Microcurrent and Aerobic Exercise Effects in Abdominal Fat
Primary Purpose
Obesity, Abdominal
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Transcutaneous microcurrent
Aerobic exercise
Sponsored by
About this trial
This is an interventional prevention trial for Obesity, Abdominal focused on measuring Abdominal fat, Metabolic syndrome, Microcurrent, Aerobic exercise, Lipolysis
Eligibility Criteria
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.
Sites / Locations
- Andreia Noites
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Transcutaneous microcurrent
Control group
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Change in catecholamines and glycerol concentrations
Blood analysis collection was carried out with help from an clinical analysis technician. The volunteers were not fasting.
Change in proportion of energy source
K4b2 (COSMED ®) was used for analysis of cardiopulmonary gas exchange in real time.
Change in electromyographic activity
Recording the surface electrical activity produced by rectus abdominis and external oblique in front bridge and side bridge exercise, respectively.
Secondary Outcome Measures
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).
Suprailiac, vertical and horizontal abdominal skinfolds
Suprailiac, vertical and horizontal abdominal skinfolds were performed two times in right hemi body, by caliper.
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.
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.
Full Information
NCT ID
NCT02110927
First Posted
March 21, 2014
Last Updated
October 23, 2014
Sponsor
Escola Superior de Tecnologia da Saúde do Porto
1. Study Identification
Unique Protocol Identification Number
NCT02110927
Brief Title
Microcurrent and Aerobic Exercise Effects in Abdominal Fat
Official Title
Microcurrent and Aerobic Exercise Effects in Glycerol, Catecholamines, Energetic Source and Muscle Activity
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Escola Superior de Tecnologia da Saúde do Porto
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study was to analyze microcurrent short term effects used with aerobic exercise on abdominal fat.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Abdominal
Keywords
Abdominal fat, Metabolic syndrome, Microcurrent, Aerobic exercise, Lipolysis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcutaneous microcurrent
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcutaneous microcurrent
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Aerobic exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in catecholamines and glycerol concentrations
Description
Blood analysis collection was carried out with help from an clinical analysis technician. The volunteers were not fasting.
Time Frame
10 minutes before the interventions, after interventions (duration of interventions - 90 minutes) and after 24 hours
Title
Change in proportion of energy source
Description
K4b2 (COSMED ®) was used for analysis of cardiopulmonary gas exchange in real time.
Time Frame
Immediately before (for 3 minutes) and during exercise (duration of exercise - 50 minutes)
Title
Change in electromyographic activity
Description
Recording the surface electrical activity produced by rectus abdominis and external oblique in front bridge and side bridge exercise, respectively.
Time Frame
5 minutes before and after microcurrent
Secondary Outcome Measure Information:
Title
Subcutaneous abdominal fat and visceral abdominal fat
Description
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).
Time Frame
20 minutes before the interventions
Title
Suprailiac, vertical and horizontal abdominal skinfolds
Description
Suprailiac, vertical and horizontal abdominal skinfolds were performed two times in right hemi body, by caliper.
Time Frame
20 minutes before the interventions
Title
Perimeters measurements
Description
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.
Time Frame
20 minutes before the interventions
Title
Change in cholesterol, triglycerides and glucose concentrations
Description
Blood analysis collection was carried out with help from an clinical analysis technician. The volunteers were not fasting.
Time Frame
10 minutes before the interventions, after interventions (duration of interventions - 90 minutes)
Other Pre-specified Outcome Measures:
Title
International Physical Activity Questionnaire
Description
Used to evaluate the level of physical activity of the volunteers
Time Frame
30 minutes before the interventions
Title
Food Frequency Questionnaire
Description
Used to evaluate the lifestyle of the volunteers
Time Frame
30 minutes before the interventions
Title
Bioimpedance values
Description
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
Time Frame
30 minutes before the interventions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreia Noites, MSc
Organizational Affiliation
Escola Superior de Tecnologia da Saúde do Porto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rui Vilarinho, BSc
Organizational Affiliation
Escola Superior de Tecnologia da Saúde do Porto
Official's Role
Study Chair
Facility Information:
Facility Name
Andreia Noites
City
Vila Nova de Gaia
State/Province
Porto
ZIP/Postal Code
4400-303
Country
Portugal
12. IPD Sharing Statement
Citations:
PubMed Identifier
20025992
Citation
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.
Results Reference
background
PubMed Identifier
17167477
Citation
Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.
Results Reference
background
PubMed Identifier
16836692
Citation
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.
Results Reference
background
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Microcurrent and Aerobic Exercise Effects in Abdominal Fat
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