COPDRESCOGNCT04394299
Cognitive Impairment in COPD Patients
An observational study of COPD, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Prior researches suggest the presence of impaired lung function may be linked to cognitive impairment (CI). A recent study shows that lung disease, and specifically Chronic obstructive pulmonary disease (COPD) are associated to a greater risk of CI in a population of 14,184 individuals followed for over 23 years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD
- How many people
- 1,476 participants
- Where
- 1 siteItaly
- Study dates
- 28 Apr 2020to 31 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients with moderate to very severe diagnosis of COPD, based on GOLD criteria [Global Initiative for Chronic Obstructive Lung Disease. Report 2020 https://goldcopd.org/wp-content/uploads/2019/11/GOLD-2020-REPORT-ver1.0wms.pdf], who were admitted to inpatient clinic for a period of 3-4 weeks of comprehensive interdisciplinary pulmonary rehabilitation (PR) program from January 2012 to December 2019.
Who may be able to join
- All patients admitted consecutively
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCSSanraffaele
Roma, 00166
Patrizia Russo, Phd, 00393483339704, patrizia:russo@sanraffaele.it
About this study
Official title: Cognitive Impairment and Clinical Characteristics in Patients With Chronic Obstructive Pulmonary Disease: Retrospective Study
Prior researches suggest the presence of impaired lung function may be linked to cognitive impairment (CI). A recent study shows that lung disease, and specifically Chronic obstructive pulmonary disease (COPD) are associated to a greater risk of CI in a population of 14,184 individuals followed for over 23 years. Moreover, the study shows that low forced expiratory volume in 1 second (FEV1) is associated to an increased risk of dementia and MCI, indipendently of smoking habit.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is considered "a progressive but potentially treatable and preventable disease". The clinical view of COPD is moved from a lung-centered model to a novel one that considers COPD as an "umbrella" term encompassing different pulmonary and extra-pulmonary manifestations.
Prior researches suggest the presence of impaired lung function may be linked to cognitive impairment (CI). Among these studies, one prospective found that a diagnosis of COPD is associated with an increased risk of mild cognitive impairment (MCI), mainly nonamnestic MCI (NA-MCI), in a dose-response relationship between COPD duration and risk of MCI. Moreover, CI associated with severe COPD stage increases mortality. Among these studies only one shows that CI decreases adherence to pharmacological and non-pharmacological therapies. However, while it is well known that an MMSE score of 23-24 points or less is predictive of poor inhaler technique no studies report the impact of CI on PR outcomes. It has been reported that patients with MMSE < 24 walk lesser, at the basal level, than patients with a MMSE score > 24 (146 ±134 versus 242 ± 152 m) in the six minutes walking tests (6MWT) but no data are reported after rehabilitation. On the other hand, some papers report an association between participation in exercise rehabilitation programs and enhanced performance on cognitive tests.
The aim of this study is to compare cognitive functioning in patients with COPD referred for pulmonary rehabilitation to the response of the programme itself. More specific objectives of the present study are to:
- Study whether and to what extent CI in patients with COPD impacts outcomes of pulmonary rehabilitation such as 6MW distance (6MWD), Barthel and Borg scales for assessing dyspnea, Maugeri Foundation Respiratory Failure Questionnaire and the disease-specific respiratory quality of life (QoL) [St. George's Respiratory Questionnaire (SGRQ) and the Medical Research Council (MRC)].
- Investigate clinical and demographic characteristics of patients with COPD with cognitive impairment.
The hypothesize is that COPD patients with CI have worse response to PR compared with patients with no CI.
These results are important on the light of a personalized approach according to the so called "P4 medicine", for predictive, preventive, personalized and participatory Recently, the so-called "Rehabilomics" research framework, initially introduced r in traumatic brain injury rehabilitation, was applied on COPD rehabilitation. The "Rehabilomics" represents an exclusive and distinctive model in the path of the personalized-medicine approaches to rehabilitation. Thus, in previousstudy the Rehabilomics-like approach was used to afford the complexity of COPD rehabilitation, incorporating social/demographic data (i.e. gender, education, presence of a caregiver) clinical, psychological/emotional traits, genetics (i.e. DNA variants) and biological factors (i.e. DNA damage, levels of interleukins, et cet.) in a real life setting.
- Conditions
- COPD
- Keywords
- COPD, Cognitive impairment, Pulmonary rehabilitation, Outcome
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive impairment
Mini Mental State Evaluation score from zero to 30
Measured: 2 months
Response to Pulmonary Rehabilitation
Evaluation using six minutes walking test
Measured: 3 months
Secondary outcomes (1)
Evaluation of responders according to six minutes walking test
Patients able to walk for more of 30 meter after rehabilitation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start28 Apr 2020
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 1,476 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Patrizia Russo, IRCCS San Raffaele
- Investigators
- Patrizia Russo, PhD, Principal investigator, IRCCSSanraffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394299
- Sponsor's protocol ID
- IRCCSSanRaffaele
- Acronym
- RESCOG
- Status last verified
- May 2020
- First submitted
- 14 May 2020
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vanfleteren LEGW, Spruit MA, Wouters EFM, Franssen FME. Management of chronic obstructive pulmonary disease beyond the lungs. Lancet Respir Med. 2016 Nov;4(11):911-924. doi: 10.1016/S2213-2600(16)00097-7. Epub 2016 Jun 2.
PubMed 27264777Prinzi G, Santoro A, Lamonaca P, Cardaci V, Fini M, Russo P. Cognitive Impairment in Chronic Obstructive Pulmonary Disease (COPD): Possible Utility of Marine Bioactive Compounds. Mar Drugs. 2018 Sep 4;16(9):313. doi: 10.3390/md16090313.
PubMed 30181485Yohannes AM, Chen W, Moga AM, Leroi I, Connolly MJ. Cognitive Impairment in Chronic Obstructive Pulmonary Disease and Chronic Heart Failure: A Systematic Review and Meta-analysis of Observational Studies. J Am Med Dir Assoc. 2017 May 1;18(5):451.e1-451.e11. doi: 10.1016/j.jamda.2017.01.014. Epub 2017 Mar 11.
PubMed 28292570Singh B, Mielke MM, Parsaik AK, Cha RH, Roberts RO, Scanlon PD, Geda YE, Christianson TJ, Pankratz VS, Petersen RC. A prospective study of chronic obstructive pulmonary disease and the risk for mild cognitive impairment. JAMA Neurol. 2014 May;71(5):581-8. doi: 10.1001/jamaneurol.2014.94.
PubMed 24637951Cleutjens FA, Janssen DJ, Ponds RW, Dijkstra JB, Wouters EF. COgnitive-pulmonary disease. Biomed Res Int. 2014;2014:697825. doi: 10.1155/2014/697825. Epub 2014 Mar 16.
PubMed 24738069Cleutjens FAHM, Spruit MA, Ponds RWHM, Vanfleteren LEGW, Franssen FME, Gijsen C, Dijkstra JB, Wouters EFM, Janssen DJA. Cognitive impairment and clinical characteristics in patients with chronic obstructive pulmonary disease. Chron Respir Dis. 2018 May;15(2):91-102. doi: 10.1177/1479972317709651. Epub 2017 May 29.
PubMed 28553720Pierobon A, Sini Bottelli E, Ranzini L, Bruschi C, Maestri R, Bertolotti G, Sommaruga M, Torlaschi V, Callegari S, Giardini A. COPD patients' self-reported adherence, psychosocial factors and mild cognitive impairment in pulmonary rehabilitation. Int J Chron Obstruct Pulmon Dis. 2017 Jul 18;12:2059-2067. doi: 10.2147/COPD.S133586. eCollection 2017.
PubMed 28790808Pierobon A, Ranzini L, Torlaschi V, Sini Bottelli E, Giardini A, Bruschi C, Maestri R, Callegari S, Raccanelli R, Sommaruga M. Screening for neuropsychological impairment in COPD patients undergoing rehabilitation. PLoS One. 2018 Aug 1;13(8):e0199736. doi: 10.1371/journal.pone.0199736. eCollection 2018.
PubMed 30067787Baird C, Lovell J, Johnson M, Shiell K, Ibrahim JE. The impact of cognitive impairment on self-management in chronic obstructive pulmonary disease: A systematic review. Respir Med. 2017 Aug;129:130-139. doi: 10.1016/j.rmed.2017.06.006. Epub 2017 Jun 15.
PubMed 28732820Ozyemisci-Taskiran O, Bozkurt SO, Kokturk N, Karatas GK. Is there any association between cognitive status and functional capacity during exacerbation of chronic obstructive pulmonary disease? Chron Respir Dis. 2015 Aug;12(3):247-55. doi: 10.1177/1479972315589748. Epub 2015 Jun 11.
PubMed 26071384Emery CF, Schein RL, Hauck ER, MacIntyre NR. Psychological and cognitive outcomes of a randomized trial of exercise among patients with chronic obstructive pulmonary disease. Health Psychol. 1998 May;17(3):232-40. doi: 10.1037//0278-6133.17.3.232.
PubMed 9619472Hood L, Flores M. A personal view on systems medicine and the emergence of proactive P4 medicine: predictive, preventive, personalized and participatory. N Biotechnol. 2012 Sep 15;29(6):613-24. doi: 10.1016/j.nbt.2012.03.004. Epub 2012 Mar 18.
