Clinical trial NCT05494333: Correlation Between Pulmonary Functions and Physical Fitness in Children With β-thalassemia
Official title: Correlation Between Pulmonary Functions and Physical Fitness in Children With β-thalassemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: β-Thalassemia
Pulmonary Function
Physical Fitness
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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

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

Primary outcomes:
measure: assessment of pulmonary functions by spirometer
timeFrame: baseline - one hour for each participant
measure: physical fitness
timeFrame: baseline - one hour for each participant
measure: cardiorespiratory fitness
timeFrame: baseline - one hour for each participant
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Esraa Elsayed
Study officials:
affiliation: Cairo University
name: esraa elsayed
role: PRINCIPAL_INVESTIGATOR
References: