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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04259983
• Other study ID #: GO19/1156
• Status: Completed
• Start date: April 11, 2022
• Est. completion date: May 2, 2023

Study information

• Verified date: November 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2, 2023
• Est. primary completion date: December 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• Maximal exercise test
The maximal exercise test will be performed on an electronically braked bicycle ergometer.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Hacettepe University, Faculty of Physical Therapy and Rehabilitation	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Maximal exercise test will be performed on the first day
Primary	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.	Endothelial dysfunction assessment will be performed on the first day
Primary	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.	Arterial stiffness assessment will be performed on the first day