Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-02 @ 10:12 AM
Study NCT ID:
NCT05110404
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2021-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COMPARISON BETWEEN TWO SUB-TYPES OF HIGH INTENSITY INTERVAL TRAINING
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-20', 'studyFirstSubmitDate': '2021-10-21', 'studyFirstSubmitQcDate': '2021-11-02', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'body mass index', 'timeFrame': '12 weeks', 'description': 'change in body mass index'}, {'measure': 'waist circumference', 'timeFrame': '12 weeks', 'description': 'change in waist circumference'}, {'measure': 'waist/hip ratio', 'timeFrame': '12 weeks', 'description': 'change in waist/hip ratio'}, {'measure': 'Systolic and diastolic blood pressure', 'timeFrame': '12 weeks', 'description': 'change in Systolic and diastolic blood pressure'}, {'measure': 'HbA1c', 'timeFrame': '12 weeks', 'description': 'change in HbA1c'}, {'measure': 'fasting & 2-h post prandial blood glucose', 'timeFrame': '12 weeks', 'description': 'change in fasting \\& 2-h post prandial blood glucose'}, {'measure': 'fasting lipid profile', 'timeFrame': '12 weeks', 'description': 'change in fasting lipid profile'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DM'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '37954548', 'type': 'DERIVED', 'citation': 'Ahmad AM, Mahmoud AM, Serry ZH, Mohamed MM, Abd Elghaffar HA. Effects of low-versus high-volume high-intensity interval training on glycemic control and quality of life in obese women with type 2 diabetes. A randomized controlled trial. J Exerc Sci Fit. 2023 Oct;21(4):395-404. doi: 10.1016/j.jesf.2023.08.003. Epub 2023 Aug 30.'}]}, 'descriptionModule': {'briefSummary': 'Recently, HIIT has been recommended by the American diabetes association for type 2 diabetes. The high-volume HIIT has been studied extensively in patients with type 2 diabetes, however, little is known about the effectiveness of low-volume HIIT regarding target glycemic or lipid control in these patients. Therefore, the purpose of this study is to compare between two subtypes of HIIT (i.e. the low-volume HIIT versus the high-volume HIIT) with respect to exercise-induced changes in blood glucose, lipid profile and anthropometry in patients with type 2 diabetes mellitus. Statement of the Problem Is there any difference between the effect of high-volume and the low-volume high intensity interval training on glycemic and lipids control in type 2 diabetes?\n\nPurpose of the study:\n\nTo assess the effect of the high-volume versus the low-volume high intensity interval training on glycemic and blood lipids control in type 2 diabetes.\n\nNull Hypothesis:\n\nThere will be no difference between the effect of the high-volume versus the low-volume high intensity interval training on glycemic and blood lipids control in type 2 diabetes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Type II diabetes mellitus diagnosed by a physician as having HbA 1c of \\> 6.5%.\n2. An established diagnosis of T2DM for at least 1year and less than 5 years.\n3. Women patients.\n4. Age between 35 to 45 years old.\n5. Systolic Blood pressure less than or equal 130 mmHg.\n6. Obese patients (BMI is between 30 and 39.9 kg/m 2 )\n7. Patients with HbA 1c of 7-9%.\n8. A self-reported sedentary lifestyle.\n9. Patients receiving oral hypoglycemic medications described by the physician\n10. Patients with hyperlipidemia.\n\nExclusion Criteria:\n\n1. Patients with Cardiac diseases.\n2. Patients with glaucoma.\n3. Patients with diabetic complications (Diabetic foot, retinopathy, nephropathy, and diabetic peripheral neuropathy).\n4. Musculoskeletal or neurological limitations to physical exercise.\n5. Pregnancy\n6. Patients under insulin therapy\n7. Patients with poorly controlled DM (HbA1c \\> 9%)\n8. Bronchial asthma and chronic obstructive pulmonary disease.\n9. Smokers.\n10. Morbidly obese BMI ≥ 40 kg/m 2\n11. Males.\n\n11\\. Systolic Blood pressure more than 130 mmHg. 12. Anemia ( hemoglobin \\< 12 g/dL) 13. Osteopenia.'}, 'identificationModule': {'nctId': 'NCT05110404', 'briefTitle': 'COMPARISON BETWEEN TWO SUB-TYPES OF HIGH INTENSITY INTERVAL TRAINING', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'EFFECT OF HIGH VERSUS LOW-VOLUME HIGH INTENSITY INTERVAL TRAINING ON GLYCEMIC AND LIPIDS CONTROL IN TYPE 2 DIABETES', 'orgStudyIdInfo': {'id': 'P.T.REC/012/002900'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group (A): The high-volume HIIT', 'description': 'Exercise group A (n=30): It will include patients that will perform high-volume high-intensity interval training (HIIT), and will receive medical intervention.', 'interventionNames': ['Other: The high-volume HIIT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group (B): The low-volume HIIT', 'description': 'Exercise group B (n=30): will receive medical intervention. that will perform the low-volume high-intensity interval training, and will receive medical intervention.', 'interventionNames': ['Other: The low-volume HIIT']}, {'type': 'NO_INTERVENTION', 'label': 'Group C', 'description': 'patients will receive medical intervention only.'}], 'interventions': [{'name': 'The high-volume HIIT', 'type': 'OTHER', 'description': 'patients will undergo a warm up at 65%-70% of HRpeak for 5 minutes, and then they will walk on a treadmill for 4 intervals of 4 min each at an intensity corresponding to 85%-90% of HRpeak with 3 min active recovery interval interval in between at 65%-75% of HRpeak. Finally, a 3-min cool-down period will be permitted. The speed and the inclination of the treadmill will be adjusted between intervals to ensure that all patients are exercising at the desired target heart rate monitored by Pulse Oximeter.', 'armGroupLabels': ['Group (A): The high-volume HIIT']}, {'name': 'The low-volume HIIT', 'type': 'OTHER', 'description': 'Each session will start with a 5-minute warm up at 65-70% of peak HR. Then they will walk on a treadmill for 4 intervals of 2 min each at an intensity corresponding to 85%-90% of HRpeak with three intervals of active recovery in between for 2 min at 65%-75% of HRpeak. Finally, a 3-min cool-down period will be permitted.', 'armGroupLabels': ['Group (B): The low-volume HIIT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Physical Therapy cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "physiotherapist holds a master's degree in Physical therapy for Cardiovascular, Respiratory disorders and geriatrics, Faculty of physical therapy, Cairo university.", 'investigatorFullName': 'Asmaa Mohamed Mahmoud Mohamed', 'investigatorAffiliation': 'Cairo University'}}}}