COPD - Chronic Obstructive Pulmonary DiseaseNCT06974448
Hemodynamic Responses and Brain Activity During Dual Tasks in COPD Patients Versus Healthy Individuals
An observational study of COPD - Chronic Obstructive Pulmonary Disease and Healty Controls, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD - Chronic Obstructive Pulmonary Disease, Healty Controls
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 9 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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).
Who may be able to join
- 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
- Being between the ages of 40-65
- Being willing to participate in the study
Who cannot join
- Known alpha-1 anti-trypsin deficiency
- Presence of ischemic heart disease, uncontrolled hypertension, and diabetes mellitus
- Presence of obstructive sleep apnea syndrome
- Untreated tumors
- Known history of dementia
- Existing musculoskeletal, neuromuscular, or neurological diseases that may prevent participation in the tests
Show all 9Show fewer
- Not being willing to participate in the study
- Having a known chronic health problem
- Not being willing to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, 06000
About this study
Official title: Comparison of Frontal Hemodynamic Responses and Electrical Brain Activity During Dual Tasks in COPD Patients Versus Healthy Individuals
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.
Read the detailed description
This study aims to compare frontal hemodynamic responses and electrical brain activity to a dual task in individuals with COPD and healthy individuals and to investigate the relationship between frontal hemodynamic response and electrical brain activity and exercise capacity, arterial stiffness, balance, depression, anxiety, or quality of life.
The required sample size for the project was calculated as 28 individuals, 14 each for the COPD and control groups (G*Power Version 3.1.9.4, Franz Faul, Universitat Kiel, Germany), with a statistical significance of 94% test power and 0.05 error level for a difference of 3.33 points and 2.59 standard deviation (effect size 1.455) in the Mini-Mental State Examination score assessing cognitive function between the COPD and control groups. Considering a 10% dropout rate for each group, a total of 32 individuals, 16 in each group, will be included in the study.
Exercise tests will be performed with at least one day of rest breaks.
- st Session
- Patient file information will be recorded.
- A respiratory function test will be performed.
- MoCA and MMDT tests will be performed to evaluate general cognitive status.
- 6DWT tests will be performed. Muscle oxygenation will be measured during the test.
- An SGRQ questionnaire will be administered to the COPD Group.
- NHP questionnaire will be performed.
- nd Session
- Arterial stiffness measurement will be performed.
- TUG test will be performed.
- The HAD scale will be applied
- Cardiopulmonary exercise capacity will be evaluated. Muscle oxygenation will be measured during the test.
- rd Session
- Task-specific cognitive tests, Stroop tests, and N-back tests will be performed. fNIRS and EEG measurements will be performed during the Stroop and N-back tests.
- fNIRS and EEG measurements will be made during single and dual tasks.
Data Collection: The researchers will collect data on frontal hemodynamic responses, electrical brain activity, exercise capacity, arterial stiffness, and balance parameters through tests. Data on dyspnea, depression, anxiety, and quality of life measurements will be collected through scales applied during face-to-face interviews.
Data Analysis: Statistical analysis of the data obtained from all volunteers included in the study will be performed using the IBM SPSS 24.0 (SPSS Inc, Chicago, USA) program. Descriptive statistics will be calculated. The conformity of the variables to normal distribution will be evaluated using visual (histogram and probability graphs) and analytical methods (Kolmogorov-Smirnov/Shapiro-Wilk tests). In comparisons between groups, Student t-test will be used when parametric test assumptions are met, and Mann Whitney U test will be used when parametric test assumptions are not met. Chi-square test will be used for comparisons of categorical variables. Correlation between data that are normally distributed will be analyzed using Pearson correlation, and those that are not normally distributed will be analyzed using Spearman correlation. The error probability will be accepted as p<0.05.
- Keywords
- COPD - Chronic Obstructive Pulmonary Disease, dual task, cognitive function, electroencephalogram, Functional Near-Infrared Spectroscopy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD Group | Not described | |
| Control Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
Evaluation of hemodynamic responses in brain oxygenation
Functional Near Infrared Spectroscopy (fNIRS) will evaluate hemodynamic responses in brain oxygenation. FNIRS examinations measure hemodynamic responses (oxyhemoglobin and deoxyhemoglobin) in brain oxygenation to be able to transmit physical activity. It is a non-invasive optical imaging technique that allows real-time assessment of brain capacity. This will be an economical, high-durability (Artinis, Brite, Netherlands) wired 27-channel dual-wave length (760 and 850 nm) continuous wave (CW-fNIRS) system. Measurement will be performed during the cognitive , single and dual tasks.
Measured: through study completion, an average of 1 year
Evaluation of Changes in Brain Electrical Activity-Electroencephalography (EEG)
EEG is a measurement of electrical activity in the brain that records the frequencies observed during normal brain activity. EEG signals will be collected using a 32-channel EEG device (Mobile EEG Enobio, Neuroelectrics, Barcelona, Spain), portable, wireless data acquisition system at a sample rate of 250 Hz. The EEG device will be synchronized using e-PRIME (Physiology Software Tools. Brain waves are divided into delta (0-4 Hz), theta (4-8 Hz), alpha (8-12 Hz), low beta (12-16 Hz), high beta (16-25 Hz) and gamma (25-50 Hz) waves.The constituent factors of cognitive load will be measured separately in terms of the degree of activation of brain waves according to frequency. Measurement will be performed during the cognitive, single and dual tasks.
Measured: through study completion, an average of 1 year
Secondary outcomes (16)
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.
Measured: baseline
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.
Measured: baseline
Forced expiratory volume in one second
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second will be recorded.
Measured: through study completion, an average of 1 year
Forced vital capacity
Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.
Measured: through study completion, an average of 1 year
Forced expiratory volume in one second/forced vital capacity ratio
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second/forced vital capacity ratio will be recorded.
Measured: through study completion, an average of 1 year
Forced mid-expiratory flow (FEF25-75)
Pulmonary function test using a spirometer will be performed. Forced mid-expiratory flow (FEF25-75) will be recorded.
Measured: through study completion, an average of 1 year
Peak expiratory flow
Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.
Measured: through study completion, an average of 1 year
Evaluation of Dyspnea
Dyspnea will be evaluated with the Modified Medical Research Council dyspnea scale (MMRC). The MMRC evaluates patients' shortness of breath during a specific situation such as walking, climbing a hill or stairs. The scale is read aloud to patients and they are asked to mark the most appropriate option. The MMRC is a categorical scale used to describe individuals' dyspnea levels, with five statements ranging from 0 to 4 points, where the most appropriate statement regarding shortness of breath is selected. Higher scores indicate greater dyspnea severity.
Measured: through study completion, an average of 1 year
Functional Capacity Assessment
The 6-Minute Walk Test (6MWT) will be performed to assess functional capacity. For the 6MWT, individuals are asked to walk in a 30-meter corridor at the maximum speed they can walk without running. The test will be repeated twice at a 30-minute interval, and the distance covered at the end of the second test will be recorded in meters.
Measured: through study completion, an average of 1 year
Assessment of Maximal Exercise Capacity
Maximal exercise capacity will be determined by cardiopulmonary exercise testing (CPET). The protocol will be performed on a bicycle ergometer (Lode Corival, Groningen, Netherlands) in accordance with the European Respiratory Society's criteria. Cardiopulmonary responses and effort perceptions will be recorded.
Measured: through study completion, an average of 1 year
Evaluation of muscle oxygenation (SmO2) levels
During CPET and 6MWT, muscle oxygenation (SmO2) levels will also be measured. SmO2 level will be assessed with a wearable muscle oxygenation measurement device (Moxy, Fortiori Design LLC, Minnesota, USA) that measures local oxygen saturation in muscle capillaries. The device will be placed on the quadriceps muscle. The SmO2 level will be measured as a percentage, and the difference between the starting and ending percentages of the test will be recorded as a percentage.
Measured: through study completion, an average of 1 year
Arterial Stiffness Assessment
Arterial stiffness will be assessed with a portable measuring device (Tel-O-Graph BT, IEMGmbh, Aachen, Germany). Measurement will be performed in a quiet room after 12 hours of fasting in the morning, in a sitting position, with the patient resting for 15 minutes. Measurements will be performed three times at five-minute intervals.
