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Microcurrent and Aerobic Exercise Effects on Abdominal Fat

Primary Purpose

Obesity, Abdominal

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Exercise after
Exercise at same time
Transcutaneos
percutaneous microcurrent
25-10Hz
25-50Hz microcurrent
Sponsored by
Escola Superior de Tecnologia da Saúde do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Abdominal focused on measuring abdominal fat, metabolic syndrome, microcurrent, aerobic exercise

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Andreia Noites
  • Andreia Noites

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Exercise after, Transcutaneos, 25-10Hz

25-50Hz microcurrent

percutaneous microcurrent

Exercise at same time

Control Group

Arm Description

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.

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.

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.

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.

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

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

Secondary Outcome Measures

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.
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
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
Suprailiac, vertical and horizontal abdominal skinfolds
Suprailiac, vertical and horizontal abdominal skinfolds were performed three times in right hemi body, by caliper

Full Information

First Posted
April 18, 2013
Last Updated
May 9, 2013
Sponsor
Escola Superior de Tecnologia da Saúde do Porto
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1. Study Identification

Unique Protocol Identification Number
NCT01853761
Brief Title
Microcurrent and Aerobic Exercise Effects on Abdominal Fat
Official Title
Microcurrent and Aerobic Exercise Effects on Abdominal Fat
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (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 and long term effects used with aerobic exercise on abdominal fat.
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.

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise after, Transcutaneos, 25-10Hz
Arm Type
Experimental
Arm Description
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.
Arm Title
25-50Hz microcurrent
Arm Type
Experimental
Arm Description
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.
Arm Title
percutaneous microcurrent
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise at same time
Arm Type
Experimental
Arm Description
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.
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)
Exercise after
Other Intervention Name(s)
Aerobic exercise after microcurrent
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Exercise at same time
Other Intervention Name(s)
Aerobic exercise at same time microcurrent
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcutaneos
Other Intervention Name(s)
transcutaneos microcurrent
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
percutaneous microcurrent
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
25-10Hz
Other Intervention Name(s)
25-10Hz microcurrent
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
25-50Hz microcurrent
Intervention Description
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.
Primary Outcome Measure Information:
Title
subcutaneous abdominal fat and viceral 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
Time Frame
five weeks after the intervencion
Secondary Outcome Measure Information:
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
five weeks after the intervencion
Title
cholesterol, triglycerides and glucose levels
Description
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
Time Frame
five weeks after intervention
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
five weeks after intervencion
Title
Suprailiac, vertical and horizontal abdominal skinfolds
Description
Suprailiac, vertical and horizontal abdominal skinfolds were performed three times in right hemi body, by caliper
Time Frame
five weeks after intervencion
Other Pre-specified Outcome Measures:
Title
International Physical Activity Questionnaire
Description
moderate physical activity level were used to monitor lifestyle during sessions
Time Frame
five weeks after the intervencion
Title
Food Frequency Questionnaire
Description
Food Frequency Questionnaire were used to monitor lifestyle during sessions.
Time Frame
five weeks after intervencion

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 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
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
Facility Information:
Facility Name
Andreia Noites
City
Vila Nova de Gaia
State/Province
Porto
ZIP/Postal Code
4400-303
Country
Portugal
Facility Name
Andreia Noites
City
Vila Nova de Gaia
State/Province
Porto
ZIP/Postal Code
4400-330
Country
Portugal

12. IPD Sharing Statement

Citations:
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
19127177
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.
Results Reference
background
PubMed Identifier
14694213
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. doi: 10.1038/oby.2003.199.
Results Reference
background
PubMed Identifier
21609289
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.
Results Reference
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Microcurrent and Aerobic Exercise Effects on Abdominal Fat

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