Obesity, AbdominalNCT01853761
Microcurrent and Aerobic Exercise Effects on Abdominal Fat
A study testing Exercise after, Exercise at same time and Transcutaneos in people with Obesity, Abdominal, run by Escola Superior de Tecnologia da Saúde do Porto at 2 sites in Portugal.
Trial summary
The purpose of this study was to analyze microcurrent short and long term effects used with aerobic exercise on abdominal fat. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Abdominal
- What is being tested?
- Exercise after, Exercise at same time and Transcutaneos
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesPortugal
- Study dates
- Jul 2011to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites
Andreia Noites
Vila Nova de Gaia, Porto District, 4400-303
Andreia Noites
Vila Nova de Gaia, Porto District, 4400-330
About this study
The purpose of this study was to analyze microcurrent short and long term effects used with aerobic exercise on abdominal fat.
Read the 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.
- Conditions
- Obesity, Abdominal
- Being tested
- Exercise after, Exercise at same time, Transcutaneos, percutaneous microcurrent, 25-10Hz
- Keywords
- abdominal fat, metabolic syndrome, microcurrent, aerobic exercise
- Medical subject headings
- Obesity, Abdominal, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise afterDevice
Also called Aerobic exercise after microcurrent
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.
Exercise at same timeDevice
Also called Aerobic exercise at same time microcurrent
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.
TranscutaneosDevice
Also called transcutaneos microcurrent
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.
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.
25-10HzDevice
Also called 25-10Hz 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 10 Hz.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Exercise after; Device: Transcutaneos; Device: 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. Receives: Device: Exercise after; Device: Transcutaneos; Device: 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. Receives: Device: Exercise after; Device: percutaneous microcurrent; Device: 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. Receives: Device: Exercise at same time; Device: Transcutaneos; Device: 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. Receives: Device: Exercise after; Device: Transcutaneos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: five weeks after the intervencion
Secondary outcomes (4)
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.
Measured: five weeks after the intervencion
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
Measured: five weeks after intervention
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
Measured: five weeks after intervencion
Suprailiac, vertical and horizontal abdominal skinfolds
Suprailiac, vertical and horizontal abdominal skinfolds were performed three times in right hemi body, by caliper
Measured: five weeks after intervencion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startJul 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreia Noites, Escola Superior de Tecnologia da Saúde do Porto
- Investigators
- Andreia Noites, MSc, Principal investigator, Escola Superior de Tecnologia da Saúde do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853761
- Sponsor's protocol ID
- AN-001
- Status last verified
- May 2013
- First submitted
- 18 Apr 2013
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.
PubMed 17167477Donnelly 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.
PubMed 19127177Ribeiro-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.
PubMed 14694213Hamida 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.
PubMed 21609289
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcurrent and Aerobic Exercise Effects on Abdominal Fat
- ClinicalTrials.gov ID
- NCT01853761
- Acronym / sponsor ID
- AN-001
- Conditions
- Obesity, Abdominal
- Keywords
- abdominal fat, metabolic syndrome, microcurrent, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 15 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Exercise after, Transcutaneos, 25-10Hz | Experimental | Device: Exercise after, Device: Transcutaneos, Device: 25-10HzExperimental 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. |
| 25-50Hz microcurrent | Experimental | Device: Exercise after, Device: Transcutaneos, Device: 25-50Hz microcurrentExperimental 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. |
| percutaneous microcurrent | Experimental | Device: Exercise after, Device: percutaneous microcurrent, Device: 25-10HzExperimental 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. |
| Exercise at same time | Experimental | Device: Exercise at same time, Device: Transcutaneos, Device: 25-10HzExperimental 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 | Placebo comparator | Device: Exercise after, Device: TranscutaneosControl 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise afterAlso: Aerobic exercise after microcurrentAerobic 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. | Device | 25-50Hz microcurrent, Control Group, Exercise after, Transcutaneos, 25-10Hz, percutaneous microcurrent |
| Exercise at same timeAlso: Aerobic exercise at same time microcurrentAerobic 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. | Device | Exercise at same time |
| TranscutaneosAlso: transcutaneos microcurrentMicrocurrent device in the abdominal region with four transcutaneous electrodes in a parallel position, intensity below the sensivity threshold and a maximum of 1 mA. | Device | 25-50Hz microcurrent, Control Group, Exercise after, Transcutaneos, 25-10Hz, Exercise at same time |
| percutaneous microcurrentMicrocurrent 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 | percutaneous microcurrent |
| 25-10HzAlso: 25-10Hz microcurrentmicrocurrent 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. | Device | Exercise after, Transcutaneos, 25-10Hz, Exercise at same time, percutaneous microcurrent |
| 25-50Hz microcurrentmicrocurrent 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. | Device | 25-50Hz microcurrent |
Primary outcome
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
4 secondary outcomes
bioimpedance values
Time frame: five weeks after the intervencion
cholesterol, triglycerides and glucose levels
Time frame: five weeks after intervention
perimeters measurements
Time frame: five weeks after intervencion
Suprailiac, vertical and horizontal abdominal skinfolds
Time frame: five weeks after intervencion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
- Background: PubMed 17167477Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.
- Background: PubMed 19127177Donnelly 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.
- Background: PubMed 14694213Ribeiro-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.
- Background: PubMed 21609289Hamida 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreia Noites, MSc principal investigator
Escola Superior de Tecnologia da Saúde do Porto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise after, Exercise at same time and Transcutaneos in people with Obesity, Abdominal, run by Escola Superior de Tecnologia da Saúde do Porto at 2 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subcutaneous abdominal fat and viceral abdominal fat (time frame: five weeks after the intervencion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01853761, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2013.