Measured: through study completion, an average of 1 year
Functional Balance Assessment
The Timed Up Go Test (TUG) will be performed for functional balance assessment. In the TUG test, the participant is asked to get up from the chair without support, walk three meters, and then return to the chair without support. At the end of the test, the number of seconds it took the individual to complete the test will be recorded. The test will be performed twice, and the best score obtained from the two attempts will be recorded.
Measured: through study completion, an average of 1 year
Assessment of Anxiety and Depression Levels
The Hospital Anxiety and Depression Scale (HAD) will be used to assess anxiety and depression levels. HAD scale has been used in many studies on COPD. The total score ranges from 0 to 21 points, with scores <14 considered "normal." The scale's validity and reliability study was conducted, and the Turkish population-adapted form will be used.
Measured: through study completion, an average of 1 year
St. George's Respiratory Questionnaire (SGRQ)
St. George's Respiratory Questionnaire (SGRQ) will be used to assess disease-specific quality of life. The "symptoms" section (29 items) includes items related to symptom level, sputum production, cough frequency, breathlessness, wheezing or frequency and duration of wheezing attacks. The "Activity" section (9 items) evaluates physical activities that are restricted due to shortness of breath or that cause shortness of breath. The final section, the "Impact" section (38 items), evaluates factors such as panic, health checks, medication requirements and side effects, work, daily life effects and expectations for health. Each section is scored separately between 0-100 points. A "0 point" indicates that there is no impairment in quality of life.A validity and reliability study of the questionnaire was conducted, and an adapted form for the Turkish population will be used. The scale will be applied only to the COPD Group.
Measured: through study completion, an average of 1 year
Nottingham Health Profile (NHP)
The Nottingham Health Profile (NHP) will assess general quality of life. The NHP is a general quality of life scale developed to measure perceived health problems and the extent to which these problems affect normal daily activities. The questionnaire, which consists of a total of 38 items, evaluates six different parameters related to health status. These parameters are physical activity (8 items), emotional reactions (9 items), energy (3 items), social isolation (5 items), pain (8 items) and sleep (5 items). Each subparameter is scored between 0-100. A higher score indicates a worsening health status.The scale's validity and reliability study was conducted, and the Turkish population's adapted form will be used.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start15 May 2025 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion9 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for COPD - Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melike Meşe Buran, Hacettepe University
- Investigators
- Melike Mese- Buran, Msc, PT., Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974448
- Sponsor's protocol ID
- SBA 24/860
- Status last verified
- May 2025
- First submitted
- 3 Jan 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kucukdeveci AA, McKenna SP, Kutlay S, Gursel Y, Whalley D, Arasil T. The development and psychometric assessment of the Turkish version of the Nottingham Health Profile. Int J Rehabil Res. 2000 Mar;23(1):31-8. doi: 10.1097/00004356-200023010-00004.
PubMed 10826123Polatli M, Yorgancioglu A, Aydemir O, Yilmaz Demirci N, Kirkil G, Atis Nayci S, Kokturk N, Uysal A, Akdemir SE, Ozgur ES, Gunakan G. [Validity and reliability of Turkish version of St. George's respiratory questionnaire]. Tuberk Toraks. 2013;61(2):81-7. doi: 10.5578/tt.5404. Turkish.
PubMed 23875584Zhang L, Sun J, Sun B, Luo Q, Gong H. Studying hemispheric lateralization during a Stroop task through near-infrared spectroscopy-based connectivity. J Biomed Opt. 2014 May;19(5):57012. doi: 10.1117/1.JBO.19.5.057012.
PubMed 24862561Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
PubMed 15817019Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.
PubMed 12794644Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
PubMed 25359355Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999 Jan;159(1):179-87. doi: 10.1164/ajrccm.159.1.9712108.
PubMed 9872837Kaygusuz MH, Oral Tapan O, Tapan U, Genc S. Balance impairment and cognitive dysfunction in patients with chronic obstructive pulmonary disease under 65 years. Clin Respir J. 2022 Mar;16(3):200-207. doi: 10.1111/crj.13469. Epub 2022 Jan 26.
