pCO2 Oscillations During Exercise: Relation to Cerebral Blood Flow and to Cognitive Dysfunction in COPD
NCT02660437, Not applicable, Completed, Schön Klinik Berchtesgadener Land
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | pCO2 Oscillations During Exercise: Relation to Cerebral Blood Flow and to Cognitive Dysfunction in COPD | ClinicalTrials.gov |
| NCT number | NCT02660437 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 91 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Schön Klinik Berchtesgadener Land | ClinicalTrials.gov |
| Conditions | Chronic Obstructive Pulmonary Disease | ClinicalTrials.gov |
| Interventions | Pulmonary Rehabilitation program | ClinicalTrials.gov |
| First posted | 2016-01-21 | ClinicalTrials.gov |
| Last updated | 2019-02-28 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Carbon-dioxide partial pressure oscillations (ΔpCO2, mmHg) | Day 4-21 | Changes in transcutaneous pCO2 (ΔpCO2, 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). | ClinicalTrials.gov |
| Secondary | Cognitive Dysfunction (yes/no) | Day 1-3 | Screening of Cognitive Dysfunction according to Petersen's criteria: 1. Consistent memory complaints preferably corroborated by a close-informant. 2. 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). 3. Preserved ability to perform activities of daily living (ADLs), or minimal impairment if considering instrumental ADLs. 4. Normal global cognitive function. 5. Absence of dementia (Clinical Dementia Rating Scale (CDR ≤1 point)). | ClinicalTrials.gov |
| Secondary | Cognitive Impairment (Standardized Mini-Mental State Examination [SMMSE, scores]) | Day 1-21 | 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). | ClinicalTrials.gov |
| Secondary | Cognitive Impairment (Addenbrooke's Cognitive Examination [ACE-R]) | Day 1-21 | 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). | ClinicalTrials.gov |
| Secondary | Cognitive Impairment (Montreal-Cognitive Assessment [MoCA, scores]) | Day 1-21 | 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). | ClinicalTrials.gov |
| Secondary | Cognitive Impairment (Telephone Interview for Cognitive Status [TICS]) | Day 1-21 | 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). | ClinicalTrials.gov |
| Secondary | Cognitive Performance (Stroop test [reaction-time, seconds]) | Day 4-21 | 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). | ClinicalTrials.gov |
| Secondary | Cerebral Blood Flow Velocity (CBFv, cm/sec) | Day 4-21 | 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). | ClinicalTrials.gov |
| Secondary | Frontal cortex cerebrovascular oxygen saturation (Tissue Oxygen Saturation [TOI, %]) | Day 4-21 | 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). | ClinicalTrials.gov |
| Secondary | Frontal cortex cerebrovascular oxygen saturation (Changes in Deoxygenated Haemoglobin [ΔHHb, μM/cm]) | Day 4-21 | Measurement of the changes in Deoxygenated Haemoglobin (ΔHHb) 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 (ΔHHb, 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). | ClinicalTrials.gov |
| Other | Airflow limitation (Forced Expiratory Pressure in 1 Second [FEV1, %predicted]) | Day 1-4 | Measurement of Forced Expiratory Pressure in 1 Second (FEV1, %predicted). | ClinicalTrials.gov |
| Other | Exercise capacity (peak Work Rate, [WRpeak watts]) | Day 1-6 | 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. | ClinicalTrials.gov |
| Other | Blood Gas Analyses (Arterial oxygen partial pressure [PaO2, mmHg]) | Day 1-6 | Measurement of arterial oxygen partial pressure (PaO2, mmHg) in blood samples. | ClinicalTrials.gov |
| Other | Blood Gas Analyses (Arterial carbon-dioxide partial pressure [PaCO2, mmHg]) | Day 1-6 | Measurement of arterial carbon-dioxide partial pressure (PaCO2, mmHg) in blood samples. | ClinicalTrials.gov |
| Other | Brain Derived Neurotrophic Factor (BDNF serum levels, ng/mL). | Day 1-8 | Measurement of serum levels of Brain Derived Neurotrophic Factor (BDNF, ng/mL) in blood samples. | ClinicalTrials.gov |
| Other | Psychological condition/ Psychological data (Hospital Anxiety and Depression Scale [HADS, scores]) | Day 5-8 | Psychological factors will be assessed by the use of the Hospital Anxiety and Depression Scale (HADS). | ClinicalTrials.gov |
| Other | Psychological condition/ Psychological data (COPD Assessment Test [CAT, scores]) | Day 5-8 | Psychological factors will be assessed by the use of the COPD Assessment Test (CAT). | ClinicalTrials.gov |
| Other | Psychological condition/ Psychological data (St. George Respiratory Questionnaire [SGRQ, scores]) | Day 5-8 | Psychological factors will be assessed by the use of the St. George Respiratory Questionnaire (SGRQ). | ClinicalTrials.gov |
| Other | Perception of Dyspnoea (Medical Research Council dyspnoea scale, [MRC scores]) | Day 5-8 | Perception of dyspnoea will be assessed by the use of the Medical Research Council (MRC) dyspnoea scale. | 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 8
The papers the trial lists on ClinicalTrials.gov.
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 1
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 |
|---|---|---|
| Stroop Color-Word Test | Secondary 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)