Clinical trial NCT04174664: Comparison of Different Functional Capacity Tests in Cystic Fibrosis Patients With Acute Pulmonary Exacerbation
Official title: Comparison of Different Functional Capacity Tests in Cystic Fibrosis Patients With Acute Pulmonary Exacerbation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystic Fibrosis in Children
Exercise Capacity
Keywords: pulmonary exacerbation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 26
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute pulmonary exacerbation in childrens with cystic fibrosis diagnosed according to Fuchs criteria.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: 1 minute sit to stand test (STS) repetitions
timeFrame: November 2019- January 2021
measure: 3 minute step test
timeFrame: November 2019- January 2021
measure: pulmonary functions
timeFrame: November 2019- January 2021
measure: Quality of life assesment
timeFrame: November 2019- January 2021
Secondary outcomes:
measure: Maximal heart rate
timeFrame: November 2019- January 2021
measure: Heart rate
timeFrame: November 2019- January 2021
measure: oxygen saturation
timeFrame: November 2019- January 2021
measure: dyspnea
timeFrame: November 2019- January 2021
measure: quadriceps fatigue
timeFrame: November 2019- January 2021
measure: fatigue
timeFrame: November 2019- January 2021
measure: hospitalization frequency
timeFrame: 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Naciye Vardar-Yagli, PhD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Deniz Inal-Ince, Professor
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Melda Saglam, PhD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Ebru Yalcin, Professor
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Dilber Ademhan-Tural, MD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Kubra Kilic, MSc
role: PRINCIPAL_INVESTIGATOR
References: