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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04174664
Enrollment
26
Registered
2019-11-22
Start date
2019-11-01
Completion date
2021-01-01
Last updated
2019-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis in Children, Exercise Capacity

Keywords

pulmonary exacerbation

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).

Interventions

DIAGNOSTIC_TEST1-minute sit to stand test

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

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
1 minute sit to stand test (STS) repetitionsNovember 2019- January 2021number of STS completed at hospital admissions, hospital discharge and outpatient time
3 minute step testNovember 2019- January 2021number of completed step at hospital admissions, hospital discharge and outpatient time
pulmonary functionsNovember 2019- January 2021pulmonary functions assessment via spirometry
Quality of life assesmentNovember 2019- January 2021Cystic 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.

Secondary

MeasureTime frameDescription
quadriceps fatigueNovember 2019- January 2021difference 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 rateNovember 2019- January 2021maximal heart rate during 3-minute step test
hospitalization frequency1 yearnumber of hospitalization per year
fatigueNovember 2019- January 2021difference pre and post test fatigue with Visual Analogue Scale (VAS).Scores range from 0 to 10, with higher scores indicating worse outcome.
Heart rateNovember 2019- January 2021difference pre and post test heart beat number
oxygen saturationNovember 2019- January 2021difference pre and post test percentage of oxygen saturation
dyspneaNovember 2019- January 2021difference pre and post test breathlessness with Visual Analogue Scale (VAS).Scores range from 0 to 10, with higher scores indicating worse outcome.

Countries

Turkey (Türkiye)

Contacts

Primary ContactKübra Kılıç, PhD Student
fztktas@gmail.com+903123051576
Backup ContactHacettepe University
+903123051576

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026