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Investigation of Relationship Between Vascular Functions, Exercise Capacity, and Respiratory Functions in CF

NCT ID: NCT04259983

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-11

Study Completion Date

2023-05-02

Brief Summary

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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

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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

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Cystic Fibrosis

Keywords

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Endothelial Dysfunction Arterial Stiffness Exercise Capacity Respiratory Functions Children

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Maximal exercise test

Intervention Type OTHER

The maximal exercise test will be performed on an electronically braked bicycle ergometer.

Endothelial dysfunction assessment

Intervention Type OTHER

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 assessment

Intervention Type OTHER

Arterial stiffness, oscillometric pulse wave velocity (PWV) and augmentation index will be evaluated by recorded brachial pulse waves with automatically with the oscillometric device.

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.

Maximal exercise test

Intervention Type OTHER

The maximal exercise test will be performed on an electronically braked bicycle ergometer.

Endothelial dysfunction assessment

Intervention Type OTHER

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 assessment

Intervention Type OTHER

Arterial stiffness, oscillometric pulse wave velocity (PWV) and augmentation index will be evaluated by recorded brachial pulse waves with automatically with the oscillometric device.

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.

Maximal exercise test

Intervention Type OTHER

The maximal exercise test will be performed on an electronically braked bicycle ergometer.

Endothelial dysfunction assessment

Intervention Type OTHER

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 assessment

Intervention Type OTHER

Arterial stiffness, oscillometric pulse wave velocity (PWV) and augmentation index will be evaluated by recorded brachial pulse waves with automatically with the oscillometric device.

Interventions

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Maximal exercise test

The maximal exercise test will be performed on an electronically braked bicycle ergometer.

Intervention Type OTHER

Endothelial dysfunction assessment

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.

Intervention Type OTHER

Arterial stiffness assessment

Arterial stiffness, oscillometric pulse wave velocity (PWV) and augmentation index will be evaluated by recorded brachial pulse waves with automatically with the oscillometric device.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Cardiovascular disease
* Hypertension
* Diabetes
* Pulmonary hypertension
* Smoking
* Resting oxygen saturation (SpO2) \<92%
* 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
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Senem Simsek

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deniz Inal-Ince, PhD

Role: STUDY_DIRECTOR

Hacettepe University

Senem Simsek, MSc

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Elmas Ebru Gunes-Yalcin, PhD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Murat Timur Budak, PhD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Nagehan Emiralioglu, PhD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Aslihan Cakmak, MSc

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Yasemin Kartal, MSc

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Suna Sabuncuoğlu, PhD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Meltem Akgül Erdal, MSc

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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GO19/1156

Identifier Type: -

Identifier Source: org_study_id