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

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.

Study Overview

• Status: Unknown
• Conditions: Exercise Capacity; Cystic Fibrosis in Children
• Intervention / Treatment: Diagnostic test: 1-minute sit to stand test

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 Type: Observational
• Enrollment (Anticipated): 26

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Acute pulmonary exacerbation in childrens with cystic fibrosis diagnosed according to Fuchs criteria.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Chair: Dilber Ademhan-Tural, MD, Hacettepe University; Principal Investigator: Kubra Kilic, MSc, Hacettepe University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2019
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): January 1, 2021

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (ACTUAL): November 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 20, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: pulmonary exacerbation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: GO 19/817

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No