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

NCT04259983 | Completed

• 1 other identifier: GO19/1156
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Endothelial Dysfunction; Arterial Stiffness; Exercise Capacity; Respiratory Functions; Children

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

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.

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.

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.

Other: Maximal exercise test; Other: Endothelial dysfunction assessment; Other: Arterial stiffness assessment

Interventions

Maximal exercise test OTHER

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

Patients with CF with mild obstruction severity; Patients with CF with moderate obstruction severity; Patients with CF with normal obstruction severity

Endothelial dysfunction assessment 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.

Patients with CF with mild obstruction severity; Patients with CF with moderate obstruction severity; Patients with CF with normal obstruction severity

Arterial stiffness assessment 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; Patients with CF with moderate obstruction severity; Patients with CF with normal obstruction severity

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, Turkey (Türkiye)

Location

Biospecimen

Blood sample

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Deniz Inal-Ince, PhD

  Hacettepe University

  STUDY DIRECTOR

• Senem Simsek, MSc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Elmas Ebru Gunes-Yalcin, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Murat Timur Budak, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Nagehan Emiralioglu, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Aslihan Cakmak, MSc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Yasemin Kartal, MSc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Suna Sabuncuoğlu, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Meltem Akgül Erdal, MSc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: February 7, 2020
• Study Start: April 11, 2022
• Primary Completion: December 8, 2022
• Study Completion: May 2, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-11

Locations

TU (1)