NCT04174664

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 22, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

1.2 years

First QC Date

November 13, 2019

Last Update Submit

November 20, 2019

Conditions

Cystic Fibrosis in ChildrenExercise Capacity

Keywords

pulmonary exacerbation

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (7)

  • Maximal heart rate

    November 2019- January 2021

  • Heart rate

    November 2019- January 2021

  • oxygen saturation

    November 2019- January 2021

  • dyspnea

    November 2019- January 2021

  • quadriceps fatigue

    November 2019- January 2021

  • +2 more secondary outcomes

Interventions

1-minute sit to stand testDIAGNOSTIC_TEST

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

Also known as: 3-minute step test, Quality of life, pulmonary function test

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Exercise TestRespiratory Function Tests

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Naciye Vardar-Yagli, PhD

    Hacettepe University

    STUDY DIRECTOR

  • 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

    STUDY CHAIR

  • Kubra Kilic, MSc

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kübra Kılıç, PhD Student

CONTACT

+903123051576fztktas@gmail.com

Hacettepe University

CONTACT

+903123051576

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, PT

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 22, 2019

Study Start

November 1, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

November 22, 2019

Record last verified: 2019-11

Locations

TU(1)