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Идёт набор NCT07112703

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

Без фазы С лечением Incentive Spirometer Pulmonary Function Functional Capacity Child, Only

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Incentive spirometer exercises, Diaphragmatic breathing, Pursed lip breathing:, Costal breathing exercises.
Кому может быть актуально
Состояния в реестре: Incentive Spirometer, Pulmonary Function, Functional Capacity, Child, Only. Базовые параметры: 6 лет — 10 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.
  • Другое 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.
  • Другое 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.
  • Другое 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.

Первичные конечные точки

  • assessment of oxygen saturation [Срок оценки: before exercises and immediately after blood transfusion]
  • assessment of heart rate [Срок оценки: before exercises and immediately after blood transfusion]
Вторичные конечные точки (4)
  • assessment of slow vital capacity [Срок оценки: before exercises and immediately after blood transfusion]
  • assessment of forced expiration [Срок оценки: before exercises and immediately after blood transfusion]
  • assessment of Maximal voluntary ventilation test [Срок оценки: before exercises and immediately after blood transfusion]
  • Assessment of functional capacity: [Срок оценки: before exercises and immediately after blood transfusion]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Zagazig university hospitals. — Zagazig

Идентификаторы

NCT: NCT07112703 · Rawan_Phd

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