β-ThalassemiaNCT05494333
Correlation Between Pulmonary Functions and Physical Fitness in Children With β-thalassemia
An observational study of β-Thalassemia and Pulmonary Function, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- β-Thalassemia, Pulmonary Function, Physical Fitness
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- • 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Esraa Elsayed
Cairo
esraa elsayed, 02 01098139534, esraaelsaidabaas@gmail.com
About this study
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
Read the detailed description
Cohort study: cross-sectional design
- 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
- Conditions
- β-Thalassemia, Pulmonary Function, Physical Fitness
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
NO intervention
| Study group | Role | What they receive |
|---|---|---|
| 2 | NO INTERVENTION Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of pulmonary functions by spirometer
measurements difference in vital capacity and minute ventilation
Measured: baseline - one hour for each participant
physical fitness
functional capacity by 6 minute walk test
Measured: baseline - one hour for each participant
cardiorespiratory fitness
measure by 3 minutes step test to monitor recovery of heart rate after stress test
Measured: baseline - one hour for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Aug 2022
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for β-ThalassemiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Elsayed Abaas Awad, Cairo University
- Investigators
- esraa elsayed, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494333
- Sponsor's protocol ID
- P.T.REC\012\003478
- Status last verified
- Aug 2022
- First submitted
- 30 Jul 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Pulmonary Functions and Physical Fitness in Children With β-thalassemia
- ClinicalTrials.gov ID
- NCT05494333
- Acronym / sponsor ID
- P.T.REC\012\003478
- Conditions
- β-Thalassemia, Pulmonary Function, Physical Fitness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | – | Other: no interventionNO INTERVENTION |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (3 listed)
- • age range from 6 to 12 years
Key exclusion criteria (6 listed)
- • Defined Cardiovascular or respiratory disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionNO intervention | Other | 2 |
Primary outcome
assessment of pulmonary functions by spirometer
Time frame: baseline - one hour for each participant
measurements difference in vital capacity and minute ventilation
physical fitness
Time frame: baseline - one hour for each participant
functional capacity by 6 minute walk test
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: No
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A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)
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A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)
Transfusion-dependent Alpha-Thalassemia, Transfusion-dependent Beta-Thalassemia
Active, not recruitingPhase 3
A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)
Transfusion-dependent Alpha-Thalassemia, Transfusion-dependent Beta-Thalassemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
esraa elsayed principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of β-Thalassemia and Pulmonary Function, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact esraa elsayed (0201098139534, esraaelsaidabaas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of pulmonary functions by spirometer (time frame: baseline - one hour for each participant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.