Hemodynamic Responses and Brain Activity During Dual Tasks in COPD Patients Versus Healthy Individuals
NCT06974448, Not yet recruiting, Hacettepe University
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Hemodynamic Responses and Brain Activity During Dual Tasks in COPD Patients Versus Healthy Individuals | ClinicalTrials.gov |
| NCT number | NCT06974448 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 32 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Hacettepe University | ClinicalTrials.gov |
| Conditions | COPD - Chronic Obstructive Pulmonary Disease, Healty Controls | ClinicalTrials.gov |
| First posted | 2025-05-16 | ClinicalTrials.gov |
| Last updated | 2025-05-16 | ClinicalTrials.gov |
Registered outcomes 22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Mini-Mental State Examination (MMST) | 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 | ClinicalTrials.gov |
| Primary | Montreal Cognitive Assessment Scale (MoCA) | 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. | ClinicalTrials.gov |
| Primary | Stroop test | 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. | ClinicalTrials.gov |
| Primary | N back test | 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. | ClinicalTrials.gov |
| Primary | Evaluation of hemodynamic responses in brain oxygenation | 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. | ClinicalTrials.gov |
| Primary | Evaluation of Changes in Brain Electrical Activity-Electroencephalography (EEG) | 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. | ClinicalTrials.gov |
| Secondary | Demographic Assessment | baseline | 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. | ClinicalTrials.gov |
| Secondary | Charlson Comorbidity Index | baseline | 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. | ClinicalTrials.gov |
| Secondary | Forced expiratory volume in one second | through study completion, an average of 1 year | Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second will be recorded. | ClinicalTrials.gov |
| Secondary | Forced vital capacity | through study completion, an average of 1 year | Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded. | ClinicalTrials.gov |
| Secondary | Forced expiratory volume in one second/forced vital capacity ratio | through study completion, an average of 1 year | Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second/forced vital capacity ratio will be recorded. | ClinicalTrials.gov |
| Secondary | Forced mid-expiratory flow (FEF25-75) | through study completion, an average of 1 year | Pulmonary function test using a spirometer will be performed. Forced mid-expiratory flow (FEF25-75) will be recorded. | ClinicalTrials.gov |
| Secondary | Peak expiratory flow | through study completion, an average of 1 year | Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded. | ClinicalTrials.gov |
| Secondary | Evaluation of Dyspnea | through study completion, an average of 1 year | 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. | ClinicalTrials.gov |
| Secondary | Functional Capacity Assessment | through study completion, an average of 1 year | 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. | ClinicalTrials.gov |
| Secondary | Assessment of Maximal Exercise Capacity | through study completion, an average of 1 year | 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. | ClinicalTrials.gov |
| Secondary | Evaluation of muscle oxygenation (SmO2) levels | through study completion, an average of 1 year | 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. | ClinicalTrials.gov |
| Secondary | Arterial Stiffness Assessment | through study completion, an average of 1 year | 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. | ClinicalTrials.gov |
| Secondary | Functional Balance Assessment | through study completion, an average of 1 year | 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. | ClinicalTrials.gov |
| Secondary | Assessment of Anxiety and Depression Levels | through study completion, an average of 1 year | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 16
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 9872837 | BACKGROUND | PubMed |
| 10826123 | BACKGROUND | PubMed |
| 12794644 | BACKGROUND | PubMed |
| 15817019 | BACKGROUND | PubMed |
| 23875584 | BACKGROUND | PubMed |
| 24862561 | BACKGROUND | PubMed |
| 25359355 | BACKGROUND | PubMed |
| 29369175 | BACKGROUND | PubMed |
| 32038311 | BACKGROUND | PubMed |
| 32106748 | BACKGROUND | PubMed |
| 32441147 | BACKGROUND | PubMed |
| 32811226 | BACKGROUND | PubMed |
| 34334706 | BACKGROUND | PubMed |
| 35081270 | BACKGROUND | PubMed |
| 35084541 | BACKGROUND | PubMed |
| 35957421 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 1-Back Task | Primary outcome | ConductCognition |
| 2-Back Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)