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临床试验/NCT04174664
NCT04174664Unknown不适用

Comparison of Different Functional Capacity Tests in Cystic Fibrosis Patients With Acute Pulmonary Exacerbation

Hacettepe University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
26
试验地点
1
主要终点
1 minute sit to stand test (STS) repetitions

研究概览

简要总结

The aim of this study to investigate and compare functional capacity with different tests and to evaluate the relationship between functional capacity and quality of life during acute pulmonary exacerbation in children with cystic fibrosis.

Exercise tests associated with prognostic values in CF patients and decreased exercise capacity has been correlated with a reduction in health-related quality of life. Pulmonary functions, functional capacity and quality of life will examine in this study.

详细描述

This study will be participated children with cystic fibrosis who will diagnosed acute pulmonary exacerbation. Patients' pulmonary function test, functional capacity will be assess and record at hospital admission and hospital discharge and outpatient clinic control. Quality of life will be evaluated at only outpatient clinic control .

Pulmonary function test will be assessed with spirometry, functional capacity will be evaluated with 1-minute sit to stand test and 3-minute step test. And quality of life will be evaluated Cystic Fibrosis Questionnaire-Revised (CFQ-R).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
7 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Childrens with CF diagnosed between 7-18 years of age and hospitalized due to acute pulmonary exacerbation will be included in the study.The diagnosis of acute pulmonary exacerbation will be established by Fuchs criteria.

排除标准

  • Patients with allergic bronchopulmonary aspergillosis (ABPA) who were treated with systemic steroid therapy and noninvasive mechanical ventilation support will not be included in the study.

结局指标

主要结局

1 minute sit to stand test (STS) repetitions

时间窗: November 2019- January 2021

number of STS completed at hospital admissions, hospital discharge and outpatient time

Quality of life assesment

时间窗: November 2019- January 2021

Cystic Fibrosis Questionnaire-Revised (CFQ-R) included 4 different age. These versions are teen/adult version,child version,parent version for children, preschool version. Scores range from 0 to 100, with higher scores indicating better health. This questionnaire will be filled only once.

pulmonary functions

时间窗: November 2019- January 2021

pulmonary functions assessment via spirometry

3 minute step test

时间窗: November 2019- January 2021

number of completed step at hospital admissions, hospital discharge and outpatient time

次要结局

  • Heart rate(November 2019- January 2021)
  • oxygen saturation(November 2019- January 2021)
  • dyspnea(November 2019- January 2021)
  • quadriceps fatigue(November 2019- January 2021)
  • Maximal heart rate(November 2019- January 2021)
  • fatigue(November 2019- January 2021)
  • hospitalization frequency(1 year)

研究者

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

Kübra Kılıç

MSc, PT

Hacettepe University

研究点 (1)

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