Clinical trial NCT06175182: Assessment of Cognitive Function and Exercise Capacity in Cystic Fibrosis
Official title: A Comparison of Exercise Capacity, Arterial Stiffness, and Cognitive Function Between Adults With Cystic Fibrosis and Healthy Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
exercise test
cognitive impairment
arterial stiffness
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 24 patients with cystic fibrosis will be included in patients group and 24 healthy individuals will be included in control group.

Brief summary: No studies in the literature have investigated the simultaneous effects of cognitive function, exercise capacity and arterial stiffness in adult patients with CF. The study aims to compare the cognitive function, exercise capacity, exercise muscle oxygenation, and arterial stiffness of adult patients with CF and healthy subjects.

Detailed description: Cystic fibrosis (CF) affects other body systems as well as the respiratory system. Patients with CF seem to have reduced exercise capacity, which is a major contributor to mortality rates. Changes in lung function, ventilatory dysfunction, and respiratory muscle function potentially contribute to exercise intolerance in CF. Both children and adults with CF exhibit neurocognitive dysfunction. Arterial stiffness is a predictor of cardiovascular events, including myocardial infarction, heart failure, and mortality. Individuals with CF exhibit an increase in arterial stiffness. However, no studies in the literature have investigated cognitive function, exercise capacity, and arterial stiffness coexistence in adult CF patients. The study aims to compare the cognitive function, exercise capacity, exercise muscle oxygenation and arterial stiffness in adult patients with CF and healthy subjects. Additionally, it will determine the relationship between cognitive function and arterial stiffness with exercise capacity and muscle oxygenation during exercise in adult patients with CF.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with cystic fibrosis
* Being 18 years old and older
* Clinically stable condition
* Able to cooperate with the tests performed
* Volunteered to participate in the study

For the control group:

* Being 18 years old and older
* Volunteered to participate in the study

Exclusion Criteria:

* History of hospitalization or exacerbation in the last month.
* Chronic respiratory failure and long-term use of oxygen therapy
* Using noninvasive mechanical ventilator therapy
* Indication for lung transplantation
* Who had a lung transplant
* Forced expiratory volume in the first second (FEV1) value 30% and below
* CF-related diabetes
* Chronic liver disease
* Allergic bronchopulmonary aspergillosis
* Systemic steroid use
* History of diagnosed orthopedic or musculoskeletal problems affecting mobility
* Cardiovascular instability
* Serious psychiatric illness

For the control group:

* Known chronic or systemic disease
* Who did not volunteer to participate in the study

Primary outcomes:
measure: Exercise capacity
timeFrame: 6 minutes
measure: Arterial Stiffness Assessment
timeFrame: 20 minutes
measure: Cognitive Assessment- MoCA
timeFrame: 10 minutes
measure: Cognitive Assessment-Mini Mental Test
timeFrame: 10 minutes
measure: Muscle Oxygenation Assessment
timeFrame: 10 minutes
Secondary outcomes:
measure: Body Composition
timeFrame: 5 minutes
measure: Pulmonary Function Test (forced vital capacity (FVC))
timeFrame: 10 minutes
measure: Pulmonary Function Test (forced expiratory volume in the first second (FEV1))
timeFrame: 10 minutes
measure: Pulmonary Function Test (FEV1/FVC)
timeFrame: 10 minutes
measure: Pulmonary Function Test (peak flow rate (PEF))
timeFrame: 10 minutes
measure: Pulmonary Function Test (forced expiratory flow from 25-75% (FEF25-75%))
timeFrame: 10 minutes
measure: Respiratory Muscle Strength
timeFrame: 10 minutes
measure: Peripheral Muscle Strength
timeFrame: 5 minutes
measure: Anxiety and Depression
timeFrame: 5 minutes
measure: Physical Activity Assessment
timeFrame: 5 minutes
measure: Sleep Quality
timeFrame: 5 minutes
measure: Disease Specific Quality of Life
timeFrame: 8 minutes
measure: General Health-Related Quality of Life
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Deniz Inal-Ince, PhD
role: PRINCIPAL_INVESTIGATOR
References: