Cystic FibrosisNCT04259983
Investigation of Relationship Between Vascular Functions, Exercise Capacity, and Respiratory Functions in CF
An observational study of Cystic Fibrosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
In the literature, there is no study that evaluates the endothelial function and arterial stiffness together and investigates its relationship with exercise capacity and respiratory functions in children with CF of different obstruction severities. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Maximal exercise test, Endothelial dysfunction assessment and Arterial stiffness assessment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Apr 2022to 2 May 2023
- How long will I take part?
- 1 Day
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children who are diagnosed with Cystic Fibrosis with different obstruction severity at Hacettepe University Faculty of Medicine, Department of Pediatric Chest Diseases and who reffered to the Cardiopulmonary Rehabilitation Unit for Physiotherapy also who are willing to participate in the study will be include in the study.
Who may be able to join
- Being clinically stable
- To be cooperated in evaluations to be made
- Forced expiratory volume in the first second (FEV1)> 40%
- No exacerbation in the past three months
- Regular medication for the past 12 months
- No medication changes for at least three weeks
Who cannot join
- Cardiovascular disease
- Hypertension
- Diabetes
- Pulmonary hypertension
- Smoking
- Resting oxygen saturation (SpO2) <92%
Show all 11Show fewer
- Using vasoactive drugs (nitrates, b-blockers, angiotensin-converting enzyme inhibitors, etc.)
- Using oral steroids
- Undergoing lung surgery
- Being a highly orthopedic, neurological disease
- Injury to the lower extremity such as injury, sprain, or fracture in the past six months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara
About this study
Official title: Investigation of the Relationship Between Micro and Macrovascular Functions and Exercise Capacity and Respiratory Functions in Children With Cystic Fibrosis of Different Obstruction Severities
In the literature, there is no study that evaluates the endothelial function and arterial stiffness together and investigates its relationship with exercise capacity and respiratory functions in children with CF of different obstruction severities. Therefore, the aim of this study is to investigate and compare microvascular (endothelium), macrovascular (arterial stiffness) functions in children with CF of different obstruction severities, and to investigate the relationship between micro and macrovascular functions and exercise capacity and respiratory functions in children with CF of different obstruction severities.
Read the detailed description
Cystic fibrosis (CF) is a rare disease with congenital deterioration in mucociliary clearance that causes recurrent or chronic rhinosinusitis, airway infection and bronchiectasis in pediatric age. There are pulmonary genetic disorders associated with inflammation. Children with CF have been shown to have vascular endothelial dysfunction compared to healthy children. Very young children with CF have been reported to have increased arterial stiffness and some decrease in right-left ventricular function. In another study on the subject, it was found that stiffness of the great arteries increased in children with CF; The change in arterial compliancy has been shown to be significant in childhood. The increase in arterial stiffness is associated with systemic inflammation, regardless of blood pressure or diabetes. Hemodynamic changes have been reported in the presence of systemic inflammation in children with CF. Exercise peak workload in children with CF is known to be associated with endothelial dysfunction. It is not known how exercise capacity is affected by endothelial dysfunction and arterial stiffness in CF patients of varying severity. In the literature, there are no studies comparing endothelial function, arterial stiffness and its effect on exercise capacity and pulmonary functions in CF children; this subject is open to research. The aim of this study was to investigate and compare microvascular (peripheral endothelial), macrovascular (arterial stiffness) functions in children with CF and to investigate the relationship of micro and macrovascular functions with exercise capacity and pulmonary functions in children with CF of different obstruction severities.
- Conditions
- Cystic Fibrosis
- Being tested
- Maximal exercise test, Endothelial dysfunction assessment, Arterial stiffness assessment
- Keywords
- Endothelial Dysfunction, Arterial Stiffness, Exercise Capacity, Respiratory Functions, Children
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal exercise testOther
The maximal exercise test will be performed on an electronically braked bicycle ergometer.
Endothelial dysfunction assessmentOther
Endothelial dysfunction will be determined by blood samples. Blood samples will be collected and analyzed for the responses of ICAM-1, VCAM-1, E-Selectin, VEGF, ET-1.
