Assessment of Cognitive Function and Exercise Capacity in Cystic Fibrosis

Hacettepe University48 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cystic Fibrosis

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

Exercise capacity

Exercise capacity is assessed using the 6-minute walk test (6MWT). The 6MWT is performed according to the criteria of the American Thoracic Society.

Time frame: 6 minutes

Arterial Stiffness Assessment

Arterial stiffness is determined using a oscillometric cuff device (Tel-O-Graph BT, I.E.M., Stolberg, Germany). Pulse wave velocity (PWV) and augmentation index (AIx) are measured by brachial pulse waves.

Time frame: 20 minutes

Cognitive Assessment- MoCA

Cognitive function is measured using the Montreal Cognitive Assessment (MoCA) test. The MoCA test is a questionnaire developed to evaluate different cognitive functions and mild cognitive impairment. The maximum score that an individual can obtain from the test is 30, and a score of 26 above is considered as mild cognitive impairment.

Time frame: 10 minutes

Cognitive Assessment-Mini Mental Test

Cognitive function is measured using the Mini Mental Test. A higher score indicates better cognitive function. The maximum score that an individual can obtain from the test is 30, and a score of 23 and above is considered as cognitive impairment.

Time frame: 10 minutes

Muscle Oxygenation Assessment

Muscle oxygenation (SmO2) is assessed using a measuring and monitoring device (Moxy Fortiori Desing LLC, Minnesota, USA).

Time frame: 10 minutes

Secondary Outcomes

Body Composition

Body fat is measured using skinfold thickness assessment.

Time frame: 5 minutes

Data from ClinicalTrials.gov

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Pulmonary Function Test (forced vital capacity (FVC))

Testing procedures is in accordance with the guidelines published by ATS/ERS. A portable spirometer is used for assessment. Pulmonary function testing assesses forced vital capacity (FVC).

Time frame: 10 minutes

Pulmonary Function Test (forced expiratory volume in the first second (FEV1))

Testing procedures is in accordance with the guidelines published by ATS/ERS. A portable spirometer is used for assessment. Pulmonary function testing assesses forced expiratory volume in the first second (FEV1).

Time frame: 10 minutes

Pulmonary Function Test (FEV1/FVC)

Testing procedures is in accordance with the guidelines published by ATS/ERS. A portable spirometer is used for assessment. Pulmonary function testing assesses FEV1/FVC.

Time frame: 10 minutes

Pulmonary Function Test (peak flow rate (PEF))

Testing procedures is in accordance with the guidelines published by ATS/ERS. A portable spirometer is used for assessment. Pulmonary function testing assesses peak flow rate (PEF).

Time frame: 10 minutes

Pulmonary Function Test (forced expiratory flow from 25-75% (FEF25-75%))

Time frame: 10 minutes

Respiratory Muscle Strength

Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) are measured using a mouth pressure measuring device with personal antibacterial and antiviral disposable filters.

Time frame: 10 minutes

Peripheral Muscle Strength

Knee extensor muscle strength is measured utilizing a portable device.

Time frame: 5 minutes

Anxiety and Depression

The Hospital Anxiety and Depression scale (HADS) is used to evaluate anxiety and depression. Higher scores correspond to more anxiety and depression symptoms.

Time frame: 5 minutes

Physical Activity Assessment

Physical activity levels is assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). The IPAQ requires respondents to estimate time spent in various levels of physical activity during the previous week. Scores for walking and moderate and vigorous activities are calculated as durations and frequencies multiplied by known metabolic equivalents per activity. The results for all activity-based items are summed for the total physical activity score. The participants were then categorized as inactive, minimally active and sufficiently active according to the IPAQ categorical classification.

Time frame: 5 minutes

Sleep Quality

Sleep quality is evaluated using the Pittsburgh Sleep Quality Index (PSQI). The scale total score is between 0 and 21. A total score of 5 and above indicates poor sleep quality.

Time frame: 5 minutes

Disease Specific Quality of Life

Disease-specific quality of life is evaluated using the Cystic Fibrosis Questionnaire-Revised (CFQ-R). The CFQ-R includes 50 items across 12 domains. Each domain is standardized on a 0-100 scale; higher scores indicate better quality of life.

Time frame: 8 minutes

General Health-Related Quality of Life

Health-related quality of life is assessed using the Nottingham Health Profile (NHP). It is a general QOL questionnaire designed to measure perceived health problems and the extent to which these problems affect normal daily activities. It consists of 38 items in six dimensions (energy level, pain, physical mobility, emotional reactions, social isolation, and sleep). The total score for each section is 0-100. High scores indicate worse quality of life.

Time frame: 5 minutes