Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Carbon Dioxide Partial Pressure Oscillations During Exercise: Relation to Cerebral Blood Flow Regulation and and to the Prevalence of Cognitive Dysfunction in COPD
NCT number | NCT02660437 |
Other study ID # | RESPIRE2-8465 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | July 2018 |
Verified date | February 2019 |
Source | Klinikum Berchtesgadener Land der Schön-Kliniken |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Investigators wish to identify a relationship between substantial changes in carbon dioxide partial-pressure (pCO2), which frequently occur during the transitions from rest to exercise (ΔpCO2 >4 millimeters of mercury [mmHg] from baseline), and the prevalence of cognitive dysfunction in COPD. In particular, it is anticipated to investigate the vascular effect of pCO2 oscillations in the regulation of cerebral blood flow (CBF) during exercise and its impact on cognitive function in Chronic Obstructive Pulmonary Disease (COPD). Furthermore, this study aims to examine whether major pCO2 oscillations have prognostic value in cognitive deterioration at 6, 12, and 18-month follow-up. In addition, the acute effect of 3-week pulmonary rehabilitation (PR) on cognitive function will be explored. The evaluation of cognitive function will be performed by the use of Standardized Mini Mental State Examination (SMMSE), Addenbrooke's Cognitive Examination (ACE-R), Montreal Cognitive Assessment (MoCA), and Telephone Interview for Cognitive Status (TICS) assessing several cognitive domains (cognitive scores) whereas Stroop test [color reading interference] will be used for measuring cognitive performance (Reaction-Time).
Status | Completed |
Enrollment | 91 |
Est. completion date | July 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients with Chronic Obstructive Pulmonary Disease (COPD) in Global Initiative on Obstructive Lung Disease (GOLD) stages II to IV - COPD patients with mild to moderate cognitive impairment (MCI-group: n=100) and without cognitive impairment (Control-group: n=60) - Normotensive (Blood Pressure range: 101-143/62-91 millimeters of mercury [mmHg]) Exclusion Criteria: - Resting partial pressure of oxygen in arterial blood (paO2) <55 millimeters of mercury [mmHg] - Resting partial pressure of carbon dioxide in arterial blood (paCO2) >45 millimeters of mercury [mmHg] - last exacerbation =4weeks - severe cognitive impairment/dementia - other neuropsychiatric symptoms |
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum Berchtesgadener Land der Schön-Kliniken | Schonau am Konigssee |
Lead Sponsor | Collaborator |
---|---|
Klinikum Berchtesgadener Land der Schön-Kliniken | European Respiratory Society |
Germany,
Ito H, Ibaraki M, Kanno I, Fukuda H, Miura S. Changes in the arterial fraction of human cerebral blood volume during hypercapnia and hypocapnia measured by positron emission tomography. J Cereb Blood Flow Metab. 2005 Jul;25(7):852-7. — View Citation
Ogoh S, Tsukamoto H, Hirasawa A, Hasegawa H, Hirose N, Hashimoto T. The effect of changes in cerebral blood flow on cognitive function during exercise. Physiol Rep. 2014 Sep 28;2(9). pii: e12163. doi: 10.14814/phy2.12163. Print 2014 Sep 1. — View Citation
Payne SJ, Mohammad J, Tisdall MM, Tachtsidis I. Effects of arterial blood gas levels on cerebral blood flow and oxygen transport. Biomed Opt Express. 2011 Mar 25;2(4):966-79. doi: 10.1364/BOE.2.000979. — View Citation
Petersen RC, Smith GE, Waring SC, Ivnik RJ, Tangalos EG, Kokmen E. Mild cognitive impairment: clinical characterization and outcome. Arch Neurol. 1999 Mar;56(3):303-8. Erratum in: Arch Neurol 1999 Jun;56(6):760. — View Citation
Shimada H, Makizako H, Doi T, Yoshida D, Tsutsumimoto K, Anan Y, Uemura K, Lee S, Park H, Suzuki T. A large, cross-sectional observational study of serum BDNF, cognitive function, and mild cognitive impairment in the elderly. Front Aging Neurosci. 2014 Apr 15;6:69. doi: 10.3389/fnagi.2014.00069. eCollection 2014. — View Citation
