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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

Tracking Information
First Submitted Date  ICMJE April 18, 2013
First Posted Date  ICMJE May 15, 2013
Last Update Posted Date May 15, 2013
Study Start Date  ICMJE July 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2013)
  • 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.
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 9, 2013)
  • International Physical Activity Questionnaire [ Time Frame: five weeks after the intervencion ]
    moderate physical activity level were used to monitor lifestyle during sessions
  • Food Frequency Questionnaire [ Time Frame: five weeks after intervencion ]
    Food Frequency Questionnaire were used to monitor lifestyle during sessions.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Microcurrent and Aerobic Exercise Effects on Abdominal Fat
Official Title  ICMJE Microcurrent and Aerobic Exercise Effects on Abdominal Fat
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Obesity, Abdominal
Intervention  ICMJE
  • 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: 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: 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
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Exercise after
    • Device: Transcutaneos
    • Device: 25-10Hz
  • 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.
    Interventions:
    • Device: Exercise after
    • Device: Transcutaneos
    • Device: 25-50Hz microcurrent
  • 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.
    Interventions:
    • Device: Exercise after
    • Device: percutaneous microcurrent
    • Device: 25-10Hz
  • 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.
    Interventions:
    • Device: Exercise at same time
    • Device: Transcutaneos
    • Device: 25-10Hz
  • 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.
    Interventions:
    • Device: Exercise after
    • Device: Transcutaneos
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2013)
45
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Portugal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01853761
Other Study ID Numbers  ICMJE AN-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andreia Noites, Escola Superior de Tecnologia da Saúde do Porto
Study Sponsor  ICMJE Escola Superior de Tecnologia da Saúde do Porto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andreia Noites, MSc Escola Superior de Tecnologia da Saúde do Porto
PRS Account Escola Superior de Tecnologia da Saúde do Porto
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP