Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-29 @ 10:00 AM
Study NCT ID:
NCT05117203
Status:
COMPLETED
Last Update Posted:
2022-10-14
First Post:
2021-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Electrostimulation on the Abdominal Muscles in Healthy Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-13', 'studyFirstSubmitDate': '2021-10-25', 'studyFirstSubmitQcDate': '2021-11-01', 'lastUpdatePostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of muscle thickness of the abdominal muscles by ultrasound through the technique "Rehabilitative Ultrasound Imaging" (RUSI).', 'timeFrame': 'One day', 'description': 'Measure muscle thickness before and after exercise with electrostimulation'}, {'measure': 'Measurement of the Distance between Rectus abdominis using ultrasound (RUSI)', 'timeFrame': 'One day', 'description': 'Measure the distance between Rectus abdominis before and after exercise with electrostimulation'}], 'secondaryOutcomes': [{'measure': 'International physical activity questionnaire (IPAQ)', 'timeFrame': 'One day', 'description': 'Classification according to low, moderate or high physical activity level'}, {'measure': 'Nijgemen questionnaire', 'timeFrame': 'One day', 'description': 'A level of respiratory distress equal to or higher than 23 points is an exclusion criterion for exclusion from the study'}, {'measure': 'Body height', 'timeFrame': 'One day', 'description': 'Body height in meters'}, {'measure': 'Body weight', 'timeFrame': 'One day', 'description': 'Body weight in kilograms'}, {'measure': 'Body mass index', 'timeFrame': 'One day', 'description': 'Calculation of body mass index in Kg/m2 according to Queletet method'}, {'measure': 'Heart frequency', 'timeFrame': 'One day', 'description': 'Measurement of the heart rate (beats per minute)'}, {'measure': 'Blood pressure', 'timeFrame': 'One day', 'description': 'Measurement of systolic and diastolic blood pressure using a sphygmomanometer'}, {'measure': 'body temperature', 'timeFrame': 'one day', 'description': 'Measurement of body temperature in Celsius with a digital thermometer'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Whole body electrostimulation', 'healthy', 'abdominal muscles', 'ultrasound', 'RUSI', 'WB-EMS'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To determine the immediate effects on the abdominal musculature, assessed by ultrasound (RUSI), due to the application of electrostimulation using whole body electrostimulation together with physical exercise in healthy people and to compare with the application of local EMS in the abdominal area and the same physical exercise session. The same intervention is carried out for the control group as the WB-EMS group but simulated.', 'detailedDescription': 'Evaluation of the immediate changes in the thickness of the abdominal muscles (Transversus abdominis, Internal and External Oblique and Rectus abdominis) and in the Interrectus distance after the physical exercise session together with whole body electrostimulation or local electrostimulation assessed by ultrasound (RUSI) in healthy people.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy participants\n* Good medical history without injury or chest pain in the past year\n* No surgeries in the previous year.\n\nExclusion Criteria:\n\n* Upper body mass index 30 Kg/m2\n* Level of professional or elite sports activity\n* Hyperventilation / hypercapnia and score above 23 points on the Nijmegen questionnaire\n* Present any contraindication regarding the WB-EMS/EMS\n* Viral o bacterial infections\n* Arterial circulatory disorders, advanced arteriosclerosis\n* Women during their menstrual period\n* Type I diabetes, hemophilia, bruises, bleeding, cognitive deficit, fibromyalgia, congenital diseases with muscle-skeletal alterations at the level of the back and lower extremities, scoliosis, protrusion or disc herniation, medication consumption, abdominal surgeries (scars or keloids), abdominal muscle injury.\n* Presence of chronic low back, hip or thigh pain'}, 'identificationModule': {'nctId': 'NCT05117203', 'briefTitle': 'Dynamic Electrostimulation on the Abdominal Muscles in Healthy Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de León'}, 'officialTitle': 'Immediate Effects of Dynamic Electrostimulation on the Abdominal Muscles in Healthy Individuals, Assessed by Ultrasound: an Experimental Study', 'orgStudyIdInfo': {'id': 'ETICA-ULE-009-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WB-EMS group', 'interventionNames': ['Device: WB-EMS (Whole body electrostimulation)']}, {'type': 'EXPERIMENTAL', 'label': 'EMS group', 'interventionNames': ['Device: EMS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Device: WB-EMS off']}], 'interventions': [{'name': 'WB-EMS (Whole body electrostimulation)', 'type': 'DEVICE', 'description': 'Application of physical exercise and electrical stimulation on the abdominal muscles through the WB-EMS during 20 minutes training session with specific exercise (CORE)', 'armGroupLabels': ['WB-EMS group']}, {'name': 'EMS', 'type': 'DEVICE', 'description': 'Application of physical exercise and electrical stimulation on the abdominal muscles through the EMS during 20 minutes training session with specific exercise (CORE)', 'armGroupLabels': ['EMS group']}, {'name': 'WB-EMS off', 'type': 'DEVICE', 'otherNames': ['Control group'], 'description': 'Application of physical exercise without electrical stimulation on the abdominal muscles through the WB-EMS off during a 20 minutes training session with specific exercise (CORE).', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24401', 'city': 'Ponferrada', 'state': 'León', 'country': 'Spain', 'facility': 'Universidad de León', 'geoPoint': {'lat': 42.54664, 'lon': -6.59619}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de León', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lorena Álvarez del Barrio', 'investigatorAffiliation': 'Universidad de León'}}}}