Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-03-06 @ 5:58 PM
Study NCT ID:
NCT02970812
Status:
COMPLETED
Last Update Posted:
2021-06-10
First Post:
2016-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Electrical Muscle Stimulation on Waist Circumference in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056128', 'term': 'Obesity, Abdominal'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'saylee@pnu.edu', 'phone': '3601442', 'title': 'Sang Yeoup Lee', 'phoneExt': '55', 'organization': 'Family Medicine Clinic, Pusan National University Yangsan Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'description': 'not-occurred', 'eventGroups': [{'id': 'EG000', 'title': 'Electrical Muscle Stimulation', 'description': "EMS program was consisted of warm-up, warm-down, contraction and relaxation. It was programed to be resemble to actual muscle action of voluntary exercise. To increase energy consumption as high intensity exercise, tripled the contraction duration. EMS group used Program 3 and regulated intensity though channel from 1 to 4.\n\nEMS: Participants were under EMS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back.", 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Electrical Nerve Stimulation', 'description': "Transcutaneous group used Transcutaneous Electrical Nerve Stimulation (TENS) which is the use of electric current produced to stimulate the sensory nerves to block pain signal. It is programed to applied currents regularly, once a second with a frequency of 1 Hz.\n\nTENS: Participants were under TENS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back.", 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrical Muscle Stimulation', 'description': "EMS program was consisted of warm-up, warm-down, contraction and relaxation. It was programed to be resemble to actual muscle action of voluntary exercise. To increase energy consumption as high intensity exercise, tripled the contraction duration. EMS group used Program 3 and regulated intensity though channel from 1 to 4.\n\nEMS: Participants were under EMS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back."}, {'id': 'OG001', 'title': 'Electrical Nerve Stimulation', 'description': "Transcutaneous group used Transcutaneous Electrical Nerve Stimulation (TENS) which is the use of electric current produced to stimulate the sensory nerves to block pain signal. It is programed to applied currents regularly, once a second with a frequency of 1 Hz.\n\nTENS: Participants were under TENS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back."}], 'classes': [{'categories': [{'measurements': [{'value': '87.0', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '89.4', 'spread': '9.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Waist circumference was measured by a tape', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Electrical Muscle Stimulation', 'description': "EMS program was consisted of warm-up, warm-down, contraction and relaxation. It was programed to be resemble to actual muscle action of voluntary exercise. To increase energy consumption as high intensity exercise, tripled the contraction duration. EMS group used Program 3 and regulated intensity though channel from 1 to 4.\n\nEMS: Participants were under EMS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back."}, {'id': 'FG001', 'title': 'Electrical Nerve Stimulation', 'description': "Transcutaneous group used Transcutaneous Electrical Nerve Stimulation (TENS) which is the use of electric current produced to stimulate the sensory nerves to block pain signal. It is programed to applied currents regularly, once a second with a frequency of 1 Hz.\n\nTENS: Participants were under TENS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Electrical Muscle Stimulation', 'description': "EMS program was consisted of warm-up, warm-down, contraction and relaxation. It was programed to be resemble to actual muscle action of voluntary exercise. To increase energy consumption as high intensity exercise, tripled the contraction duration. EMS group used Program 3 and regulated intensity though channel from 1 to 4.\n\nEMS: Participants were under EMS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back."}, {'id': 'BG001', 'title': 'Electrical Nerve Stimulation', 'description': "Transcutaneous group used Transcutaneous Electrical Nerve Stimulation (TENS) which is the use of electric current produced to stimulate the sensory nerves to block pain signal. It is programed to applied currents regularly, once a second with a frequency of 1 Hz.\n\nTENS: Participants were under TENS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'spread': '12.9', 'groupId': 'BG000'}, {'value': '38.5', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '39', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Waist circumference', 'classes': [{'categories': [{'measurements': [{'value': '92.2', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '92.3', 'spread': '7.2', 'groupId': 'BG001'}, {'value': '92.2', 'spread': '9.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CT visceral fat', 'classes': [{'categories': [{'measurements': [{'value': '105.7', 'spread': '66.3', 'groupId': 'BG000'}, {'value': '91.0', 'spread': '48.3', 'groupId': 'BG001'}, {'value': '95.2', 'spread': '58.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-28', 'studyFirstSubmitDate': '2016-11-15', 'resultsFirstSubmitDate': '2018-10-10', 'studyFirstSubmitQcDate': '2016-11-18', 'lastUpdatePostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-06', 'studyFirstPostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Waist Circumference', 'timeFrame': '12 weeks', 'description': 'Waist circumference was measured by a tape'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Abdominal Obesity']}, 'descriptionModule': {'briefSummary': 'This randomized, placebo-controlled, double-blind, controlled study was designed to investigate the efficacy of electrical muscle simulation (EMS) for treatment of waist circumference (WC) reduction in abdominal obese adults.\n\n60 patients with abdominal obese, man with WC \\> 90 cm and woman with WC \\> 80 cm, received EMS as experimental group (EG) or transcutaneous electrical nerve stimulation (TENS) as control group (CG) 5 times a week for 12 weeks.', 'detailedDescription': 'Background: This randomized, placebo-controlled, double-blind, controlled study was designed to investigate the efficacy of electrical muscle simulation (EMS) for treatment of waist circumference (WC) reduction in abdominal obese adults.\n\nMethods: 60 patients with abdominal obese, man with WC \\> 90 cm and woman with WC \\> 80 cm, received EMS as experimental group (EG) or transcutaneous electrical nerve stimulation (TENS) as control group (CG) 5 times a week for 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has abdominal obese seventy subjects between the age 18 and 65 years\n* Abdominal obesity was defined as having a waist circumference (WC) \\>90 cm for men or WC \\>80 cm for women was defined based on the Asia-Pacific criteria of the International Diabetes Federation.\n\nExclusion Criteria:\n\n* pregnant or breastfeeding, had taken any treatment for weight loss or any medication known to affect weight\n* had a weight loss of 3% or more in the preceding 3 months, had undergone any major surgery during the 1 year prior to study commencement\n* had any inserted metallic materials including a pacemaker.\n* aspartate aminotransferase or alanine aminotransferase of 100 mg/dL or more\n* serum creatinine of 1.5 mg/dL or more\n* a history of coronary arterial disease or cerebrovascular disease, impairment of a major organ system, cancer, severe lung diseases, severe cerebral trauma, uncontrolled hypertension and psychiatric diseases including eating disorder, etc.'}, 'identificationModule': {'nctId': 'NCT02970812', 'briefTitle': 'Effects of Electrical Muscle Stimulation on Waist Circumference in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Pusan National University Yangsan Hospital'}, 'officialTitle': 'Effects of Electrical Muscle Stimulation on Waist Circumference in Adults: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2003011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electrical Muscle Stimulation', 'description': 'Electrical Muscle Stimulation (EMS) program was consisted of warm-up, warm-down, contraction and relaxation. It was programed to be resemble to actual muscle action of voluntary exercise. To increase energy consumption as high intensity exercise, tripled the contraction duration. EMS group used Program 3 and regulated intensity though channel from 1 to 4.', 'interventionNames': ['Device: Electrical Muscle Stimulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Transcutaneous Electrical Nerve Stimulation', 'description': 'Transcutaneous group used Transcutaneous Electrical Nerve Stimulation (TENS) which is the use of electric current produced to stimulate the sensory nerves to block pain signal. It is programed to applied currents regularly, once a second with a frequency of 1 Hz.', 'interventionNames': ['Device: Transcutaneous Electrical Nerve Stimulation']}], 'interventions': [{'name': 'Electrical Muscle Stimulation', 'type': 'DEVICE', 'description': "Participants were under EMS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back.", 'armGroupLabels': ['Electrical Muscle Stimulation']}, {'name': 'Transcutaneous Electrical Nerve Stimulation', 'type': 'DEVICE', 'description': "Participants were under TENS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back.", 'armGroupLabels': ['Transcutaneous Electrical Nerve Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50612', 'city': 'Yangsan', 'state': 'Gyeungsangnam-do', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'overallOfficials': [{'name': 'Sang Yeoup Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pusan National University Yangsan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pusan National University Yangsan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sang Yeoup Lee', 'investigatorAffiliation': 'Pusan National University Yangsan Hospital'}}}}