PubMed 35081270Alvarez-Bueno C, Cunha PG, Martinez-Vizcaino V, Pozuelo-Carrascosa DP, Visier-Alfonso ME, Jimenez-Lopez E, Cavero-Redondo I. Arterial Stiffness and Cognition Among Adults: A Systematic Review and Meta-Analysis of Observational and Longitudinal Studies. J Am Heart Assoc. 2020 Mar 3;9(5):e014621. doi: 10.1161/JAHA.119.014621. Epub 2020 Feb 28.
PubMed 32106748Li R, Yang D, Fang F, Hong KS, Reiss AL, Zhang Y. Concurrent fNIRS and EEG for Brain Function Investigation: A Systematic, Methodology-Focused Review. Sensors (Basel). 2022 Aug 5;22(15):5865. doi: 10.3390/s22155865.
PubMed 35957421Reijnders T, Troosters T, Janssens W, Gosselink R, Langer D, Davenport PW, von Leupoldt A. Brain Activations to Dyspnea in Patients With COPD. Front Physiol. 2020 Jan 24;11:7. doi: 10.3389/fphys.2020.00007. eCollection 2020.
PubMed 32038311Hassan SA, Bonetti LV, Kasawara KT, Beal DS, Rozenberg D, Reid WD. Decreased automaticity contributes to dual task decrements in older compared to younger adults. Eur J Appl Physiol. 2022 Apr;122(4):965-974. doi: 10.1007/s00421-022-04891-w. Epub 2022 Jan 27.
PubMed 35084541Hassan SA, Campos MA, Kasawara KT, Bonetti LV, Patterson KK, Beal DS, Fregonezi GAF, Stanbrook MB, Reid WD. Changes in Oxyhemoglobin Concentration in the Prefrontal Cortex during Cognitive-Motor Dual Tasks in People with Chronic Obstructive Pulmonary Disease. COPD. 2020 Jun;17(3):289-296. doi: 10.1080/15412555.2020.1767561. Epub 2020 May 22.
PubMed 32441147Gore S, Blackwood J, Ziccardi T. Associations Between Cognitive Function, Balance, and Gait Speed in Community-Dwelling Older Adults with COPD. J Geriatr Phys Ther. 2023 Jan-Mar 01;46(1):46-52. doi: 10.1519/JPT.0000000000000323. Epub 2021 Jul 29.
PubMed 34334706Wen XH, Li Y, Han D, Sun L, Ren PX, Ren D. The relationship between cognitive function and arterial partial pressure O2 in patients with COPD: A meta-analysis. Medicine (Baltimore). 2018 Jan;97(4):e9599. doi: 10.1097/MD.0000000000009599.
PubMed 29369175
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Frontal Hemodynamic Responses and Electrical Brain Activity During Dual Tasks in COPD Patients Versus Healthy Individuals
- ClinicalTrials.gov ID
- NCT06974448
- Acronym / sponsor ID
- SBA 24/860
- Keywords
- COPD - Chronic Obstructive Pulmonary Disease, dual task, cognitive function, electroencephalogram, Functional Near-Infrared Spectroscopy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 9 Oct 2026 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to compare frontal hemodynamic responses and electrical brain activity to a dual task in individuals with COPD and healthy individuals and to investigate the relationship between frontal hemodynamic response and electrical brain activity and exercise capacity, arterial stiffness, balance, depression, anxiety, or quality of life.
The required sample size for the project was calculated as 28 individuals, 14 each for the COPD and control groups (G*Power Version 3.1.9.4, Franz Faul, Universitat Kiel, Germany), with a statistical significance of 94% test power and 0.05 error level for a difference of 3.33 points and 2.59 standard deviation (effect size 1.455) in the Mini-Mental State Examination score assessing cognitive function between the COPD and control groups. Considering a 10% dropout rate for each group, a total of 32 individuals, 16 in each group, will be included in the study.
Exercise tests will be performed with at least one day of rest breaks.
- st Session
- Patient file information will be recorded.
- A respiratory function test will be performed.
- MoCA and MMDT tests will be performed to evaluate general cognitive status.
- 6DWT tests will be performed. Muscle oxygenation will be measured during the test.
- An SGRQ questionnaire will be administered to the COPD Group.
- NHP questionnaire will be performed.
- nd Session
- Arterial stiffness measurement will be performed.
- TUG test will be performed.
- The HAD scale will be applied
- Cardiopulmonary exercise capacity will be evaluated. Muscle oxygenation will be measured during the test.
