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

August 8, 2022 updated by: Esraa Elsayed Abaas Awad, Cairo University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
2
NO INTERVENTION
Other: no intervention
NO intervention

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: esraa elsayed, Cairo university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

July 30, 2022

First Submitted That Met QC Criteria

August 8, 2022

First Posted (Actual)

August 9, 2022

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC\012\003478

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Function

Clinical Trials on no intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe