NCT02110927

Brief Summary

The purpose of this study was to analyze microcurrent short 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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

8 months

First QC Date

March 21, 2014

Last Update Submit

October 23, 2014

Conditions

Keywords

Abdominal fatMetabolic syndromeMicrocurrentAerobic exerciseLipolysis

Outcome Measures

Primary Outcomes (3)

  • Change in catecholamines and glycerol concentrations

    Blood analysis collection was carried out with help from an clinical analysis technician. The volunteers were not fasting.

    10 minutes before the interventions, after interventions (duration of interventions - 90 minutes) and after 24 hours

  • Change in proportion of energy source

    K4b2 (COSMED ®) was used for analysis of cardiopulmonary gas exchange in real time.

    Immediately before (for 3 minutes) and during exercise (duration of exercise - 50 minutes)

  • Change in electromyographic activity

    Recording the surface electrical activity produced by rectus abdominis and external oblique in front bridge and side bridge exercise, respectively.

    5 minutes before and after microcurrent

Secondary Outcomes (4)

  • Subcutaneous abdominal fat and visceral abdominal fat

    20 minutes before the interventions

  • Suprailiac, vertical and horizontal abdominal skinfolds

    20 minutes before the interventions

  • Perimeters measurements

    20 minutes before the interventions

  • Change in cholesterol, triglycerides and glucose concentrations

    10 minutes before the interventions, after interventions (duration of interventions - 90 minutes)

Other Outcomes (3)

  • International Physical Activity Questionnaire

    30 minutes before the interventions

  • Food Frequency Questionnaire

    30 minutes before the interventions

  • Bioimpedance values

    30 minutes before the interventions

Study Arms (2)

Transcutaneous microcurrent

EXPERIMENTAL

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

Device: Transcutaneous microcurrentDevice: Aerobic exercise

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: Aerobic exercise

Interventions

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.

Transcutaneous microcurrent

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.

Control groupTranscutaneous microcurrent

Eligibility Criteria

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

You may qualify if:

  • age between 18 and 30 years.

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 contraindications 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 (1)

Andreia Noites

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

Location

Related Publications (3)

  • 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.

    PMID: 20025992BACKGROUND
  • Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.

    PMID: 17167477BACKGROUND
  • 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.

    PMID: 16836692BACKGROUND

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
  • Rui Vilarinho, BSc

    Escola Superior de Tecnologia da Saúde do Porto

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

March 21, 2014

First Posted

April 10, 2014

Study Start

February 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 24, 2014

Record last verified: 2014-10

Locations