Correlation Between Pulmonary Functions and Physical Fitness in Children With β-thalassemia
NCT ID: NCT05494333
Last Updated: 2022-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2022-08-01
2022-12-01
Brief Summary
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1. To determine the correlation between pulmonary functions and physical fitness in children with β-thalassemia.
2. To differentiate between different types of B-thalassemia in both pulmonary functions and physical fitness
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Detailed Description
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A) Subjects:
Sample 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.
They will be selected based on the following:
Inclusion criteria:
* age range from 6 to 12 years
* children with β-thalassemia major and intermediate of both sex and control healthy children of both sex
* They can follow instruction
Exclusive criteria:
Children will be excluded from the study if they have:
* Defined Cardiovascular or respiratory disorders.
* Renal failure
* Visual or hearing impairment, Mentally retarded children
* Myocardial infarction within the last month
* Unstable angina, Recent thoraco-abdominal surgery
* Thoracic or abdominal aneurysm or Current pneumothorax
II) Materials
1. 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).
2. 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
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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2
NO INTERVENTION
no intervention
NO intervention
Interventions
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no intervention
NO intervention
Eligibility Criteria
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Inclusion Criteria
* children with β-thalassemia major and intermediate of both sex and control healthy children of both sex
* They can follow instruction
Exclusion Criteria
* Renal failure
* Visual or hearing impairment, Mentally retarded children
* Myocardial infarction within the last month
* Unstable angina, Recent thoraco-abdominal surgery
* Thoracic or abdominal aneurysm or Current pneumothorax
6 Years
12 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Esraa Elsayed Abaas Awad
assistant lecture
Principal Investigators
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esraa elsayed
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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Esraa Elsayed
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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P.T.REC\012\003478
Identifier Type: -
Identifier Source: org_study_id
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