NCT07112703

Effect of Incentive Respiratory Training on Pulmonary Functions and Functional Capacity in Children With B-thalassemia Major

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Rawan Mohammed Khairy Mostafa Elsawy · Academic / Other
• Sex: All
• Age: 6 Years – 10 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Incentive Spirometer
• Pulmonary Function
• Functional Capacity
• Child, Only
• Thalassemia Major

Interventions

Type	Name	Description
OTHER	Incentive spirometer exercises	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.
OTHER	Diaphragmatic breathing	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.
OTHER	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	Costal breathing exercises	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.

Timeline

• Start date: 2025-04-07
• Primary completion: 2025-09-20
• Completion: 2025-10-08
• First posted: 2025-08-08
• Last updated: 2025-08-08

Locations

1 site across 1 country: Egypt