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Recruiting NCT07112703

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

No phase Interventional Incentive Spirometer Pulmonary Function Functional Capacity Child, Only

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Incentive spirometer exercises, Diaphragmatic breathing, Pursed lip breathing:, Costal breathing exercises.
Who it may be relevant to
Registry conditions: Incentive Spirometer, Pulmonary Function, Functional Capacity, Child, Only. Basic parameters: 6 years — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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.

Primary outcome measures

  • assessment of oxygen saturation [Time frame: before exercises and immediately after blood transfusion]
  • assessment of heart rate [Time frame: before exercises and immediately after blood transfusion]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Zagazig university hospitals. — Zagazig

Identifiers

NCT: NCT07112703 · Rawan_Phd

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