NCT Number: NCT07112703
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. To detect the level of oxygen saturation and heart rate during and after blood transfusion in children with β-thalassemia major.
Interested in participating?
Request Info6 year–10 year
All sexes
Interventional
Not applicable
Zagazig, Egypt
Location status: Recruiting
Eman Ebrahim El-hadidy, Professor
PRINCIPAL_INVESTIGATOR
Manal Salah ELdeen Abdel Wahab, Professor
PRINCIPAL_INVESTIGATOR
Rawan Muhammed Khairy, physical therapist
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
Time frame: before exercises and immediately after blood transfusion
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.
Time frame: before exercises and immediately after blood transfusion
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.
Time frame: before exercises and immediately after blood transfusion
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.
Time frame: before exercises and immediately after blood transfusion
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.
Contact information is provided by the study sponsor or research team.
Rawan Mohammed Khairy Mostafa Elsawy
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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