Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT05494333
Status:
UNKNOWN
Last Update Posted:
2022-08-09
First Post:
2022-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlation Between Pulmonary Functions and Physical Fitness in Children With β-thalassemia
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Correlation Between Pulmonary Functions and Physical Fitness in Children With β-thalassemia
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: