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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05494333
Enrollment
40
Registered
2022-08-09
Start date
2022-08-01
Completion date
2022-12-01
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Fitness, Pulmonary Function, β-Thalassemia

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

Interventions

OTHERno intervention

NO intervention

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
assessment of pulmonary functions by spirometerbaseline - one hour for each participantmeasurements difference in vital capacity and minute ventilation
physical fitnessbaseline - one hour for each participantfunctional capacity by 6 minute walk test
cardiorespiratory fitnessbaseline - one hour for each participantmeasure by 3 minutes step test to monitor recovery of heart rate after stress test

Countries

Egypt

Contacts

Primary Contactesraa elsayed
esraaelsaidabaas@gmail.com0201098139534
Backup Contactsheref abdelhai
dr.sherefshokry@icloud.com0201026484308

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026