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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05494333
Other study ID # P.T.REC\012\003478
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2022
Est. completion date December 1, 2022

Study information

Verified date August 2022
Source Cairo University
Contact esraa elsayed
Phone 0201098139534
Email esraaelsaidabaas@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 1, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria: - • age range from 6 to 12 years - children with ß-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


Intervention

Other:
no intervention
NO intervention

Locations

Country Name City State
Egypt Esraa Elsayed Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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