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临床试验/NCT06466304
NCT06466304招募中不适用

Inspiratory Muscle Training in Children With Beta Thalasemia

Ahram Canadian University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
forced expiratory volume t the first second of expiration

研究概览

简要总结

respiratory complications are very prevalent in children with beta thalasemia major (BTM), so choosing inspiratory muscle trianing to decrease of prevent it and to improve pulmoanry funntions is important

详细描述

children patients with BTM accounted 40 children will assigned to a group of inspiratory muscle training or waiting list group. the group will contain twenty children. the group of training will receive two session per day of training by threshold inspiratory muscle trainer ( for six day per week for 12 weeks)

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 (Outcomes Assessor)

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 40 beta thalassemia major children
  • boys and girls

排除标准

  • respiratory diseases
  • cardiac diseases renal diseases liver diseases muscle and joint disease

结局指标

主要结局

forced expiratory volume t the first second of expiration

时间窗: it will be assessed after 12 weeks

it will measure pulmonary function

次要结局

  • maximal inspiratory pressure(it will be assessed after 12 weeks)
  • forced vital capcity(it will be assessed after 12 weeks)
  • FEV1/FVC(it will be assessed after 12 weeks)
  • six minute walk testing(it will be assessed after 12 weeks)
  • Pediatrics' Quality of Life Inventory (children proxy)(it will be assessed after 12 weeks)
  • Pediatrics' Quality of Life Inventory (parent proxy)(it will be assessed after 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hagar Ahmed El-Hadidy

Physical Therapy for Internal Medicine and Geriatrics

Ahram Canadian University

研究点 (1)

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