Correlation Between Pulmonary Functions and Physical Fitn... | NCT05494333

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

NCT05494333

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Aug 9, 2022Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

β-Thalassemia
Pulmonary Function
Physical Fitness

Interventions

no intervention

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2022Actual

Primary Completion Date

Oct 1, 2022Estimated

Completion Date

Dec 1, 2022Estimated

First Submitted Date

Jul 30, 2022

First Submission Date that Met QC Criteria

Aug 8, 2022

First Posted Date

Aug 9, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2022

Last Update Posted Date

Aug 9, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aims of this study are:

To determine the correlation between pulmonary functions and physical fitness in children with β-thalassemia.
To differentiate between different types of B-thalassemia in both pulmonary functions and physical fitness

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

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).
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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2		NO INTERVENTION	Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	NO intervention	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Cohort study: cross-sectional design

A) Subjects:

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
esraa elsayed	Contact	0201098139534		esraaelsaidabaas@gmail.com
sheref abdelhai	Contact	0201026484308		dr.sherefshokry@icloud.com

Overall Officials

Name	Affiliation	Role
esraa elsayed	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Esraa Elsayed	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided