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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-10
SponsorRawan Mohammed Khairy Mostafa Elsawy

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Incentive spirometer exercises

    Other intervention

    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 breathing

    Other intervention

    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 intervention

    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 exercises

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: traditional breathing exerciseActive comparator 3 interventions
Group B: traditional breathing exercise and incentive spirometer breathingExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
before exercises and immediately after blood transfusion
2

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.

Time frame
before exercises and immediately after blood transfusion

Secondary outcomes

1

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.

Time frame
before exercises and immediately after blood transfusion
2

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.

Time frame
before exercises and immediately after blood transfusion
3

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.

Time frame
before exercises and immediately after blood transfusion
4

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.

Time frame
before exercises and immediately after blood transfusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rawan Mohammed Khairy Mostafa Elsawy

Lead sponsor

Cairo University

Sponsor institution

Cairo University

Collaborator