Valdueza JM, Balzer JO, Villringer A, Vogl TJ, Kutter R, Einhäupl KM. Changes in blood flow velocity and diameter of the middle cerebral artery during hyperventilation: assessment with MR and transcranial Doppler sonography. AJNR Am J Neuroradiol. 1997 Nov-Dec;18(10):1929-34. — View Citation
Van der Elst W, Van Boxtel MP, Van Breukelen GJ, Jolles J. The Stroop color-word test: influence of age, sex, and education; and normative data for a large sample across the adult age range. Assessment. 2006 Mar;13(1):62-79. — View Citation
Vogiatzis I, Louvaris Z, Habazettl H, Andrianopoulos V, Wagner H, Roussos C, Wagner PD, Zakynthinos S. Cerebral cortex oxygen delivery and exercise limitation in patients with COPD. Eur Respir J. 2013 Feb;41(2):295-301. doi: 10.1183/09031936.00016312. Epub 2012 May 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Airflow limitation (Forced Expiratory Pressure in 1 Second [FEV1, %predicted]) | Measurement of Forced Expiratory Pressure in 1 Second (FEV1, %predicted). | Day 1-4 | |
Other | Exercise capacity (peak Work Rate, [WRpeak watts]) | Measurement of exercise capacity by a cardiopulmonary exercise test (CPET) on cycle ergometer using an incremental protocol to the limit of tolerance (peak Work Rate, watts)) for establishing the work rate corresponding to 75% of peak (maximum working capacity) according to the international guidelines. | Day 1-6 | |
Other | Blood Gas Analyses (Arterial oxygen partial pressure [PaO2, mmHg]) | Measurement of arterial oxygen partial pressure (PaO2, mmHg) in blood samples. | Day 1-6 | |
Other | Blood Gas Analyses (Arterial carbon-dioxide partial pressure [PaCO2, mmHg]) | Measurement of arterial carbon-dioxide partial pressure (PaCO2, mmHg) in blood samples. | Day 1-6 | |
Other | Brain Derived Neurotrophic Factor (BDNF serum levels, ng/mL). | Measurement of serum levels of Brain Derived Neurotrophic Factor (BDNF, ng/mL) in blood samples. | Day 1-8 | |
Other | Psychological condition/ Psychological data (Hospital Anxiety and Depression Scale [HADS, scores]) | Psychological factors will be assessed by the use of the Hospital Anxiety and Depression Scale (HADS). | Day 5-8 | |
Other | Psychological condition/ Psychological data (COPD Assessment Test [CAT, scores]) | Psychological factors will be assessed by the use of the COPD Assessment Test (CAT). | Day 5-8 | |
Other | Psychological condition/ Psychological data (St. George Respiratory Questionnaire [SGRQ, scores]) | Psychological factors will be assessed by the use of the St. George Respiratory Questionnaire (SGRQ). | Day 5-8 | |
Other | Perception of Dyspnoea (Medical Research Council dyspnoea scale, [MRC scores]) | Perception of dyspnoea will be assessed by the use of the Medical Research Council (MRC) dyspnoea scale. | Day 5-8 | |
Primary | Carbon-dioxide partial pressure oscillations (?pCO2, mmHg) | Changes in transcutaneous pCO2 (?pCO2, mmHg from baseline values) during Cycle-Endurance Test (CET) at 75% of peak Work Rate (WRpeak). The pCO2 oscillations will be transcutaneous monitored and continuously recorded by the use of "SenTec" Digital Monitoring System (pre/post measurements): 1st measurement during a CET prior to the participation in a 3-week (12 sessions) Pulmonary Rehabilitation program (pre-PR); 2nd measurement during a CET at the end of PR program (post-PR). | Day 4-21 | |
Secondary | Cognitive Dysfunction (yes/no) | Screening of Cognitive Dysfunction according to Petersen's criteria: Consistent memory complaints preferably corroborated by a close-informant. Objective characterization of specific deficits in memory and/or other cognitive domains, as indicated by a poor performance on MoCA (<26 points), MMSE (<25 points), ACE-R (<88 points) and TICS (<33 points). Preserved ability to perform activities of daily living (ADLs), or minimal impairment if considering instrumental ADLs. Normal global cognitive function. Absence of dementia (Clinical Dementia Rating Scale (CDR =1 point)). |
Day 1-3 | |
