Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2026-02-01 @ 6:56 AM
Study NCT ID:
NCT01853761
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2013-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microcurrent and Aerobic Exercise Effects on Abdominal Fat
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056128', 'term': 'Obesity, Abdominal'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-09', 'studyFirstSubmitDate': '2013-04-18', 'studyFirstSubmitQcDate': '2013-05-09', 'lastUpdatePostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'International Physical Activity Questionnaire', 'timeFrame': 'five weeks after the intervencion', 'description': 'moderate physical activity level were used to monitor lifestyle during sessions'}, {'measure': 'Food Frequency Questionnaire', 'timeFrame': 'five weeks after intervencion', 'description': 'Food Frequency Questionnaire were used to monitor lifestyle during sessions.'}], 'primaryOutcomes': [{'measure': 'subcutaneous abdominal fat and viceral abdominal fat', 'timeFrame': 'five weeks after the intervencion', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'bioimpedance values', 'timeFrame': 'five weeks after the intervencion', 'description': '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.'}, {'measure': 'cholesterol, triglycerides and glucose levels', 'timeFrame': 'five weeks after intervention', 'description': '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'}, {'measure': 'perimeters measurements', 'timeFrame': 'five weeks after intervencion', 'description': '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'}, {'measure': 'Suprailiac, vertical and horizontal abdominal skinfolds', 'timeFrame': 'five weeks after intervencion', 'description': 'Suprailiac, vertical and horizontal abdominal skinfolds were performed three times in right hemi body, by caliper'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['abdominal fat', 'metabolic syndrome', 'microcurrent', 'aerobic exercise'], 'conditions': ['Obesity, Abdominal']}, 'referencesModule': {'references': [{'pmid': '17167477', 'type': 'BACKGROUND', 'citation': 'Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.'}, {'pmid': '19127177', 'type': 'BACKGROUND', 'citation': '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': '14694213', 'type': 'BACKGROUND', 'citation': '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': '21609289', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to analyze microcurrent short and long term effects used with aerobic exercise on abdominal fat.', 'detailedDescription': "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.\n\nNevertheless 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 .\n\nAbdominal fat excess is associated with cardiometabolic diseases and can be prevented using microcurrent and aerobic exercise to stimulate lipolysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 30 years\n* presenting a normal to pre-obese body mass index (18.5 - 29.9 Kg/m2)\n* moderate physical activity level (between 600 and 3000 metabolic-minute/week (MET-min/week)) scored by International Physical Activity Questionnaire (IPAQ)\n\nExclusion Criteria:\n\n* submitted to other fat reduce procedure\n* to show cardiovascular risk factors or diseases and/or any physical condition limiting aerobic exercise\n* to present any contra indications to microcurrent and/or aerobic exercise\n* to take medication that influence lipid metabolism, and to be pregnant'}, 'identificationModule': {'nctId': 'NCT01853761', 'briefTitle': 'Microcurrent and Aerobic Exercise Effects on Abdominal Fat', 'organization': {'class': 'OTHER', 'fullName': 'Escola Superior de Tecnologia da Saúde do Porto'}, 'officialTitle': 'Microcurrent and Aerobic Exercise Effects on Abdominal Fat', 'orgStudyIdInfo': {'id': 'AN-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise after, Transcutaneos, 25-10Hz', 'description': '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.', 'interventionNames': ['Device: Exercise after', 'Device: Transcutaneos', 'Device: 25-10Hz']}, {'type': 'EXPERIMENTAL', 'label': '25-50Hz microcurrent', 'description': '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.', 'interventionNames': ['Device: Exercise after', 'Device: Transcutaneos', 'Device: 25-50Hz microcurrent']}, {'type': 'EXPERIMENTAL', 'label': 'percutaneous microcurrent', 'description': '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.', 'interventionNames': ['Device: Exercise after', 'Device: percutaneous microcurrent', 'Device: 25-10Hz']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise at same time', 'description': '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.', 'interventionNames': ['Device: Exercise at same time', 'Device: Transcutaneos', 'Device: 25-10Hz']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': '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.', 'interventionNames': ['Device: Exercise after', 'Device: Transcutaneos']}], 'interventions': [{'name': 'Exercise after', 'type': 'DEVICE', 'otherNames': ['Aerobic exercise after microcurrent'], 'description': 'Aerobic exercise just after microcurrent in the abdominal region, intensity below the sensivity threshold and a maximum of 1 mA.\n\n30 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.', 'armGroupLabels': ['25-50Hz microcurrent', 'Control Group', 'Exercise after, Transcutaneos, 25-10Hz', 'percutaneous microcurrent']}, {'name': 'Exercise at same time', 'type': 'DEVICE', 'otherNames': ['Aerobic exercise at same time microcurrent'], 'description': 'Aerobic exercise at the same time microcurrent in the abdominal region, intensity below the sensivity threshold and a maximum of 1 mA.\n\n30 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.', 'armGroupLabels': ['Exercise at same time']}, {'name': 'Transcutaneos', 'type': 'DEVICE', 'otherNames': ['transcutaneos microcurrent'], 'description': '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.', 'armGroupLabels': ['25-50Hz microcurrent', 'Control Group', 'Exercise after, Transcutaneos, 25-10Hz', 'Exercise at same time']}, {'name': 'percutaneous microcurrent', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['percutaneous microcurrent']}, {'name': '25-10Hz', 'type': 'DEVICE', 'otherNames': ['25-10Hz microcurrent'], 'description': '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.', 'armGroupLabels': ['Exercise after, Transcutaneos, 25-10Hz', 'Exercise at same time', 'percutaneous microcurrent']}, {'name': '25-50Hz microcurrent', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['25-50Hz microcurrent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4400-303', 'city': 'Vila Nova de Gaia', 'state': 'Porto District', 'country': 'Portugal', 'facility': 'Andreia Noites', 'geoPoint': {'lat': 41.12401, 'lon': -8.61241}}, {'zip': '4400-330', 'city': 'Vila Nova de Gaia', 'state': 'Porto District', 'country': 'Portugal', 'facility': 'Andreia Noites', 'geoPoint': {'lat': 41.12401, 'lon': -8.61241}}], 'overallOfficials': [{'name': 'Andreia Noites, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Escola Superior de Tecnologia da Saúde do Porto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Escola Superior de Tecnologia da Saúde do Porto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Andreia Noites', 'investigatorAffiliation': 'Escola Superior de Tecnologia da Saúde do Porto'}}}}