholamines and glycerol concentrations	Blood analysis collection was carried out with help from an clinical analysis technician. The volunteers were not fasting.	10 minutes before the interventions, after interventions (duration of interventions - 90 minutes) and after 24 hours	Yes
Primary	Change in proportion of energy source	K4b2 (COSMED ®) was used for analysis of cardiopulmonary gas exchange in real time.	Immediately before (for 3 minutes) and during exercise (duration of exercise - 50 minutes)	Yes
Primary	Change in electromyographic activity	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	Yes
Secondary	Subcutaneous abdominal fat and visceral 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. Abdominal fat analyzed by dual-energy x-ray absorptiometry (DEXA).	20 minutes before the interventions	Yes
Secondary	Suprailiac, vertical and horizontal abdominal skinfolds	Suprailiac, vertical and horizontal abdominal skinfolds were performed two times in right hemi body, by caliper.	20 minutes before the interventions	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.	20 minutes before the interventions	Yes
Secondary	Change in cholesterol, triglycerides and glucose concentrations	Blood analysis collection was carried out with help from an clinical analysis technician. The volunteers were not fasting.	10 minutes before the interventions, after interventions (duration of interventions - 90 minutes)	Yes