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

• Sponsor: Cairo University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05494333
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 10

Study Details

Study Description

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	Phase
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

1. 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

• Study Type: Observational
• Anticipated 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: Aug 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
2 NO INTERVENTION	Other: no intervention; NO intervention

Outcome Measures

Primary Outcome Measures

1. assessment of pulmonary functions by spirometer [baseline - one hour for each participant]

   measurements difference in vital capacity and minute ventilation

2. physical fitness [baseline - one hour for each participant]

   functional capacity by 6 minute walk test

3. cardiorespiratory fitness [baseline - one hour for each participant]

   measure by 3 minutes step test to monitor recovery of heart rate after stress test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Esraa Elsayed	Cairo		Egypt

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: esraa elsayed, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Aug 9, 2022
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Thalassemia; beta-Thalassemia

Study Results

No Results Posted as of Aug 9, 2022