Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-03-30 @ 12:40 AM
Study NCT ID:
NCT06466304
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inspiratory Muscle Training in Children With Beta Thalasemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017086', 'term': 'beta-Thalassemia'}], 'ancestors': [{'id': 'D013789', 'term': 'Thalassemia'}, {'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-14', 'studyFirstSubmitDate': '2024-06-14', 'studyFirstSubmitQcDate': '2024-06-14', 'lastUpdatePostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'forced expiratory volume t the first second of expiration', 'timeFrame': 'it will be assessed after 12 weeks', 'description': 'it will measure pulmonary function'}], 'secondaryOutcomes': [{'measure': 'forced vital capcity', 'timeFrame': 'it will be assessed after 12 weeks', 'description': 'it will measure pulmonary function'}, {'measure': 'FEV1/FVC', 'timeFrame': 'it will be assessed after 12 weeks', 'description': 'it will measure pulmonary function'}, {'measure': 'maximal inspiratory pressure', 'timeFrame': 'it will be assessed after 12 weeks', 'description': 'it will measure strength of inspiratory muscles'}, {'measure': 'six minute walk testing', 'timeFrame': 'it will be assessed after 12 weeks', 'description': 'it will measure aerobic capacity'}, {'measure': "Pediatrics' Quality of Life Inventory (children proxy)", 'timeFrame': 'it will be assessed after 12 weeks', 'description': 'it will assess quality of life and filled by children'}, {'measure': "Pediatrics' Quality of Life Inventory (parent proxy)", 'timeFrame': 'it will be assessed after 12 weeks', 'description': 'it will assess quality of life and filled by parents of children'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Beta Thalassemia Major']}, 'descriptionModule': {'briefSummary': 'respiratory complications are very prevalent in children with beta thalasemia major (BTM), so choosing inspiratory muscle trianing to decrease of prevent it and to improve pulmoanry funntions is important', 'detailedDescription': 'children patients with BTM accounted 40 children will assigned to a group of inspiratory muscle training or waiting list group. the group will contain twenty children. the group of training will receive two session per day of training by threshold inspiratory muscle trainer ( for six day per week for 12 weeks)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'genderBased': True, 'genderDescription': 'self-representation of gender birth-certificate identity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 40 beta thalassemia major children\n* boys and girls\n\nExclusion Criteria:\n\n* respiratory diseases\n* cardiac diseases renal diseases liver diseases muscle and joint disease'}, 'identificationModule': {'nctId': 'NCT06466304', 'briefTitle': 'Inspiratory Muscle Training in Children With Beta Thalasemia', 'organization': {'class': 'OTHER', 'fullName': 'Ahram Canadian University'}, 'officialTitle': 'Inspiratory Muscle Training in Children With Beta Thalasemia', 'orgStudyIdInfo': {'id': 'P.T -INT-06/2024- 544'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'children patients with BTM accounted 20 children will receive two session per day of training by threshold inspiratory muscle trainer ( for six day per week for 12 weeks). the session will contain six sets of inspiratory muscle training and the one set will contain five respiratory cycles', 'interventionNames': ['Behavioral: inspiratory muscle training']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'children patients with BTM accounted 20 children will receive no trianiing and will serve as control children group'}], 'interventions': [{'name': 'inspiratory muscle training', 'type': 'BEHAVIORAL', 'description': 'children patients with BTM accounted 20 children will receive two session per day of training by threshold inspiratory muscle trainer ( for six day per week for 12 weeks). the session will contain six sets of inspiratory muscle training and the one set will contain five respiratory cycles', 'armGroupLabels': ['study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'hagar El-Hadidy, lecturer', 'role': 'CONTACT', 'email': 'hagarhadidy2016@gmail.com'}], 'facility': 'Ahram canadian university', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'hagar el-hadidy, lecturer', 'role': 'CONTACT', 'email': 'hagarhadidy2016@gmail.com', 'phone': '020100 745 3552'}, {'name': 'Shimaa Boundok, lectuerer', 'role': 'CONTACT', 'email': 'dr.shaimaa.bondok@dtu.edu.eg', 'phone': '01223749627'}], 'overallOfficials': [{'name': 'hagar el-hadidy, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Physical Therapy, Ahram Canadian University (ACU), Giza, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahram Canadian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physical Therapy for Internal Medicine and Geriatrics', 'investigatorFullName': 'Hagar Ahmed El-Hadidy', 'investigatorAffiliation': 'Ahram Canadian University'}}}}