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临床试验/NCT05494333
NCT05494333Unknown不适用

Correlation Between Pulmonary Functions and Physical Fitness in Children With β-thalassemia

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
assessment of pulmonary functions by spirometer

研究概览

简要总结

The aims of this study are:

  1. To determine the correlation between pulmonary functions and physical fitness in children with β-thalassemia.
  2. To differentiate between different types of B-thalassemia in both pulmonary functions and physical fitness

详细描述

Cohort study: cross-sectional design

A) Subjects:

Sample size estimation will be carried out to determine the recruited number of children selected randomly. Each participant's caregiver will sign a consent form authorizing the participation of their children in this study.

They will be selected based on the following:

Inclusion criteria:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • • age range from 6 to 12 years
  • children with β-thalassemia major and intermediate of both sex and control healthy children of both sex
  • They can follow instruction

排除标准

  • • Defined Cardiovascular or respiratory disorders.
  • Renal failure
  • Visual or hearing impairment, Mentally retarded children
  • Myocardial infarction within the last month
  • Unstable angina, Recent thoraco-abdominal surgery
  • Thoracic or abdominal aneurysm or Current pneumothorax

结局指标

主要结局

assessment of pulmonary functions by spirometer

时间窗: baseline - one hour for each participant

measurements difference in vital capacity and minute ventilation

physical fitness

时间窗: baseline - one hour for each participant

functional capacity by 6 minute walk test

cardiorespiratory fitness

时间窗: baseline - one hour for each participant

measure by 3 minutes step test to monitor recovery of heart rate after stress test

次要结局

未报告次要终点

研究者

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

Esraa Elsayed Abaas Awad

assistant lecture

Cairo University

研究点 (1)

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