Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-01-07 @ 8:35 PM
Study NCT ID:
NCT05494333
Status:
UNKNOWN
Last Update Posted:
2022-08-09
First Post:
2022-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Pulmonary Functions and Physical Fitness in Children With β-thalassemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-08', 'studyFirstSubmitDate': '2022-07-30', 'studyFirstSubmitQcDate': '2022-08-08', 'lastUpdatePostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assessment of pulmonary functions by spirometer', 'timeFrame': 'baseline - one hour for each participant', 'description': 'measurements difference in vital capacity and minute ventilation'}, {'measure': 'physical fitness', 'timeFrame': 'baseline - one hour for each participant', 'description': 'functional capacity by 6 minute walk test'}, {'measure': 'cardiorespiratory fitness', 'timeFrame': 'baseline - one hour for each participant', 'description': 'measure by 3 minutes step test to monitor recovery of heart rate after stress test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['β-Thalassemia', 'Pulmonary Function', 'Physical Fitness']}, 'descriptionModule': {'briefSummary': 'The aims of this study are:\n\n1. To determine the correlation between pulmonary functions and physical fitness in children with β-thalassemia.\n2. To differentiate between different types of B-thalassemia in both pulmonary functions and physical fitness', 'detailedDescription': "Cohort study: cross-sectional design\n\nA) Subjects:\n\nSample size estimation will be carried out to determine the recruited number of children selected randomly. Each participant's caregiver will sign a consent form authorizing the participation of their children in this study.\n\nThey will be selected based on the following:\n\nInclusion criteria:\n\n* age range from 6 to 12 years\n* children with β-thalassemia major and intermediate of both sex and control healthy children of both sex\n* They can follow instruction\n\nExclusive criteria:\n\nChildren will be excluded from the study if they have:\n\n* Defined Cardiovascular or respiratory disorders.\n* Renal failure\n* Visual or hearing impairment, Mentally retarded children\n* Myocardial infarction within the last month\n* Unstable angina, Recent thoraco-abdominal surgery\n* Thoracic or abdominal aneurysm or Current pneumothorax\n\nII) Materials\n\n1. For evaluation of pulmonary functions The measurements that are made include forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and the ratio of the two volumes (FEV1/FVC).\n2. For evaluation of physical fitness Aerobic capacity and endurance By 6-Minute Walk Test , 3 minutes step test and Energy expenditure BMI Balance Pediatric balance scale"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Cohort study: cross-sectional design\n\nA) Subjects:\n\nSample size estimation will be carried out to determine the recruited number of children selected randomly. Each participant's caregiver will sign a consent form authorizing the participation of their children in this study", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • age range from 6 to 12 years\n\n * children with β-thalassemia major and intermediate of both sex and control healthy children of both sex\n * They can follow instruction\n\nExclusion Criteria:\n\n* • Defined Cardiovascular or respiratory disorders.\n\n * Renal failure\n * Visual or hearing impairment, Mentally retarded children\n * Myocardial infarction within the last month\n * Unstable angina, Recent thoraco-abdominal surgery\n * Thoracic or abdominal aneurysm or Current pneumothorax'}, 'identificationModule': {'nctId': 'NCT05494333', 'briefTitle': 'Correlation Between Pulmonary Functions and Physical Fitness in Children With β-thalassemia', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Correlation Between Pulmonary Functions and Physical Fitness in Children With β-thalassemia', 'orgStudyIdInfo': {'id': 'P.T.REC\\012\\003478'}}, 'armsInterventionsModule': {'armGroups': [{'label': '2', 'description': 'NO INTERVENTION', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'NO intervention', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'esraa elsayed', 'role': 'CONTACT', 'email': 'esraaelsaidabaas@gmail.com', 'phone': '02 01098139534'}], 'facility': 'Esraa Elsayed', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'esraa elsayed', 'role': 'CONTACT', 'email': 'esraaelsaidabaas@gmail.com', 'phone': '0201098139534'}, {'name': 'sheref abdelhai', 'role': 'CONTACT', 'email': 'dr.sherefshokry@icloud.com', 'phone': '0201026484308'}], 'overallOfficials': [{'name': 'esraa elsayed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecture', 'investigatorFullName': 'Esraa Elsayed Abaas Awad', 'investigatorAffiliation': 'Cairo University'}}}}