Clinical trial NCT04259983: Investigation of Relationship Between Vascular Functions, Exercise Capacity, and Respiratory Functions in CF
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: Endothelial Dysfunction
Arterial Stiffness
Exercise Capacity
Respiratory Functions
Children
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximal exercise capacity
timeFrame: Maximal exercise test will be performed on the first day
measure: Endothelial dysfunction
timeFrame: Endothelial dysfunction assessment will be performed on the first day
measure: Arterial stiffness
timeFrame: Arterial stiffness assessment will be performed on the first day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Study officials:
affiliation: Hacettepe University
name: Deniz Inal-Ince, PhD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Senem Simsek, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Elmas Ebru Gunes-Yalcin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Murat Timur Budak, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Nagehan Emiralioglu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Aslihan Cakmak, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Yasemin Kartal, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Suna Sabuncuoğlu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Meltem Akgül Erdal, MSc
role: PRINCIPAL_INVESTIGATOR
References: