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临床试验/NCT07112703
NCT07112703招募中不适用

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

Rawan Mohammed Khairy Mostafa Elsawy1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年4月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
assessment of oxygen saturation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

traditional breathing exercise

Active Comparator

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

干预措施: Diaphragmatic breathing (Other)

traditional breathing exercise

Active Comparator

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

干预措施: Pursed lip breathing: (Other)

traditional breathing exercise

Active Comparator

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

干预措施: Costal breathing exercises (Other)

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

干预措施: Incentive spirometer exercises (Other)

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

干预措施: Diaphragmatic breathing (Other)

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

干预措施: Pursed lip breathing: (Other)

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

干预措施: Costal breathing exercises (Other)

结局指标

主要结局

assessment of oxygen saturation

时间窗: before exercises and immediately after blood transfusion

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.

assessment of heart rate

时间窗: before exercises and immediately after blood transfusion

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.

次要结局

  • 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)

研究者

发起方
Rawan Mohammed Khairy Mostafa Elsawy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rawan Mohammed Khairy Mostafa Elsawy

rawan mohamed khairy

Cairo University

研究点 (1)

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