Incentive SpirometerNCT07112703
Effect of Incentive Respiratory Training on Pulmonary Functions and Functional Capacity in Children With B-thalassemia Major
A study testing Incentive spirometer exercises, Diaphragmatic breathing and Pursed lip breathing: in people with Incentive Spirometer and Pulmonary Function, run by Rawan Mohammed Khairy Mostafa Elsawy at 1 site in Egypt.
Trial summary
The study was done to: 1. Investigate the effect of respiratory training on functional lung capacity and 2. To detect the effect of respiratory training on pulmonary functions in children with β-thalassemia major. 3. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Incentive Spirometer, Pulmonary Function, Functional Capacity
- What is being tested?
- Incentive spirometer exercises, Diaphragmatic breathing and Pursed lip breathing:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Apr 2025to 8 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed as thalassemia \& subjected to blood transfusion
- Their age range from 6 to 10 years old
- Both sexes, male and female, will participate.
- Subjects are able to follow simple verbal commands or instructions included in the procedures.
Who cannot join
- Children with mental retardation or any other disability .
- Children with visual or hearing defects.
- Children with cardiovascular, chest pulmonary, and heart diseases.
- Children with any postoperative cardiovascular, chest pulmonary, and heart conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig university hospitals.
Zagazig
Rawan Muhammed Khairy, physical therapist, 01125492020, Roonyelsawy2@gmail.com
Eman Ebrahim El-hadidy, Professor
About this study
The study was done to:
- Investigate the effect of respiratory training on functional lung capacity and
- To detect the effect of respiratory training on pulmonary functions in children with β-thalassemia major.
- To detect the level of oxygen saturation and heart rate during and after blood transfusion in children with β-thalassemia major.
Read the detailed description
Children with thalassemia require regular blood transfusions, which can lead to complications and affect lung capacity, oxygen saturation, and heart rate. To improve lung function capacity, this study aims to enhance physical fitness for children with B-thalassemia major, enabling optimal performance in daily activities and leisure activities. Physical activity focused on fitness is essential for children to find pleasure in physical activities and improve oxygen saturation levels. This study may also help physiotherapists understand the importance of improving lung function capacity for children with B-major thalassemia.
- Conditions
- Incentive Spirometer, Pulmonary Function, Functional Capacity, Child, Only, Thalassemia Major
- Being tested
- Incentive spirometer exercises, Diaphragmatic breathing, Pursed lip breathing:, Costal breathing exercises
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentive spirometer exercisesOther
The study group was instructed to use an incentive spirometer, which should be held upright, sealed around the mouthpiece, and taken slowly and deep breaths. They will be motivated to achieve a preset volume through visual feedback. The child will hold their breath for 2-3 seconds at full inspiration and, after each set of 10 breaths, cough to clear mucus from the lungs. The exercise duration is 15 minutes.
Diaphragmatic breathingOther
The child will lie on their back, place one hand on their belly and one on their chest, and use a balloon or doll to fill both belly and chest up like a balloon. Inhale deeply, let the hands on the belly rise, then exhale slowly, making the belly down. The exercise will last for 10 minutes.
Pursed lip breathing:Other
Sit in a seated position with crossed legs or knees. Inhale slowly through the nose for three seconds, then exhale through pursed lips, similar to blowing out birthday candles.
Costal breathing exercisesOther
The study involves conducting Costal breathing exercises for children. The exercises involve placing hands on the apical region of the lung, turning the child's head, relaxing the shoulder and neck muscles, taking a deep breath, pushing the hand out, holding, and exhaling slowly. The hands provide pressure and resistance after initiation of inspiration, and the children rest for 2 minutes between exercises. The duration of the exercise varies between the control and study groups.
| Study group | Role | What they receive |
|---|---|---|
| traditional breathing exercise | Active comparator | 20 children will receive traditional breathing exercise for 30 minutes 2 times per month for 3 months. Receives: Other: Diaphragmatic breathing; Other: Pursed lip breathing:; Other: Costal breathing exercises |
| traditional breathing exercise and incentive spirometer breathing | Experimental | 20 children who will receive traditional breathing exercise for 15 minutes and breathing exercises by incentive spirometer for 15 minutes 2 times per month for 3 months Receives: Other: Incentive spirometer exercises; Other: Diaphragmatic breathing; Other: Pursed lip breathing:; Other: Costal breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of oxygen saturation
A child should rest for five minutes before taking an oximeter reading. The meter should be placed on the child's fingertip, and if the numbers fluctuate, the oxygen saturation level will be clearly labeled on the screen device.
