NCT01853761

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
Last Updated

May 15, 2013

Status Verified

May 1, 2013

Enrollment Period

2 months

First QC Date

April 18, 2013

Last Update Submit

May 9, 2013

Conditions

Obesity, Abdominal

Keywords

abdominal fatmetabolic syndromemicrocurrentaerobic exercise

Outcome Measures

Primary Outcomes (1)

  • 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

    five weeks after the intervencion

Secondary Outcomes (4)

  • bioimpedance values

    five weeks after the intervencion

  • cholesterol, triglycerides and glucose levels

    five weeks after intervention

  • perimeters measurements

    five weeks after intervencion

  • Suprailiac, vertical and horizontal abdominal skinfolds

    five weeks after intervencion

Other Outcomes (2)

  • International Physical Activity Questionnaire

    five weeks after the intervencion

  • Food Frequency Questionnaire

    five weeks after intervencion

Study Arms (5)

Exercise after, Transcutaneos, 25-10Hz

EXPERIMENTAL

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 afterDevice: TranscutaneosDevice: 25-10Hz

25-50Hz microcurrent

EXPERIMENTAL

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 afterDevice: TranscutaneosDevice: 25-50Hz microcurrent

percutaneous microcurrent

EXPERIMENTAL

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 afterDevice: percutaneous microcurrentDevice: 25-10Hz

Exercise at same time

EXPERIMENTAL

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 timeDevice: TranscutaneosDevice: 25-10Hz

Control Group

PLACEBO COMPARATOR

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 afterDevice: Transcutaneos

Interventions

Exercise afterDEVICE

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.

Also known as: Aerobic exercise after microcurrent
25-50Hz microcurrentControl GroupExercise after, Transcutaneos, 25-10Hzpercutaneous microcurrent
Exercise at same timeDEVICE

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.

Also known as: Aerobic exercise at same time microcurrent
Exercise at same time
TranscutaneosDEVICE

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.

Also known as: transcutaneos microcurrent
25-50Hz microcurrentControl GroupExercise after, Transcutaneos, 25-10HzExercise at same time
percutaneous microcurrentDEVICE

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.

percutaneous microcurrent
25-10HzDEVICE

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.

Also known as: 25-10Hz microcurrent
Exercise after, Transcutaneos, 25-10HzExercise at same timepercutaneous microcurrent
25-50Hz microcurrentDEVICE

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.

25-50Hz microcurrent

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Andreia Noites

Vila Nova de Gaia, Porto District, 4400-303, Portugal

Location

Andreia Noites

Vila Nova de Gaia, Porto District, 4400-330, Portugal

Location

Related Publications (4)

  • Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.

    PMID: 17167477BACKGROUND

  • 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.

    PMID: 19127177BACKGROUND

  • 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.

    PMID: 14694213BACKGROUND

  • 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.

    PMID: 21609289BACKGROUND

MeSH Terms

Conditions

Obesity, AbdominalMetabolic Syndrome

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Andreia Noites, MSc

    Escola Superior de Tecnologia da Saúde do Porto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 18, 2013

First Posted

May 15, 2013

Study Start

July 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

May 15, 2013

Record last verified: 2013-05

Locations

PT(2)