Hemodynamic Responses and Brain Activity During Dual Tasks in COPD Patients Versus Healthy Individuals

NCT06974448 | Not Yet Recruiting DMC

• 1 other identifier: SBA 24/860
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

COPD - Chronic Obstructive Pulmonary Disease; Healty Controls

Keywords

COPD - Chronic Obstructive Pulmonary Disease; dual task; cognitive function; electroencephalogram; Functional Near-Infrared Spectroscopy

Outcome Measures

Primary Outcomes (6)

• 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

  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.

  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.

  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.

  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.

  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.

  through study completion, an average of 1 year

Secondary Outcomes (16)

• Demographic Assessment

  baseline

• Charlson Comorbidity Index

  baseline

• Forced expiratory volume in one second

  through study completion, an average of 1 year

• Forced vital capacity

  through study completion, an average of 1 year

• Forced expiratory volume in one second/forced vital capacity ratio

  through study completion, an average of 1 year

Study Arms (2)

COPD Group

Control Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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
• Not being willing to participate in the study
• Having a known chronic health problem
• Not being willing to participate in the study

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, 06000, Turkey (Türkiye)

Location

Related Publications (16)

• 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.

  PMID: 10826123 BACKGROUND

• Polatli 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.

  PMID: 23875584 BACKGROUND

• Zhang 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.

  PMID: 24862561 BACKGROUND

• Nasreddine 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.

  PMID: 15817019 BACKGROUND

• Gungen 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.

  PMID: 12794644 BACKGROUND

• Holland 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.

  PMID: 25359355 BACKGROUND

• Hankinson 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.

  PMID: 9872837 BACKGROUND

• Kaygusuz 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.

  PMID: 35081270 BACKGROUND

• Alvarez-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.

  PMID: 32106748 BACKGROUND

• Li 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.

  PMID: 35957421 BACKGROUND

• Reijnders 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.

  PMID: 32038311 BACKGROUND

• Hassan 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.

  PMID: 35084541 BACKGROUND

• Hassan 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.

  PMID: 32441147 BACKGROUND

• Gore 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.

  PMID: 34334706 BACKGROUND

• Wen 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.

  PMID: 29369175 BACKGROUND

• Higbee DH, Dodd JW. Cognitive impairment in COPD: an often overlooked co-morbidity. Expert Rev Respir Med. 2021 Jan;15(1):9-11. doi: 10.1080/17476348.2020.1811090. Epub 2020 Aug 26. No abstract available.

  PMID: 32811226 BACKGROUND

Related Links

• GLOBAL STRATEGY FOR PREVENTION, DIAGNOSIS AND MANAGEMENT OF COPD: 2023 Report

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Melike Mese- Buran, Msc, PT.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melike Mese Buran, Msc, PT.

CONTACT

+90 5070045210; melikemese@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, PT

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: May 16, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): October 9, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

TU (1)