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

NCT07112703 | Recruiting

• 1 other identifier: Rawan_Phd
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study was done to:

1. 1.Investigate the effect of respiratory training on functional lung capacity and
2. 2.To detect the effect of respiratory training on pulmonary functions in children with β-thalassemia major.
3. 3.To detect the level of oxygen saturation and heart rate during and after blood transfusion in children with β-thalassemia major.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  before exercises and immediately after blood transfusion

Secondary Outcomes (4)

• assessment of slow vital capacity

  before exercises and immediately after blood transfusion

• assessment of forced expiration

  before exercises and immediately after blood transfusion

• assessment of Maximal voluntary ventilation test

  before exercises and immediately after blood transfusion

• Assessment of functional capacity:

  before exercises and immediately after blood transfusion

Study Arms (2)

traditional breathing exercise

ACTIVE COMPARATOR

20 children will receive traditional breathing exercise for 30 minutes 2 times per month for 3 months.

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

Other: Incentive spirometer exercises; Other: Diaphragmatic breathing; Other: Pursed lip breathing:; Other: Costal breathing exercises

Interventions

Incentive spirometer exercises OTHER

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.

traditional breathing exercise and incentive spirometer breathing

Diaphragmatic breathing OTHER

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.

traditional breathing exercise; traditional breathing exercise and incentive spirometer breathing

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.

traditional breathing exercise; traditional breathing exercise and incentive spirometer breathing

Costal breathing exercises OTHER

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.

traditional breathing exercise; traditional breathing exercise and incentive spirometer breathing

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rawan Mohammed Khairy Mostafa Elsawy: lead
• Cairo University: collaborator

Study Sites (1)

Zagazig university hospitals.

Zagazig, Egypt

RECRUITING

MeSH Terms

Conditions

beta-Thalassemia

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Rawan Muhammed Khairy, physical therapist

CONTACT

01125492020; Roonyelsawy2@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: rawan mohamed khairy

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: August 8, 2025
• Study Start: April 7, 2025
• Primary Completion: September 20, 2025
• Study Completion: October 8, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

EG (1)