Arterial stiffness assessmentOther
Arterial stiffness, oscillometric pulse wave velocity (PWV) and augmentation index will be evaluated by recorded brachial pulse waves with automatically with the oscillometric device.
| Study group | Role | What they receive |
|---|---|---|
| Patients with CF with normal obstruction severity | In CF children with normal obstruction severity will be subjected to the same maximal exercise test, endothelial dysfunction and arterial stiffness assessments. Receives: Other: Maximal exercise test; Other: Endothelial dysfunction assessment; Other: Arterial stiffness assessment | |
| Patients with CF with mild obstruction severity | In CF children with mild obstruction severity will be subjected to the same maximal exercise test, endothelial dysfunction and arterial stiffness assessments. Receives: Other: Maximal exercise test; Other: Endothelial dysfunction assessment; Other: Arterial stiffness assessment | |
| Patients with CF with moderate obstruction severity | In CF children with moderate obstruction severity will be subjected to the same maximal exercise test, endothelial dysfunction and arterial stiffness assessments. Receives: Other: Maximal exercise test; Other: Endothelial dysfunction assessment; Other: Arterial stiffness assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal exercise capacity
The maximal exercise test will be performed on an electronically braked bicycle ergometer using the Godfrey protocol. The peak work capacity (Wzirve) measurement will be expressed as a percentage of normal values.
Measured: Maximal exercise test will be performed on the first day
Endothelial dysfunction
Endothelial dysfunction will be determined by intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), E-selectin, Vascular endothelial growth factor (VEGF), Endothelin-1 (ET-1). Blood samples will be collected.
Measured: Endothelial dysfunction assessment will be performed on the first day
Arterial stiffness
Arterial stiffness, oscillometric pulse wave velocity (PWV) (m s - 1) and augmentation index (AI@75) (%) will be evaluated by recorded brachial pulse waves with automatically with the oscillometric device.
Measured: Arterial stiffness assessment will be performed on the first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start11 Apr 2022
- Primary completion8 Dec 2022
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Senem Simsek, Hacettepe University
- Investigators
- Deniz Inal-Ince, PhD, Study director, Hacettepe UniversitySenem Simsek, MSc, Principal investigator, Hacettepe UniversityElmas Ebru Gunes-Yalcin, PhD, Principal investigator, Hacettepe UniversityMurat Timur Budak, PhD, Principal investigator, Hacettepe UniversityNagehan Emiralioglu, PhD, Principal investigator, Hacettepe UniversityAslihan Cakmak, MSc, Principal investigator, Hacettepe UniversityYasemin Kartal, MSc, Principal investigator, Hacettepe UniversitySuna Sabuncuoğlu, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259983
- Sponsor's protocol ID
- GO19/1156
- Status last verified
- Nov 2023
- First submitted
- 28 Jan 2020
- Last updated
- 6 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Micro and Macrovascular Functions and Exercise Capacity and Respiratory Functions in Children With Cystic Fibrosis of Different Obstruction Severities
- ClinicalTrials.gov ID
- NCT04259983
- Acronym / sponsor ID
- GO19/1156
- Conditions
- Cystic Fibrosis
- Keywords
- Endothelial Dysfunction, Arterial Stiffness, Exercise Capacity, Respiratory Functions, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 7 Feb 2020 (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.
In the literature, there is no study that evaluates the endothelial function and arterial stiffness together and investigates its relationship with exercise capacity and respiratory functions in children with CF of different obstruction severities. Therefore, the aim of this study is to investigate and compare microvascular (endothelium), macrovascular (arterial stiffness) functions in children with CF of different obstruction severities, and to investigate the relationship between micro and macrovascular functions and exercise capacity and respiratory functions in children with CF of different obstruction severities.