- rd Session
- Task-specific cognitive tests, Stroop tests, and N-back tests will be performed. fNIRS and EEG measurements will be performed during the Stroop and N-back tests.
- fNIRS and EEG measurements will be made during single and dual tasks.
Data Collection: The researchers will collect data on frontal hemodynamic responses, electrical brain activity, exercise capacity, arterial stiffness, and balance parameters through tests. Data on dyspnea, depression, anxiety, and quality of life measurements will be collected through scales applied during face-to-face interviews.
Data Analysis: Statistical analysis of the data obtained from all volunteers included in the study will be performed using the IBM SPSS 24.0 (SPSS Inc, Chicago, USA) program. Descriptive statistics will be calculated. The conformity of the variables to normal distribution will be evaluated using visual (histogram and probability graphs) and analytical methods (Kolmogorov-Smirnov/Shapiro-Wilk tests). In comparisons between groups, Student t-test will be used when parametric test assumptions are met, and Mann Whitney U test will be used when parametric test assumptions are not met. Chi-square test will be used for comparisons of categorical variables. Correlation between data that are normally distributed will be analyzed using Pearson correlation, and those that are not normally distributed will be analyzed using Spearman correlation. The error probability will be accepted as p<0.05.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD Group | – | – |
| Control Group | – | – |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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).
Key inclusion criteria (6 listed)
- 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
- Being between the ages of 40-65
Key exclusion criteria (9 listed)
- Known alpha-1 anti-trypsin deficiency
- Presence of ischemic heart disease, uncontrolled hypertension, and diabetes mellitus
- Presence of obstructive sleep apnea syndrome
- Untreated tumors
- Known history of dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mini-Mental State Examination (MMST)
Time frame: through study completion, an average of 1 year
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
Montreal Cognitive Assessment Scale (MoCA)
Time frame: through study completion, an average of 1 year
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.
Stroop test
Time frame: through study completion, an average of 1 year
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.
N back test
Time frame: through study completion, an average of 1 year
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.
Evaluation of hemodynamic responses in brain oxygenation
Time frame: through study completion, an average of 1 year
Functional Near Infrared Spectroscopy (fNIRS) will evaluate hemodynamic responses in brain oxygenation. FNIRS examinations measure hemodynamic responses (oxyhemoglobin and deoxyhemoglobin) in brain oxygenation to be able to transmit physical activity. It is a non-invasive optical imaging technique that allows real-time assessment of brain capacity. This will be an economical, high-durability (Artinis, Brite, Netherlands) wired 27-channel dual-wave length (760 and 850 nm) continuous wave (CW-fNIRS) system. Measurement will be performed during the cognitive , single and dual tasks.
Evaluation of Changes in Brain Electrical Activity-Electroencephalography (EEG)
Time frame: through study completion, an average of 1 year
EEG is a measurement of electrical activity in the brain that records the frequencies observed during normal brain activity. EEG signals will be collected using a 32-channel EEG device (Mobile EEG Enobio, Neuroelectrics, Barcelona, Spain), portable, wireless data acquisition system at a sample rate of 250 Hz. The EEG device will be synchronized using e-PRIME (Physiology Software Tools. Brain waves are divided into delta (0-4 Hz), theta (4-8 Hz), alpha (8-12 Hz), low beta (12-16 Hz), high beta (16-25 Hz) and gamma (25-50 Hz) waves.The constituent factors of cognitive load will be measured separately in terms of the degree of activation of brain waves according to frequency. Measurement will be performed during the cognitive, single and dual tasks.
16 secondary outcomes
Demographic Assessment
Time frame: baseline
Charlson Comorbidity Index
Time frame: baseline
Forced expiratory volume in one second
Time frame: through study completion, an average of 1 year
Forced vital capacity
Time frame: through study completion, an average of 1 year
Forced expiratory volume in one second/forced vital capacity ratio
Time frame: through study completion, an average of 1 year
Forced mid-expiratory flow (FEF25-75)
Time frame: through study completion, an average of 1 year
Peak expiratory flow
Time frame: through study completion, an average of 1 year
Evaluation of Dyspnea
Time frame: through study completion, an average of 1 year
Functional Capacity Assessment
Time frame: through study completion, an average of 1 year
Assessment of Maximal Exercise Capacity
Time frame: through study completion, an average of 1 year
Evaluation of muscle oxygenation (SmO2) levels
Time frame: through study completion, an average of 1 year
Arterial Stiffness Assessment
Time frame: through study completion, an average of 1 year
Functional Balance Assessment
Time frame: through study completion, an average of 1 year
Assessment of Anxiety and Depression Levels
Time frame: through study completion, an average of 1 year
St. George's Respiratory Questionnaire (SGRQ)
Time frame: through study completion, an average of 1 year
Nottingham Health Profile (NHP)
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Background: PubMed 10826123Kucukdeveci AA, McKenna SP, Kutlay S, Gursel Y, Whalley D, Arasil T. The development and psychometric assessment of the Turkish version of the Nottingham Health Profile. Int J Rehabil Res. 2000 Mar;23(1):31-8. doi: 10.1097/00004356-200023010-00004.
- Background: PubMed 23875584Polatli M, Yorgancioglu A, Aydemir O, Yilmaz Demirci N, Kirkil G, Atis Nayci S, Kokturk N, Uysal A, Akdemir SE, Ozgur ES, Gunakan G. [Validity and reliability of Turkish version of St. George's respiratory questionnaire]. Tuberk Toraks. 2013;61(2):81-7. doi: 10.5578/tt.5404. Turkish.
- Background: PubMed 24862561Zhang L, Sun J, Sun B, Luo Q, Gong H. Studying hemispheric lateralization during a Stroop task through near-infrared spectroscopy-based connectivity. J Biomed Opt. 2014 May;19(5):57012. doi: 10.1117/1.JBO.19.5.057012.
- Background: PubMed 15817019Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
- Background: PubMed 12794644Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.
- Background: PubMed 25359355Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
- Background: PubMed 9872837Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999 Jan;159(1):179-87. doi: 10.1164/ajrccm.159.1.9712108.
- Background: PubMed 35081270Kaygusuz MH, Oral Tapan O, Tapan U, Genc S. Balance impairment and cognitive dysfunction in patients with chronic obstructive pulmonary disease under 65 years. Clin Respir J. 2022 Mar;16(3):200-207. doi: 10.1111/crj.13469. Epub 2022 Jan 26.
- Background: PubMed 32106748Alvarez-Bueno C, Cunha PG, Martinez-Vizcaino V, Pozuelo-Carrascosa DP, Visier-Alfonso ME, Jimenez-Lopez E, Cavero-Redondo I. Arterial Stiffness and Cognition Among Adults: A Systematic Review and Meta-Analysis of Observational and Longitudinal Studies. J Am Heart Assoc. 2020 Mar 3;9(5):e014621. doi: 10.1161/JAHA.119.014621. Epub 2020 Feb 28.
- Background: PubMed 35957421Li R, Yang D, Fang F, Hong KS, Reiss AL, Zhang Y. Concurrent fNIRS and EEG for Brain Function Investigation: A Systematic, Methodology-Focused Review. Sensors (Basel). 2022 Aug 5;22(15):5865. doi: 10.3390/s22155865.
- Background: PubMed 32038311Reijnders T, Troosters T, Janssens W, Gosselink R, Langer D, Davenport PW, von Leupoldt A. Brain Activations to Dyspnea in Patients With COPD. Front Physiol. 2020 Jan 24;11:7. doi: 10.3389/fphys.2020.00007. eCollection 2020.
- Background: PubMed 35084541Hassan SA, Bonetti LV, Kasawara KT, Beal DS, Rozenberg D, Reid WD. Decreased automaticity contributes to dual task decrements in older compared to younger adults. Eur J Appl Physiol. 2022 Apr;122(4):965-974. doi: 10.1007/s00421-022-04891-w. Epub 2022 Jan 27.
- GLOBAL STRATEGY FOR PREVENTION, DIAGNOSIS AND MANAGEMENT OF COPD: 2023 ReportLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melike Mese- Buran, Msc, PT. principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD - Chronic Obstructive Pulmonary Disease and Healty Controls, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melike Mese Buran, Msc, PT. (+90 5070045210, melikemese@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (MMST) (time frame: through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06974448, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.