NCT05494333

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

Summary

The aims of this study are: 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

Detailed description

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 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

• β-Thalassemia
• Pulmonary Function
• Physical Fitness

Interventions

Type	Name	Description
OTHER	no intervention	NO intervention

Timeline

• Start date: 2022-08-01
• Primary completion: 2022-10-01
• Completion: 2022-12-01
• First posted: 2022-08-09
• Last updated: 2022-08-09

Locations

1 site across 1 country: Egypt