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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Cystic Fibrosis in Children, Exercise Capacity

Intervention / Treatment
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* Diagnostic Test: 1-minute sit to stand test


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 minute sit to stand test (STS) repetitions | number of STS completed at hospital admissions, hospital discharge and outpatient time | November 2019- January 2021 | 
| 3 minute step test | number of completed step at hospital admissions, hospital discharge and outpatient time | November 2019- January 2021 | 
| pulmonary functions | pulmonary functions assessment via spirometry | November 2019- January 2021 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal heart rate | maximal heart rate during 3-minute step test | November 2019- January 2021 | 
| Heart rate | difference pre and post test heart beat number | November 2019- January 2021 | 
| oxygen saturation | difference pre and post test percentage of oxygen saturation | November 2019- January 2021 | 
| 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 | 
| 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 | 
| 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 | 
| hospitalization frequency | number of hospitalization per year | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary exacerbation