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Trial record 1 of 7 for:    19127177 [PUBMED-IDS]
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Microcurrent and Aerobic Exercise Effects on Abdominal Fat

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ClinicalTrials.gov Identifier: NCT01853761
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : May 15, 2013
Sponsor:
Information provided by (Responsible Party):
Andreia Noites, Escola Superior de Tecnologia da Saúde do Porto

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

Condition or disease Intervention/treatment Phase
Obesity, Abdominal Device: Exercise after Device: Exercise at same time Device: Transcutaneos Device: percutaneous microcurrent Device: 25-10Hz Device: 25-50Hz microcurrent Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Microcurrent and Aerobic Exercise Effects on Abdominal Fat
Study Start Date : July 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


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.
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.

Other Name: Aerobic exercise after microcurrent

Device: 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.
Other Name: transcutaneos microcurrent

Device: 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.
Other Name: 25-10Hz microcurrent

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.
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.

Other Name: Aerobic exercise after microcurrent

Device: 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.
Other Name: transcutaneos microcurrent

Device: 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.

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.
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.

Other Name: Aerobic exercise after microcurrent

Device: 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.

Device: 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.
Other Name: 25-10Hz microcurrent

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.
Device: 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.

Other Name: Aerobic exercise at same time microcurrent

Device: 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.
Other Name: transcutaneos microcurrent

Device: 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.
Other Name: 25-10Hz microcurrent

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.
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.

Other Name: Aerobic exercise after microcurrent

Device: 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.
Other Name: transcutaneos microcurrent




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. Suprailiac, vertical and horizontal abdominal skinfolds [ Time Frame: five weeks after intervencion ]
    Suprailiac, vertical and horizontal abdominal skinfolds were performed three times in right hemi body, by caliper


Other Outcome Measures:
  1. International Physical Activity Questionnaire [ Time Frame: five weeks after the intervencion ]
    moderate physical activity level were used to monitor lifestyle during sessions

  2. Food Frequency Questionnaire [ Time Frame: five weeks after intervencion ]
    Food Frequency Questionnaire were used to monitor lifestyle during sessions.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853761


Locations
Portugal
Andreia Noites
Vila Nova de Gaia, Porto, Portugal, 4400-303
Andreia Noites
Vila Nova de Gaia, Porto, Portugal, 4400-330
Sponsors and Collaborators
Escola Superior de Tecnologia da Saúde do Porto
Investigators
Principal Investigator: Andreia Noites, MSc Escola Superior de Tecnologia da Saúde do Porto