Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-02-24 @ 3:15 PM
Study NCT ID:
NCT06647667
Status:
COMPLETED
Last Update Posted:
2024-10-18
First Post:
2024-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Interval Versus Moderate Intensity Continuous Training on Soluble st2 Biomarkers in Chronic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-11', 'size': 593543, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-15T06:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1. Patients will receive high intensity interval training (HIIT)\n2. Patients will receive moderate intensity continuous training (MICT)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-15', 'studyFirstSubmitDate': '2024-06-14', 'studyFirstSubmitQcDate': '2024-10-15', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'soluble ST2 biomarker level', 'timeFrame': 'before the start of the trail and at the end of the trail 3 months', 'description': 'sample was taken at the cubited vein at the beginning of the program and also at its end'}], 'secondaryOutcomes': [{'measure': 'ejection fraction', 'timeFrame': 'before the start of the trail and at the end of the trail 3 months', 'description': 'Left ventricular systolic dysfunction was assessed using the ejection fraction by 2D simpson method'}, {'measure': 'mannisota of daily living questionnaire score', 'timeFrame': 'before the start of the trail and at the end of the trail 3 months', 'description': 'The twenty one item questionnaire was usedfrom 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL), as well as scores for two dimensions, physical (8 items, range 0-40) and emotional (5 items, range 0-25). The other eight items (of the total of 21) are only considered for the calculation of the total score.'}, {'measure': 'peak exercise response', 'timeFrame': 'before the start of the trail and at the end of the trail 3 months', 'description': 'monitoring the peak exercise response'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sST2 biomarker', 'Minnesota Questionare', 'HIITS'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'This study was designed to compare between the effect of high intensity interval training (HIIT) and moderate intensity continuous training (MICT) on soluble ST2 biomarkers among chronic heart failure patients, also measure the improvement in the quality of life with different modes of exercise and with of it is more benifitial for the heart failure patient', 'detailedDescription': 'The data concerned with the study including soluble ST2 biomarker levels, ejection fraction and MLHFQ was measured before and after twelve weeks of treatment.In this study a total sixty male patients with chronic heart failure NYHA class (I \\&II) were selected from the outpatient clinic, El-Demerdash hospital, Ain-shams University. Their age ranged from 50-60 years. Patients were randomly assigned into two groups, group A receiving HIIT along with prescribed medical treatment and group B receiving MCT along with prescribed medical treatment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patients selection was according to the following criteria:\n\n * Patients diagnosed with chronic heart failure (New York heart association class I\\& II) with systolic left ventricular dysfunction.\n * Their left ventricular ejection fraction (LVEF) \\<40%.\n * Medical treatment was optimized at least three months prior to study entry.\n * All patients didn't participate in any rehabilitation programs prior to the study.\n\nExclusion Criteria:\n\n* Patients who had met one of the following criteria were excluded from the study:\n\n 1. Signs of acute heart failure, unstable angina or severe arrhythmia three months prior to enrolment in the study.\n 2. Pacemakers.\n 3. Chronic obstructive pulmonary disease.\n 4. Other disorders counteracting exercise testing conditions that limit lower limb mobility (for example, burns, fractures)\n 5. Pre-existing neuromuscular diseases (for example Myasthenia Gravis)."}, 'identificationModule': {'nctId': 'NCT06647667', 'briefTitle': 'High Interval Versus Moderate Intensity Continuous Training on Soluble st2 Biomarkers in Chronic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'High Interval Versus Moderate Intensity Continuous Training on Soluble st2 Biomarkers in Chronic Heart Failure', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group A', 'description': 'high intensity interval training', 'interventionNames': ['Other: HIITS']}, {'type': 'EXPERIMENTAL', 'label': 'group B', 'description': 'moderate intensity continuous training', 'interventionNames': ['Other: MICT']}], 'interventions': [{'name': 'HIITS', 'type': 'OTHER', 'description': 'Frequency: HIIT will be in 2 supervised sessions per week for 12 weeks on the treadmill.\n\nsession duration from 30-40 min including the waming up and cooling down Intensity: HIIT included 4 minute intervals aiming 60-85% of heart rate reserve', 'armGroupLabels': ['group A']}, {'name': 'MICT', 'type': 'OTHER', 'description': 'Frequency: Moderate continuous training is scheduled 2 times per week for 12 weeks.\n\nIntensity: exercise had been applied on the treadmill with 40%-59% of heart rate reserve) session duration from 30-40 min including the warming up and cooling down', 'armGroupLabels': ['group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Faculty of physical therapy Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Donia M Elmasry, Doctorate', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'August 2024 till December 2024', 'ipdSharing': 'YES', 'description': 'study protocol and final results', 'accessCriteria': 'researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD candidate', 'investigatorFullName': 'Dina Reda Ali', 'investigatorAffiliation': 'Cairo University'}}}}