Secondary | Cognitive Impairment (Standardized Mini-Mental State Examination [SMMSE, scores]) | Evaluation of Cognitive Impairment (CI) by the use of clinical instrument of the Standardized Mini-Mental State Examination (SMMSE, scores); 1st measurement prior to the participation in a 3-week (12 sessions) Pulmonary Rehabilitation program (pre-PR); 2nd measurement at the end of PR program (post-PR). | Day 1-21 | |
Secondary | Cognitive Impairment (Addenbrooke's Cognitive Examination [ACE-R]) | Evaluation of Cognitive Impairment (CI) by the use of clinical instrument of the Addenbrooke's Cognitive Examination (ACE-R scores); 1st measurement prior to the participation in a 3-week (12 sessions) Pulmonary Rehabilitation program (pre-PR); 2nd measurement at the end of PR program (post-PR). | Day 1-21 | |
Secondary | Cognitive Impairment (Montreal-Cognitive Assessment [MoCA, scores]) | Evaluation of Cognitive Impairment (CI) by the use of clinical instrument of the Montreal-Cognitive Assessment (MoCa scores); 1st measurement prior to the participation in a 3-week (12 sessions) Pulmonary Rehabilitation program (pre-PR); 2nd measurement at the end of PR program (post-PR). | Day 1-21 | |
Secondary | Cognitive Impairment (Telephone Interview for Cognitive Status [TICS]) | Evaluation of Cognitive Impairment (CI) by the use of clinical instrument of the Telephone Interview for Cognitive Status (TICS scores); 1st measurement prior to the participation in a 3-week (12 sessions) Pulmonary Rehabilitation program (pre-PR); 2nd measurement at the end of PR program (post-PR). | Day 1-21 | |
Secondary | Cognitive Performance (Stroop test [reaction-time, seconds]) | Assessment of cognitive performance (Stroop test - reaction-time, seconds) before and immediately after Cycle-Endurance Test (CET) at 75% of WRpeak. Cognitive performance will be measured by the use of Stroop-test (pre/post measurements): 1st measurement during a CET prior to the participation in a 3-week (12 sessions) Pulmonary Rehabilitation program (pre-PR); 2nd measurement during a CET at the end of PR program (post-PR). | Day 4-21 | |
Secondary | Cerebral Blood Flow Velocity (CBFv, cm/sec) | Measurement of Cerebral Blood Flow velocity (CBFv, cm/sec) as surrogate of Cerebral Blood Flow (CBF) before and immediately after Cycle-Endurance Test (CET) at 75% of WRpeak. Cerebral Blood Flow velocity (CBFv) will be measured by the use of transcranial Doppler ultrasonography (pre/post measurements): 1st measurement during a CET prior to the participation in a 3-week (12 sessions) Pulmonary Rehabilitation program (pre-PR); 2nd measurement during a CET at the end of PR program (post-PR). | Day 4-21 | |
Secondary | Frontal cortex cerebrovascular oxygen saturation (Tissue Oxygen Saturation [TOI, %]) | Measurement Tissue Oxygen Saturation (TOI, %) as an index of frontal cortex cerebrovascular oxygen saturation during Cycle-Endurance Test (CET) at 75% of WRpeak. Tissue oxygen saturation (TOI, %) will be continuously measured by the use of Near-Infrared Spectroscopy (NIRS-method; pre/post measurement): 1st measurement during a CET prior to the participation in a 3-week (12 sessions) Pulmonary Rehabilitation program (pre-PR); 2nd measurement during a CET at the end of PR program (post-PR). | Day 4-21 | |
Secondary | Frontal cortex cerebrovascular oxygen saturation (Changes in Deoxygenated Haemoglobin [?HHb, µM/cm]) | Measurement of the changes in Deoxygenated Haemoglobin (?HHb) in micrometer per centimeter (µM/cm) as an index of frontal cortex cerebrovascular oxygen saturation during Cycle-Endurance Test (CET) at 75% of WRpeak. Changes in Deoxygenated Haemoglobin (?HHb, µM/cm) will be continuously measured by the use of Near-Infrared Spectroscopy (NIRS-method; pre/post measurement): 1st measurement during a CET prior to the participation in a 3-week (12 sessions) Pulmonary Rehabilitation program (pre-PR); 2nd measurement during a CET at the end of PR program (post-PR). | Day 4-21 |
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