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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04174664
Other study ID # GO 19/817
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date January 1, 2021

Study information

Verified date November 2019
Source Hacettepe University
Contact Kübra Kiliç, PhD Student
Phone +903123051576
Email fztktas@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 26
Est. completion date January 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group 7 Years to 18 Years
Eligibility 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.

Study Design


Intervention

Diagnostic Test:
1-minute sit to stand test
Childrens will complete 1-minute sit to stand test and 3 minute step test and quality of life questionnaire.

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 1 minute sit to stand test (STS) repetitions number of STS completed at hospital admissions, hospital discharge and outpatient time November 2019- January 2021
Primary 3 minute step test number of completed step at hospital admissions, hospital discharge and outpatient time November 2019- January 2021
Primary pulmonary functions pulmonary functions assessment via spirometry November 2019- January 2021
Primary Quality of life assesment 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. November 2019- January 2021
Secondary Maximal heart rate maximal heart rate during 3-minute step test November 2019- January 2021
Secondary Heart rate difference pre and post test heart beat number November 2019- January 2021
Secondary oxygen saturation difference pre and post test percentage of oxygen saturation November 2019- January 2021
Secondary dyspnea difference pre and post test breathlessness with Visual Analogue Scale (VAS).Scores range from 0 to 10, with higher scores indicating worse outcome. November 2019- January 2021
Secondary quadriceps fatigue difference pre and post test quadriceps fatigue with Visual Analogue Scale (VAS).Scores range from 0 to 10, with higher scores indicating worse outcome. November 2019- January 2021
Secondary fatigue difference pre and post test fatigue with Visual Analogue Scale (VAS).Scores range from 0 to 10, with higher scores indicating worse outcome. November 2019- January 2021
Secondary hospitalization frequency number of hospitalization per year 1 year
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