Measured: before exercises and immediately after blood transfusion
assessment of heart rate
A child should rest for five minutes before taking an oximeter reading. The meter should be placed on the child's fingertip, and if the numbers fluctuate, the heart rate level will be clearly labeled on the screen device.
Measured: before exercises and immediately after blood transfusion
Secondary outcomes (4)
assessment of slow vital capacity
Using neuro-soft spirometer. The process involves calibrating an instrument, data entry, and child preparation for measurements. Calibration involves removing the mouthpiece, attaching it to the flow sensor, and adjusting the device pump. Data entry involves sterilizing the mouthpiece and entering patient information. Assessment procedures involve sitting comfortably, recording data, performing test maneuvers, and repeating the test if results aren't acceptable.
The child is instructed to take two to three normal breaths, exhale slowly and inhale gently, with a diagram displayed on the screen to measure their breathing strength. The record icon is closed after the test, and 1-2 minutes of rest is allowed between measurements.
Measured: before exercises and immediately after blood transfusion
assessment of forced expiration
Using neuro-soft spirometer. The process involves calibrating an instrument, data entry, and child preparation for measurements. Calibration involves removing the mouthpiece, attaching it to the flow sensor, and adjusting the device pump. Data entry involves sterilizing the mouthpiece and entering patient information. Assessment procedures involve sitting comfortably, recording data, performing test maneuvers, and repeating the test if results aren't acceptable.
A forced expiration test involves a child taking two to three breaths, inhaling deeply, and blowing air through the mouthpiece until no air is left. A candle is shown on the screen to motivate the child. The test is repeated three times, and the record icon is closed.
Measured: before exercises and immediately after blood transfusion
assessment of Maximal voluntary ventilation test
Using neuro-soft spirometer. The process involves calibrating an instrument, data entry, and child preparation for measurements. Calibration involves removing the mouthpiece, attaching it to the flow sensor, and adjusting the device pump. Data entry involves sterilizing the mouthpiece and entering patient information. Assessment procedures involve sitting comfortably, recording data, performing test maneuvers, and repeating the test if results aren't acceptable.
A maximal voluntary ventilation test is conducted by inhaling and exhaling rapidly for 10 seconds, with a diagram showing inspiration and expiration strength. The record icon is closed after 10 seconds, and the test is repeated three times.
Measured: before exercises and immediately after blood transfusion
Assessment of functional capacity:
The study uses a six-minute walk test to assess children's functional capacity. The child walks on a 10 meter unobstructed path, with a therapist monitoring their progress. They cover as many turns as possible without running. Chairs are placed at each 5 meter distance for rest and recovery.
Measured: before exercises and immediately after blood transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start7 Apr 2025
- Primary completion20 Sep 2025 (estimated)
- Study completion8 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incentive SpirometerStudies 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
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rawan Mohammed Khairy Mostafa Elsawy
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Rawan Mohammed Khairy Mostafa Elsawy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112703
- Sponsor's protocol ID
- Rawan_Phd
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Incentive Respiratory Training on Pulmonary Functions and Functional Capacity in Children With B-thalassemia Major
- ClinicalTrials.gov ID
- NCT07112703
- Acronym / sponsor ID
- Rawan_Phd
- Conditions
- Incentive Spirometer, Pulmonary Function, Functional Capacity, Child, Only, Thalassemia Major
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rawan Mohammed Khairy Mostafa ElsawyUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 8 Oct 2025 (estimated)
- First posted
- 8 Aug 2025 (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 study was done to:
- Investigate the effect of respiratory training on functional lung capacity and
- To detect the effect of respiratory training on pulmonary functions in children with β-thalassemia major.
- To detect the level of oxygen saturation and heart rate during and after blood transfusion in children with β-thalassemia major.
