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

Physical Fitness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05494333
• Other study ID #: P.T.REC\012\003478
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• beta-Thalassemia
• Physical Fitness
• Pulmonary Function
• ß-Thalassemia
• Thalassemia

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