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

Cairo University (CU)

Status: Enrolling

Conditions: Pulmonary Function; Physical Fitness; β-Thalassemia

Treatments: Other: no intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05494333

P.T.REC\012\003478

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 1 patient group

2

Description:

NO INTERVENTION

Treatment:

Other: no intervention