Detailed description
Children with thalassemia require regular blood transfusions, which can lead to complications and affect lung capacity, oxygen saturation, and heart rate. To improve lung function capacity, this study aims to enhance physical fitness for children with B-thalassemia major, enabling optimal performance in daily activities and leisure activities. Physical activity focused on fitness is essential for children to find pleasure in physical activities and improve oxygen saturation levels. This study may also help physiotherapists understand the importance of improving lung function capacity for children with B-major thalassemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional breathing exercise | Active comparator | Other: Diaphragmatic breathing, Other: Pursed lip breathing:, Other: Costal breathing exercises20 children will receive traditional breathing exercise for 30 minutes 2 times per month for 3 months. |
| traditional breathing exercise and incentive spirometer breathing | Experimental | Other: Incentive spirometer exercises, Other: Diaphragmatic breathing, Other: Pursed lip breathing:, Other: Costal breathing exercises20 children who will receive traditional breathing exercise for 15 minutes and breathing exercises by incentive spirometer for 15 minutes 2 times per month for 3 months |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosed as thalassemia \& subjected to blood transfusion
- Their age range from 6 to 10 years old
- Both sexes, male and female, will participate.
- Subjects are able to follow simple verbal commands or instructions included in the procedures.
Key exclusion criteria (4 listed)
- Children with mental retardation or any other disability .
- Children with visual or hearing defects.
- Children with cardiovascular, chest pulmonary, and heart diseases.
- Children with any postoperative cardiovascular, chest pulmonary, and heart conditions.
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 |
|---|---|---|
| Incentive spirometer exercisesThe study group was instructed to use an incentive spirometer, which should be held upright, sealed around the mouthpiece, and taken slowly and deep breaths. They will be motivated to achieve a preset volume through visual feedback. The child will hold their breath for 2-3 seconds at full inspiration and, after each set of 10 breaths, cough to clear mucus from the lungs. The exercise duration is 15 minutes. | Other | traditional breathing exercise and incentive spirometer breathing |
| Diaphragmatic breathingThe child will lie on their back, place one hand on their belly and one on their chest, and use a balloon or doll to fill both belly and chest up like a balloon. Inhale deeply, let the hands on the belly rise, then exhale slowly, making the belly down. The exercise will last for 10 minutes. | Other | traditional breathing exercise, traditional breathing exercise and incentive spirometer breathing |
| Pursed lip breathing:Sit in a seated position with crossed legs or knees. Inhale slowly through the nose for three seconds, then exhale through pursed lips, similar to blowing out birthday candles. | Other | traditional breathing exercise, traditional breathing exercise and incentive spirometer breathing |
| Costal breathing exercisesThe study involves conducting Costal breathing exercises for children. The exercises involve placing hands on the apical region of the lung, turning the child's head, relaxing the shoulder and neck muscles, taking a deep breath, pushing the hand out, holding, and exhaling slowly. The hands provide pressure and resistance after initiation of inspiration, and the children rest for 2 minutes between exercises. The duration of the exercise varies between the control and study groups. | Other | traditional breathing exercise, traditional breathing exercise and incentive spirometer breathing |
Primary outcome
assessment of oxygen saturation
Time frame: before exercises and immediately after blood transfusion
A child should rest for five minutes before taking an oximeter reading. The meter should be placed on the child's fingertip, and if the numbers fluctuate, the oxygen saturation level will be clearly labeled on the screen device.
assessment of heart rate
Time frame: before exercises and immediately after blood transfusion
A child should rest for five minutes before taking an oximeter reading. The meter should be placed on the child's fingertip, and if the numbers fluctuate, the heart rate level will be clearly labeled on the screen device.
4 secondary outcomes
assessment of slow vital capacity
Time frame: before exercises and immediately after blood transfusion
assessment of forced expiration
Time frame: before exercises and immediately after blood transfusion
assessment of Maximal voluntary ventilation test
Time frame: before exercises and immediately after blood transfusion
Assessment of functional capacity:
Time frame: before exercises and immediately after blood transfusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
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Incentive Spirometer, Diaphragmatic Breathing
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incentive spirometer exercises, Diaphragmatic breathing and Pursed lip breathing: in people with Incentive Spirometer and Pulmonary Function, run by Rawan Mohammed Khairy Mostafa Elsawy 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 8 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rawan Muhammed Khairy, physical therapist (01125492020, Roonyelsawy2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of oxygen saturation (time frame: before exercises and immediately after blood transfusion). The study lists 2 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 8 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.