Assessment of Cognitive Function and Exercise Capacity in Cystic Fibrosis
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT06175182
- Lead Sponsor
- Hacettepe University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Exercise capacity 6 minutes Exercise capacity is assessed using the 6-minute walk test (6MWT). The 6MWT is performed according to the criteria of the American Thoracic Society.
Muscle Oxygenation Assessment 10 minutes Muscle oxygenation (SmO2) is assessed using a measuring and monitoring device (Moxy Fortiori Desing LLC, Minnesota, USA).
Cognitive Assessment- MoCA 10 minutes 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.
Arterial Stiffness Assessment 20 minutes 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.
Cognitive Assessment-Mini Mental Test 10 minutes 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.
- Secondary Outcome Measures
Name Time Method Respiratory Muscle Strength 10 minutes Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) are measured using a mouth pressure measuring device with personal antibacterial and antiviral disposable filters.
Peripheral Muscle Strength 5 minutes Knee extensor muscle strength is measured utilizing a portable device.
Body Composition 5 minutes Body fat is measured using skinfold thickness assessment.
Physical Activity Assessment 5 minutes 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.
Sleep Quality 5 minutes 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.
Pulmonary Function Test (forced expiratory volume in the first second (FEV1)) 10 minutes 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).
Pulmonary Function Test (peak flow rate (PEF)) 10 minutes 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).
Pulmonary Function Test (forced vital capacity (FVC)) 10 minutes 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).
Pulmonary Function Test (FEV1/FVC) 10 minutes 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.
Pulmonary Function Test (forced expiratory flow from 25-75% (FEF25-75%)) 10 minutes 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 flow from 25-75% (FEF25-75%).
Anxiety and Depression 5 minutes The Hospital Anxiety and Depression scale (HADS) is used to evaluate anxiety and depression. Higher scores correspond to more anxiety and depression symptoms.
General Health-Related Quality of Life 5 minutes 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.
Disease Specific Quality of Life 8 minutes 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.
Trial Locations
- Locations (1)
Hacettepe University
🇹🇷Ankara, Turkey