Correlation Between Pulmonary Functions and Physical Fitness in Children With β-thalassemia
1 other identifier
observational
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedFirst Posted
Study publicly available on registry
August 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedAugust 9, 2022
August 1, 2022
2 months
July 30, 2022
August 8, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
assessment of pulmonary functions by spirometer
measurements difference in vital capacity and minute ventilation
baseline - one hour for each participant
physical fitness
functional capacity by 6 minute walk test
baseline - one hour for each participant
cardiorespiratory fitness
measure by 3 minutes step test to monitor recovery of heart rate after stress test
baseline - one hour for each participant
Study Arms (1)
2
NO INTERVENTION
Interventions
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Esraa Elsayed
Cairo, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
esraa elsayed
Cairo University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant lecture
Study Record Dates
First Submitted
July 30, 2022
First Posted
August 9, 2022
Study Start
August 1, 2022
Primary Completion
October 1, 2022
Study Completion
December 1, 2022
Last Updated
August 9, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share