Detailed description
Cystic fibrosis (CF) is a rare disease with congenital deterioration in mucociliary clearance that causes recurrent or chronic rhinosinusitis, airway infection and bronchiectasis in pediatric age. There are pulmonary genetic disorders associated with inflammation. Children with CF have been shown to have vascular endothelial dysfunction compared to healthy children. Very young children with CF have been reported to have increased arterial stiffness and some decrease in right-left ventricular function. In another study on the subject, it was found that stiffness of the great arteries increased in children with CF; The change in arterial compliancy has been shown to be significant in childhood. The increase in arterial stiffness is associated with systemic inflammation, regardless of blood pressure or diabetes. Hemodynamic changes have been reported in the presence of systemic inflammation in children with CF. Exercise peak workload in children with CF is known to be associated with endothelial dysfunction. It is not known how exercise capacity is affected by endothelial dysfunction and arterial stiffness in CF patients of varying severity. In the literature, there are no studies comparing endothelial function, arterial stiffness and its effect on exercise capacity and pulmonary functions in CF children; this subject is open to research. The aim of this study was to investigate and compare microvascular (peripheral endothelial), macrovascular (arterial stiffness) functions in children with CF and to investigate the relationship of micro and macrovascular functions with exercise capacity and pulmonary functions in children with CF of different obstruction severities.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with CF with normal obstruction severity | – | Other: Maximal exercise test, Other: Endothelial dysfunction assessment, Other: Arterial stiffness assessmentIn CF children with normal obstruction severity will be subjected to the same maximal exercise test, endothelial dysfunction and arterial stiffness assessments. |
| Patients with CF with mild obstruction severity | – | Other: Maximal exercise test, Other: Endothelial dysfunction assessment, Other: Arterial stiffness assessmentIn CF children with mild obstruction severity will be subjected to the same maximal exercise test, endothelial dysfunction and arterial stiffness assessments. |
| Patients with CF with moderate obstruction severity | – | Other: Maximal exercise test, Other: Endothelial dysfunction assessment, Other: Arterial stiffness assessmentIn CF children with moderate obstruction severity will be subjected to the same maximal exercise test, endothelial dysfunction and arterial stiffness assessments. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children who are diagnosed with Cystic Fibrosis with different obstruction severity at Hacettepe University Faculty of Medicine, Department of Pediatric Chest Diseases and who reffered to the Cardiopulmonary Rehabilitation Unit for Physiotherapy also who are willing to participate in the study will be include in the study.
Key inclusion criteria (6 listed)
- Being clinically stable
- To be cooperated in evaluations to be made
- Forced expiratory volume in the first second (FEV1)> 40%
- No exacerbation in the past three months
- Regular medication for the past 12 months
Key exclusion criteria (11 listed)
- Cardiovascular disease
- Hypertension
- Diabetes
- Pulmonary hypertension
- Smoking
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 |
|---|---|---|
| Maximal exercise testThe maximal exercise test will be performed on an electronically braked bicycle ergometer. | Other | Patients with CF with mild obstruction severity, Patients with CF with moderate obstruction severity, Patients with CF with normal obstruction severity |
| Endothelial dysfunction assessmentEndothelial dysfunction will be determined by blood samples. Blood samples will be collected and analyzed for the responses of ICAM-1, VCAM-1, E-Selectin, VEGF, ET-1. | Other | Patients with CF with mild obstruction severity, Patients with CF with moderate obstruction severity, Patients with CF with normal obstruction severity |
| Arterial stiffness assessmentArterial stiffness, oscillometric pulse wave velocity (PWV) and augmentation index will be evaluated by recorded brachial pulse waves with automatically with the oscillometric device. | Other | Patients with CF with mild obstruction severity, Patients with CF with moderate obstruction severity, Patients with CF with normal obstruction severity |
Primary outcome
Maximal exercise capacity
Time frame: Maximal exercise test will be performed on the first day
The maximal exercise test will be performed on an electronically braked bicycle ergometer using the Godfrey protocol. The peak work capacity (Wzirve) measurement will be expressed as a percentage of normal values.
Endothelial dysfunction
Time frame: Endothelial dysfunction assessment will be performed on the first day
Endothelial dysfunction will be determined by intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), E-selectin, Vascular endothelial growth factor (VEGF), Endothelin-1 (ET-1). Blood samples will be collected.
Arterial stiffness
Time frame: Arterial stiffness assessment will be performed on the first day
Arterial stiffness, oscillometric pulse wave velocity (PWV) (m s - 1) and augmentation index (AI@75) (%) will be evaluated by recorded brachial pulse waves with automatically with the oscillometric device.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
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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.
Deniz Inal-Ince, PhD study director
Hacettepe University
Senem Simsek, MSc principal investigator
Hacettepe University
Elmas Ebru Gunes-Yalcin, PhD principal investigator
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, 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 6 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal exercise capacity (time frame: Maximal exercise test will be performed on the first day). The study lists 3 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 6 Dec 2023.