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

• Sponsor: Hacettepe University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04174664
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis in Children; Exercise Capacity	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 Design

• Study Type: Observational
• Anticipated Enrollment: 26 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Comparison of Different Functional Capacity Tests in Cystic Fibrosis Patients With Acute Pulmonary Exacerbation
• Actual Study Start Date: Nov 1, 2019
• Anticipated Primary Completion Date: Jan 1, 2021
• Anticipated Study Completion Date: Jan 1, 2021

Outcome Measures

Primary Outcome Measures

1. 1 minute sit to stand test (STS) repetitions [November 2019- January 2021]

   number of STS completed at hospital admissions, hospital discharge and outpatient time

2. 3 minute step test [November 2019- January 2021]

   number of completed step at hospital admissions, hospital discharge and outpatient time

3. pulmonary functions [November 2019- January 2021]

   pulmonary functions assessment via spirometry

4. 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.

Secondary Outcome Measures

1. Maximal heart rate [November 2019- January 2021]

   maximal heart rate during 3-minute step test

2. Heart rate [November 2019- January 2021]

   difference pre and post test heart beat number

3. oxygen saturation [November 2019- January 2021]

   difference pre and post test percentage of oxygen saturation

4. 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.

5. 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.

6. 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.

7. hospitalization frequency [1 year]

   number of hospitalization per year

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hacettepe University	Ankara		Turkey

Sponsors and Collaborators

• Hacettepe University

Investigators

• Study Director: Naciye Vardar-Yagli, PhD, Hacettepe University
• Study Chair: Deniz Inal-Ince, Professor, Hacettepe University
• Study Chair: Melda Saglam, PhD, Hacettepe University
• Study Chair: Ebru Yalcin, Professor, Hacettepe University
• Study Chair: Dilber Ademhan-Tural, MD, Hacettepe University
• Principal Investigator: Kubra Kilic, MSc, Hacettepe University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kübra Kılıç, MSc, PT, Hacettepe University
• ClinicalTrials.gov Identifier: NCT04174664
• Other Study ID Numbers: GO 19/817
• First Posted: Nov 22, 2019
• Last Update Posted: Nov 22, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kübra Kılıç, MSc, PT, Hacettepe University: pulmonary exacerbation
• Additional relevant MeSH terms: Cystic Fibrosis; Fibrosis

Study Results

No Results Posted as of Nov 22, 2019