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Clinical Trials/NCT05494333
NCT05494333
Unknown
Not Applicable

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

Cairo University1 site in 1 country40 target enrollmentAugust 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
β-Thalassemia
Sponsor
Cairo University
Enrollment
40
Locations
1
Primary Endpoint
assessment of pulmonary functions by spirometer
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
August 1, 2022
End Date
December 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Esraa Elsayed Abaas Awad

assistant lecture

Cairo University

Eligibility Criteria

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

Outcomes

Primary Outcomes

assessment of pulmonary functions by spirometer

Time Frame: baseline - one hour for each participant

measurements difference in vital capacity and minute ventilation

physical fitness

Time Frame: baseline - one hour for each participant

functional capacity by 6 minute walk test

cardiorespiratory fitness

Time Frame: baseline - one hour for each participant

measure by 3 minutes step test to monitor recovery of heart rate after stress test

Study Sites (1)

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