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Clinical Trials/NCT04174664
NCT04174664
Unknown
Not Applicable

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

Hacettepe University1 site in 1 country26 target enrollmentNovember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cystic Fibrosis in Children
Sponsor
Hacettepe University
Enrollment
26
Locations
1
Primary Endpoint
1 minute sit to stand test (STS) repetitions
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
November 1, 2019
End Date
January 1, 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kübra Kılıç

MSc, PT

Hacettepe University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

1 minute sit to stand test (STS) repetitions

Time Frame: November 2019- January 2021

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

Quality of life assesment

Time Frame: 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

Time Frame: November 2019- January 2021

pulmonary functions assessment via spirometry

3 minute step test

Time Frame: November 2019- January 2021

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

Secondary Outcomes

  • 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)

Study Sites (1)

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