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

• Conditions: Cystic Fibrosis in Children; Exercise Capacity

• Registration Number: NCT04174664
• Lead Sponsor: Hacettepe University

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).

Study Timeline

• Status Verified: 2019-11
• Study Start: 2019-11-01
• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-20
• Last Update Submitted: 2019-11-20
• Study First Posted: 2019-11-22
• Last Update Posted: 2019-11-22
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 minute sit to stand test (STS) repetitions	November 2019- January 2021	number of STS completed at hospital admissions, hospital discharge and outpatient time
Quality of life assesment	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	November 2019- January 2021	pulmonary functions assessment via spirometry
3 minute step test	November 2019- January 2021	number of completed step at hospital admissions, hospital discharge and outpatient time

Secondary Outcome Measures

Name	Time	Method
Heart rate	November 2019- January 2021	difference pre and post test heart beat number
oxygen saturation	November 2019- January 2021	difference pre and post test percentage of oxygen saturation
dyspnea	November 2019- January 2021	difference pre and post test breathlessness with Visual Analogue Scale (VAS).Scores range from 0 to 10, with higher scores indicating worse outcome.
quadriceps fatigue	November 2019- January 2021	difference pre and post test quadriceps fatigue with Visual Analogue Scale (VAS).Scores range from 0 to 10, with higher scores indicating worse outcome.
Maximal heart rate	November 2019- January 2021	maximal heart rate during 3-minute step test
fatigue	November 2019- January 2021	difference pre and post test fatigue with Visual Analogue Scale (VAS).Scores range from 0 to 10, with higher scores indicating worse outcome.
hospitalization frequency	1 year	number of hospitalization per year

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey