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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05494333
Recruitment Status : Recruiting
First Posted : August 9, 2022
Last Update Posted : August 9, 2022
Sponsor:
Information provided by (Responsible Party):
Esraa Elsayed Abaas Awad, Cairo University

Study Description
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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

Condition or disease Intervention/treatment
β-Thalassemia Pulmonary Function Physical Fitness Other: no intervention

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 Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Correlation Between Pulmonary Functions and Physical Fitness in Children With β-thalassemia
Actual Study Start Date : August 1, 2022
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
2
NO INTERVENTION
 Other: no intervention
NO intervention


Outcome Measures
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Primary Outcome Measures :
  1. assessment of pulmonary functions by spirometer [ Time Frame: baseline - one hour for each participant ]
    measurements difference in vital capacity and minute ventilation

  2. physical fitness [ Time Frame: baseline - one hour for each participant ]
    functional capacity by 6 minute walk test

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05494333


Contacts
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Contact: esraa elsayed 0201098139534 esraaelsaidabaas@gmail.com
Contact: sheref abdelhai 0201026484308 dr.sherefshokry@icloud.com

Locations
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Egypt
Esraa Elsayed Recruiting
Cairo, Egypt
Contact: esraa elsayed    02 01098139534    esraaelsaidabaas@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: esraa elsayed Cairo University
More Information
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Responsible Party: Esraa Elsayed Abaas Awad, assistant lecture, Cairo University
ClinicalTrials.gov Identifier: NCT05494333    
Other Study ID Numbers: P.T.REC\012\003478
First Posted: August 9, 2022    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn