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

• Conditions: Pulmonary Function; Physical Fitness; β-Thalassemia
• Interventions: Other: no intervention

• Registration Number: NCT05494333
• Lead Sponsor: Cairo University

Brief 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

Study Timeline

• Study First Submitted: 2022-07-30
• Status Verified: 2022-08
• Study Start: 2022-08-01
• Study First Submitted QC: 2022-08-08
• Last Update Submitted: 2022-08-08
• Study First Posted: 2022-08-09
• Last Update Posted: 2022-08-09
• Primary Completion: 2022-10-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	no intervention	NO INTERVENTION

Primary Outcome Measures

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

Trial Locations

Locations (1)

Esraa Elsayed; 🇪🇬 Cairo, Egypt