Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-01-02 @ 9:34 AM
Study NCT ID:
NCT03936803
Status:
COMPLETED
Last Update Posted:
2019-11-13
First Post:
2019-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interval Training Versus Electro Acupuncture on Liver Functions in Patients With Non-alcoholic Fatty Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-10', 'studyFirstSubmitDate': '2019-04-30', 'studyFirstSubmitQcDate': '2019-05-02', 'lastUpdatePostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'body mass index', 'timeFrame': 'about 4 weeks', 'description': 'was used for measuring the weight and height of each patient to calculate the body mass index (BMI) (figure). BMI = weight kg / (height m)2'}, {'measure': 'lab investigations', 'timeFrame': 'about 12 weeks', 'description': 'lab investigation of aminotransferase (ALT) iu/l and Aspartate aminotransferase (AST) iu/l There was a subjective evaluation of the level of exhaustion throw observation of ventilation, walking action and fascial expression in patients at the end stage of test.\n\n* Subjects initially performed submaximal exercise stress test (increasing 1 W every 2 s) on an electronically braked cycle ergometer to determine sub maximum heart rate.'}, {'measure': 'lab investigations', 'timeFrame': 'about 14weeks', 'description': 'lab investigation of Triglycerides (TG) mg/dl and c-reactive protein mg/l'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Alcoholic Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': 'in this study, the investigators compare the effect of interval training exercise and electroacupuncture on liver functions in non-alcoholic fatty liver disease patients', 'detailedDescription': 'fifty patients suffering from Nonalcoholic fatty liver disease (NAFLD) will be recruited in this study with age ranged from 30-55 years old from both sexes, chosen from internal medicine department at Kasr El Aini hospital and from the outpatient clinic of nutrition and cardiovascular disorders at the faculty of Physical Therapy Cairo University, they were divided in to two groups:Group (1):\n\nTwenty-five patients suffering from Nonalcoholic fatty liver disease (NAFLD), and taking their standard medications In addition to electroacupuncture at points of LR3 (Taichong), LR14 (Qimen), GB 34(Yanglingquan) and ST36 (Zu San Li). Group (2):\n\nTwenty-five patients suffering from Nonalcoholic fatty liver disease(NAFLD) and taking their standard medications in addition to aerobic interval training exercise.Lab investigations of:\n\nAspartate aminotransferase (AST), Alanine aminotransferase (ALT), Triglycerides (TG) and C-reactive protein (CRP).to judge liver functions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Sixty patients suffering from Nonalcoholic fatty liver disease (NAFLD).\n2. Their age will be ranged from 30-55 years old.\n3. Body mass index (30 - 40)\n4. All patients are medically stable.\n\nExclusion Criteria:\n\n* Patients with Hepatitis C \\& b\n* Acute and chronic significant illnesses that may interfere with actual training, severe ventricular arrhythmia, hemodynamic deterioration or exercise-induced arrhythmia at baseline testing.\n* Co-morbidities that limit exercise tolerance (hemoglobin 10 g/dl, a chronic obstructive pulmonary disease with FEV1 50%).\n* Hypertension (resting blood pressure \\>140/90 mmHg).\n* Heart failure, inability to exercise, or drug abuse.\n* Pacemakers\n* Pregnancy\n* Epileptic Seizures\n* Cancer'}, 'identificationModule': {'nctId': 'NCT03936803', 'briefTitle': 'Interval Training Versus Electro Acupuncture on Liver Functions in Patients With Non-alcoholic Fatty Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Interval Training Versus Electro Acupuncture on Liver Functions in Patients With Non-alcoholic Fatty Liver Disease', 'orgStudyIdInfo': {'id': 'P.T.REC/012/001579'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'exercise group', 'description': 'Twenty-five patients suffering from Nonalcoholic fatty liver disease (NAFLD) and taking their standard medications in addition to aerobic interval training exercise .Its consisted of cycle ergometer training, 3 days a week for 6 weeks. Aerobic interval training consisted of ( 8 )minutes warm-up, followed by 4 times of 4-minute intervals with heart rate (HR) at 85% of sub maximum HR, with active pauses of 3 minutes of walking at 60% of sub maximum heart rate HR. The exercise session was terminated by 5 minutes cool-down', 'interventionNames': ['Behavioral: aerobic interval training exercise .']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'electro-acupuncture group', 'description': 'Twenty-five patients suffering from Nonalcoholic fatty liver disease (NAFLD), and taking their standard medications In addition to electro acupuncture (EA) of (2 Hz, 4 mA) was applied at points of: liver 3 (LR3) ,liver 14 (LR14), gall bladder 34 (GB 34) and stomach 36 (ST36) .\n\nDuration of the session was 15 min / each, three sessions per week for six weeks', 'interventionNames': ['Device: electro acupuncture']}], 'interventions': [{'name': 'aerobic interval training exercise .', 'type': 'BEHAVIORAL', 'description': 'Its consisted of cycle ergometer training, 3 days a week for 6 weeks. Aerobic interval training consisted of ( 8 )minutes warm-up, followed by 4 times of 4-minute intervals with HR at 85% of sub maximum HR, with active pauses of 3 minutes of walking at 60% of sub maximum HR. The exercise session was terminated by 5 minutes cool-down', 'armGroupLabels': ['exercise group']}, {'name': 'electro acupuncture', 'type': 'DEVICE', 'description': 'electroacupuncture (EA) of (2 Hz, 4 mA) was applied at points of:liver 3 LR3,liver 14 LR 14, gall bladder 34 (GB 34) and stomach 36 (ST36) .\n\nDuration of the session was 15 min / each, three sessions per week for six weeks', 'armGroupLabels': ['electro-acupuncture group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'faculty of physical therapy Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'zahra 63 serry, prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ramy Salama Atia Draz', 'investigatorAffiliation': 'Cairo University'}}}}