Hemodynamic Responses and Brain Activity During Dual Tasks in COPD Patients Versus Healthy Individuals
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-65
SponsorHacettepe University
About this trial
Abstract
Cognitive dysfunction is joint in patients with chronic obstructive pulmonary disease (COPD).
In particular, there are effects in tasks that require attention, executive functions, and working memory related to the prefrontal cortex. These effects make it difficult to perform two tasks simultaneously and cause performance errors. The number of studies investigating the effects of cognitive impairments on dual-task performance in COPD is limited. In these studies, no tests were applied specifically for attention and working memory areas; therefore, the brain's neural activity was not investigated during these tests. Multimodal approaches are recommended for a comprehensive assessment of the functional activity of the brain. Multimodal approaches provide more accurate results than single-modality approaches. In the integrated electroencephalography (EEG)-functional near-infrared spectroscopy (fNIRS) approach, EEG provides adequate temporal resolution, while fNIRS offers better spatial resolution and is robust to noise. There is no study in COPD where simultaneous fNIRS-EEG measurements were made during both cognitive tests and dual tasks. In our study, the simultaneous measurement of frontal hemodynamic responses and electrical brain activity in both cognitive tests and dual-task conditions and the examination of the relationship between the results and arterial stiffness, balance, exercise capacity, anxiety, depression, and quality of life scores, which are reported to be related to cognitive function in COPD, constitute the original aspect of our study. The study will include 16 COPD and 16 healthy individuals. The same assessments will be made in both groups, and the results will be compared. General and task-specific cognitive tests, prefrontal cortex oxygenation (fNIRS), electrical brain activity (EEG), exercise capacity, muscle oxygenation, arterial stiffness, balance, respiratory function, dyspnea, depression, anxiety, and quality of life will be evaluated. As a result of this study is expected to determine the effects of cognitive function and dual-task on frontal hemodynamic responses and electrical brain activity in COPD.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Being diagnosed with COPD
Being between the ages of 40-65
Not having a history of exacerbations in the last 4 week
Being willing to participate in the study
Disqualifiers
Known alpha-1 anti-trypsin deficiency
Presence of ischemic heart disease, uncontrolled hypertension, and diabetes mellitus
Presence of obstructive sleep apnea syndrome
Untreated tumors
Trial population
Individuals who were followed up at Hacettepe University Chest Diseases Department due to COPD diagnosis and referred to Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit for physiotherapy and rehabilitation (COPD Group). Individuals with COPD (COPD Group) and healthy individuals who were matched in terms of age and gender and volunteered to participate in the study (relatives of the researchers, relatives of the patients, and hospital staff) (Control Group).
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
32 Participants
are grouped into 2 trial groupsGroup A: COPD Group
Group B: Control Group
Trial outcomes
Primary outcomes
1
Mini-Mental State Examination (MMST)
The Mini-Mental State Examination (MMST) will be used for general cognitive status assessment. MMST consists of 11 items grouped under five main headings (execution, recording memory, attention and calculation, recall and language). The total score is obtained by adding the scores obtained by the patient from each item. It is evaluated out of a total of 30 points.The Turkish version of the test will be used
Time frame
through study completion, an average of 1 year2
Montreal Cognitive Assessment Scale (MoCA)
MoCA, the presence of cognitive impairment will be evaluated using the MoCA scale. The scale is scored between 0 and 30 points. The application time of the scale is approximately 10 minutes and includes six cognitive functions. The cognitive functions evaluated in the scale are memory, visual-spatial skills, executive functions, attention, concentration and working memory tasks, language and orientation. The Turkish version of the scale will be used.
Time frame
through study completion, an average of 1 year3
Stroop test
The Stroop test is a widely used test to evaluate executive functions of the frontal region, such as selective attention, information processing speed, cognitive flexibility, and the ability to resist interference. It is one of the tests considered the gold standard for measuring a person's attention. It is especially preferred to measure executive control in a situation that creates cognitive conflict. In the Stroop test, the person is expected to shift their attention to the color of the ink the word is written in, rather than the semantic meaning. When there is a conflict between visual information (the color of the ink the word is written in) and semantic information (the meaning of the word), the person's response is delayed or gives an incorrect answer.
Time frame
through study completion, an average of 1 year4
N back test
The N-back test has been used in both experimental and neuroimaging studies as a measure of working memory ability and has been called the gold standard technique for the assessment of working memory. The study will use a "0-back and 2-back task". During this test, the participant is expected to respond if the stimulus shown on the screen overlaps with the stimulus shown 'n' times before. Various letters were selected as stimuli. The visual stimulus appeared on the screen for 500 milliseconds (msec), with a 2000 msec waiting period between the two stimuli. All participants will be initially informed about the task, then given a practice test, and will proceed to the main test after at least three correct responses. No intervention will be made during the main test. In the evaluation of this test, the number of correct hits and false alarms will be determined according to the participant's responses, and correct hit and false alarm scores will be calculated using these data.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Demographic Assessment
The participants' age, gender, height, body weight, and smoking will be recorded. Clinical data will be recorded from the patients' file information, including COPD diagnosis period, risk factors, and COPD stage. The participants' accompanying diseases will be evaluated with the Charlson Comorbidity Index, developed to predict chronic diseases' effect on mortality and morbidity.
Time frame
baseline2
Charlson Comorbidity Index
Charlson Comorbidity Index is calculated by giving coronary artery disease, congestive heart failure, peripheral vascular diseases, cerebrovascular diseases, dementia, chronic lung disease, connective tissue disease, peptic ulcer disease, mild liver disease, diabetes "1 point", hemiplegia, moderate or severe kidney disease, diabetes causing end-organ damage, any tumor presence, leukemia, lymphoma "2 points", moderate or severe liver disease "3 points", metastatic solid tumor, AIDS "6 points". As the comorbidity score increases, the risk of mortality and morbidity increases in patients.
Time frame
baseline3
Forced expiratory volume in one second
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second will be recorded.
Time frame
through study completion, an average of 1 year4
Forced vital capacity
Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov
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