Correlation Between Pulmonary Functions and Physical Fitness in Children With β-thalassemia

Study Overview
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Brief Summary
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The aims of this study are: To determine the correlation between pulmonary functions and physical fitness in children with β-thalassemia. To differentiate between different types of B-thalassemia in both pulmonary functions and physical fitness

Detailed Description
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Cohort study: cross-sectional design 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 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). 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

Official Title
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Correlation Between Pulmonary Functions and Physical Fitness in Children With β-thalassemia

Conditions
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β-Thalassemia, Pulmonary Function, Physical Fitness

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: • 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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 2<br>NO INTERVENTION | Other: no intervention<br>* NO intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of pulmonary functions by spirometer | measurements difference in vital capacity and minute ventilation | baseline - one hour for each participant | 
| physical fitness | functional capacity by 6 minute walk test | baseline - one hour for each participant | 
| cardiorespiratory fitness | measure by 3 minutes step test to monitor recovery of heart rate after stress test | baseline - one hour for each participant |