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

Exercise Capacity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04174664
• Other study ID #: GO 19/817
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Cystic Fibrosis in Children
• Exercise Capacity
• Fibrosis

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