Cystic Fibrosis in ChildrenNCT04174664
Comparison of Different Functional Capacity Tests in Cystic Fibrosis Patients With Acute Pulmonary Exacerbation
An observational study of Cystic Fibrosis in Children and Exercise Capacity, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Cystic Fibrosis in Children, Exercise Capacity
- What is being tested?
- 1-minute sit to stand test
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Acute pulmonary exacerbation in childrens with cystic fibrosis diagnosed according to Fuchs criteria.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hacettepe University contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara
Kubra Kilic, MsC, +903123051576, fztktas@gmail.com
Hacettepe University, +903123051576
About this study
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.
Read the 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).
- Conditions
- Cystic Fibrosis in Children, Exercise Capacity
- Being tested
- 1-minute sit to stand test
- Keywords
- pulmonary exacerbation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-minute sit to stand testDiagnostic test
Also called 3-minute step test, Quality of life, pulmonary function test
Childrens will complete 1-minute sit to stand test and 3 minute step test and quality of life questionnaire.
What is being measured
The primary outcome is the main question the study is designed to answer.
1 minute sit to stand test (STS) repetitions
number of STS completed at hospital admissions, hospital discharge and outpatient time
Measured: November 2019- January 2021
3 minute step test
number of completed step at hospital admissions, hospital discharge and outpatient time
Measured: November 2019- January 2021
pulmonary functions
pulmonary functions assessment via spirometry
Measured: 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.
Measured: November 2019- January 2021
Secondary outcomes (7)
Maximal heart rate
maximal heart rate during 3-minute step test
Measured: November 2019- January 2021
Heart rate
difference pre and post test heart beat number
Measured: November 2019- January 2021
oxygen saturation
difference pre and post test percentage of oxygen saturation
Measured: 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.
Measured: 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.
Measured: 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.
Measured: November 2019- January 2021
hospitalization frequency
number of hospitalization per year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start1 Nov 2019
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis in ChildrenStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Kılıç, Hacettepe University
- Investigators
- Naciye Vardar-Yagli, PhD, Study director, Hacettepe UniversityDeniz Inal-Ince, Professor, Study chair, Hacettepe UniversityMelda Saglam, PhD, Study chair, Hacettepe UniversityEbru Yalcin, Professor, Study chair, Hacettepe UniversityDilber Ademhan-Tural, MD, Study chair, Hacettepe UniversityKubra Kilic, MSc, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174664
- Sponsor's protocol ID
- GO 19/817
- Status last verified
- Nov 2019
- First submitted
- 13 Nov 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Functional Capacity Tests in Cystic Fibrosis Patients With Acute Pulmonary Exacerbation
- ClinicalTrials.gov ID
- NCT04174664
- Acronym / sponsor ID
- GO 19/817
- Conditions
- Cystic Fibrosis in Children, Exercise Capacity
- Keywords
- pulmonary exacerbation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Acute pulmonary exacerbation in childrens with cystic fibrosis diagnosed according to Fuchs criteria.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1-minute sit to stand testAlso: 3-minute step test, Quality of life, pulmonary function testChildrens will complete 1-minute sit to stand test and 3 minute step test and quality of life questionnaire. | Diagnostic test | – |
Primary outcome
1 minute sit to stand test (STS) repetitions
Time frame: November 2019- January 2021
number of STS completed at hospital admissions, hospital discharge and outpatient time
3 minute step test
Time frame: November 2019- January 2021
number of completed step at hospital admissions, hospital discharge and outpatient time
pulmonary functions
Time frame: November 2019- January 2021
pulmonary functions assessment via spirometry
Quality of life assesment
Time frame: 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.
7 secondary outcomes
Maximal heart rate
Time frame: November 2019- January 2021
Heart rate
Time frame: November 2019- January 2021
oxygen saturation
Time frame: November 2019- January 2021
dyspnea
Time frame: November 2019- January 2021
quadriceps fatigue
Time frame: November 2019- January 2021
fatigue
Time frame: November 2019- January 2021
hospitalization frequency
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Cystic Fibrosis in Children
RecruitingObservational study
TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age
Cystic Fibrosis (CF)
Recruiting
Exercise in Child Health
Cystic Fibrosis, Sickle Cell Disease
Not yet recruiting
Reproducibility of Continuous Glucose Monitoring (CGM) in the Assessment of Glucose Metabolism Disorders in Children With Cystic Fibrosis
Glucose Metabolism Disorders in Cystic Fibrosis
RecruitingObservational study
Sinus Disease in Young Children With Cystic Fibrosis
Cystic Fibrosis in Children, Cystic Fibrosis
Active, not recruitingPhase 4
Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER)
Cystic Fibrosis, Cystic Fibrosis Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hacettepe University contact
Naciye Vardar-Yagli, PhD study director
Hacettepe University
Deniz Inal-Ince, Professor study chair
Hacettepe University
Melda Saglam, PhD study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis in Children and Exercise Capacity, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kübra Kılıç, PhD Student (+903123051576, fztktas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 minute sit to stand test (STS) repetitions (time frame: November 2019- January 2021). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.