Beta Thalassemia MajorNCT06466304
Inspiratory Muscle Training in Children With Beta Thalasemia
A study testing inspiratory muscle training in people with Beta Thalassemia Major, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
respiratory complications are very prevalent in children with beta thalasemia major (BTM), so choosing inspiratory muscle trianing to decrease of prevent it and to improve pulmoanry funntions is important Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Beta Thalassemia Major
- What is being tested?
- inspiratory muscle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jun 2024to 1 Oct 2024
- Phase
- Interventional
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 40 beta thalassemia major children
- boys and girls
Who cannot join
- respiratory diseases
- cardiac diseases renal diseases liver diseases muscle and joint disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahram canadian university
Giza
hagar El-Hadidy, lecturer, hagarhadidy2016@gmail.com
About this study
respiratory complications are very prevalent in children with beta thalasemia major (BTM), so choosing inspiratory muscle trianing to decrease of prevent it and to improve pulmoanry funntions is important
Read the detailed description
children patients with BTM accounted 40 children will assigned to a group of inspiratory muscle training or waiting list group. the group will contain twenty children. the group of training will receive two session per day of training by threshold inspiratory muscle trainer ( for six day per week for 12 weeks)
- Conditions
- Beta Thalassemia Major
- Being tested
- inspiratory muscle training
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle trainingBehavioural
children patients with BTM accounted 20 children will receive two session per day of training by threshold inspiratory muscle trainer ( for six day per week for 12 weeks). the session will contain six sets of inspiratory muscle training and the one set will contain five respiratory cycles
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | children patients with BTM accounted 20 children will receive two session per day of training by threshold inspiratory muscle trainer ( for six day per week for 12 weeks). the session will contain six sets of inspiratory muscle training and the one set will contain five respiratory cycles Receives: Behavioral: inspiratory muscle training |
| control group | No intervention | children patients with BTM accounted 20 children will receive no trianiing and will serve as control children group |
What is being measured
The primary outcome is the main question the study is designed to answer.
forced expiratory volume t the first second of expiration
it will measure pulmonary function
Measured: it will be assessed after 12 weeks
Secondary outcomes (6)
forced vital capcity
it will measure pulmonary function
Measured: it will be assessed after 12 weeks
FEV1/FVC
it will measure pulmonary function
Measured: it will be assessed after 12 weeks
maximal inspiratory pressure
it will measure strength of inspiratory muscles
Measured: it will be assessed after 12 weeks
six minute walk testing
it will measure aerobic capacity
Measured: it will be assessed after 12 weeks
Pediatrics' Quality of Life Inventory (children proxy)
it will assess quality of life and filled by children
Measured: it will be assessed after 12 weeks
Pediatrics' Quality of Life Inventory (parent proxy)
it will assess quality of life and filled by parents of children
Measured: it will be assessed after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start6 Jun 2024
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta Thalassemia MajorStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Ahmed El-Hadidy, Ahram Canadian University
- Investigators
- hagar el-hadidy, lecturer, Principal investigator, Faculty of Physical Therapy, Ahram Canadian University (ACU), Giza, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466304
- Sponsor's protocol ID
- P.T -INT-06/2024- 544
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training in Children With Beta Thalasemia
- ClinicalTrials.gov ID
- NCT06466304
- Acronym / sponsor ID
- P.T -INT-06/2024- 544
- Conditions
- Beta Thalassemia Major
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 20 Jun 2024 (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.
respiratory complications are very prevalent in children with beta thalasemia major (BTM), so choosing inspiratory muscle trianing to decrease of prevent it and to improve pulmoanry funntions is important
Detailed description
children patients with BTM accounted 40 children will assigned to a group of inspiratory muscle training or waiting list group. the group will contain twenty children. the group of training will receive two session per day of training by threshold inspiratory muscle trainer ( for six day per week for 12 weeks)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Behavioral: inspiratory muscle trainingchildren patients with BTM accounted 20 children will receive two session per day of training by threshold inspiratory muscle trainer ( for six day per week for 12 weeks). the session will contain six sets of inspiratory muscle training and the one set will contain five respiratory cycles |
| control group | No intervention | –children patients with BTM accounted 20 children will receive no trianiing and will serve as control children group |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 40 beta thalassemia major children
- boys and girls
Key exclusion criteria (2 listed)
- respiratory diseases
- cardiac diseases renal diseases liver diseases muscle and joint disease
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 |
|---|---|---|
| inspiratory muscle trainingchildren patients with BTM accounted 20 children will receive two session per day of training by threshold inspiratory muscle trainer ( for six day per week for 12 weeks). the session will contain six sets of inspiratory muscle training and the one set will contain five respiratory cycles | Behavioural | study group |
Primary outcome
forced expiratory volume t the first second of expiration
Time frame: it will be assessed after 12 weeks
it will measure pulmonary function
6 secondary outcomes
forced vital capcity
Time frame: it will be assessed after 12 weeks
FEV1/FVC
Time frame: it will be assessed after 12 weeks
maximal inspiratory pressure
Time frame: it will be assessed after 12 weeks
six minute walk testing
Time frame: it will be assessed after 12 weeks
Pediatrics' Quality of Life Inventory (children proxy)
Time frame: it will be assessed after 12 weeks
Pediatrics' Quality of Life Inventory (parent proxy)
Time frame: it will be assessed after 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
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Growth and Development-related Outcomes in Children With Transfusion-dependent Beta-thalassemia After Gene Therapy
Transfusion-dependent Beta-Thalassemia, Gene Therapy
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Gene Therapy of Beta Thalassemia Using a Self-inactivating Lentiviral Vector
Beta-Thalassemia
RecruitingPhase 1/2
β-Thalassemia Treatment With KL003 Cell Injection
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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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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.
hagar el-hadidy, lecturer principal investigator
Faculty of Physical Therapy, Ahram Canadian University (ACU), Giza, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory muscle training in people with Beta Thalassemia Major, run by Ahram Canadian 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 2 inclusion and 2 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 20 Jun 2024. 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 hagar el-hadidy, lecturer (020100 745 3552, hagarhadidy2016@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
forced expiratory volume t the first second of expiration (time frame: it will be assessed after 12 weeks). 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 20 Jun 2024.