PubMed 22450380Wagner AK. TBI Rehabilomics Research: an Exemplar of a Biomarker-Based Approach to Precision Care for Populations with Disability. Curr Neurol Neurosci Rep. 2017 Sep 19;17(11):84. doi: 10.1007/s11910-017-0791-5.
PubMed 28929311
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairment and Clinical Characteristics in Patients With Chronic Obstructive Pulmonary Disease: Retrospective Study
- ClinicalTrials.gov ID
- NCT04394299
- Acronym / sponsor ID
- RESCOG / IRCCSSanRaffaele
- Conditions
- COPD
- Keywords
- COPD, Cognitive impairment, Pulmonary rehabilitation, Outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,476 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 19 May 2020 (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.
Prior researches suggest the presence of impaired lung function may be linked to cognitive impairment (CI). A recent study shows that lung disease, and specifically Chronic obstructive pulmonary disease (COPD) are associated to a greater risk of CI in a population of 14,184 individuals followed for over 23 years. Moreover, the study shows that low forced expiratory volume in 1 second (FEV1) is associated to an increased risk of dementia and MCI, indipendently of smoking habit.
Detailed description
Chronic obstructive pulmonary disease (COPD) is considered "a progressive but potentially treatable and preventable disease". The clinical view of COPD is moved from a lung-centered model to a novel one that considers COPD as an "umbrella" term encompassing different pulmonary and extra-pulmonary manifestations.
Prior researches suggest the presence of impaired lung function may be linked to cognitive impairment (CI). Among these studies, one prospective found that a diagnosis of COPD is associated with an increased risk of mild cognitive impairment (MCI), mainly nonamnestic MCI (NA-MCI), in a dose-response relationship between COPD duration and risk of MCI. Moreover, CI associated with severe COPD stage increases mortality. Among these studies only one shows that CI decreases adherence to pharmacological and non-pharmacological therapies. However, while it is well known that an MMSE score of 23-24 points or less is predictive of poor inhaler technique no studies report the impact of CI on PR outcomes. It has been reported that patients with MMSE < 24 walk lesser, at the basal level, than patients with a MMSE score > 24 (146 ±134 versus 242 ± 152 m) in the six minutes walking tests (6MWT) but no data are reported after rehabilitation. On the other hand, some papers report an association between participation in exercise rehabilitation programs and enhanced performance on cognitive tests.
The aim of this study is to compare cognitive functioning in patients with COPD referred for pulmonary rehabilitation to the response of the programme itself. More specific objectives of the present study are to:
- Study whether and to what extent CI in patients with COPD impacts outcomes of pulmonary rehabilitation such as 6MW distance (6MWD), Barthel and Borg scales for assessing dyspnea, Maugeri Foundation Respiratory Failure Questionnaire and the disease-specific respiratory quality of life (QoL) [St. George's Respiratory Questionnaire (SGRQ) and the Medical Research Council (MRC)].
- Investigate clinical and demographic characteristics of patients with COPD with cognitive impairment.
The hypothesize is that COPD patients with CI have worse response to PR compared with patients with no CI.
These results are important on the light of a personalized approach according to the so called "P4 medicine", for predictive, preventive, personalized and participatory Recently, the so-called "Rehabilomics" research framework, initially introduced r in traumatic brain injury rehabilitation, was applied on COPD rehabilitation. The "Rehabilomics" represents an exclusive and distinctive model in the path of the personalized-medicine approaches to rehabilitation. Thus, in previousstudy the Rehabilomics-like approach was used to afford the complexity of COPD rehabilitation, incorporating social/demographic data (i.e. gender, education, presence of a caregiver) clinical, psychological/emotional traits, genetics (i.e. DNA variants) and biological factors (i.e. DNA damage, levels of interleukins, et cet.) in a real life setting.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients with moderate to very severe diagnosis of COPD, based on GOLD criteria [Global Initiative for Chronic Obstructive Lung Disease. Report 2020 https://goldcopd.org/wp-content/uploads/2019/11/GOLD-2020-REPORT-ver1.0wms.pdf], who were admitted to inpatient clinic for a period of 3-4 weeks of comprehensive interdisciplinary pulmonary rehabilitation (PR) program from January 2012 to December 2019.
Key inclusion criteria (1 listed)
- All patients admitted consecutively
Key exclusion criteria (1 listed)
- None
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
Cognitive impairment
Time frame: 2 months
Mini Mental State Evaluation score from zero to 30
Response to Pulmonary Rehabilitation
Time frame: 3 months
Evaluation using six minutes walking test
1 secondary outcome
Evaluation of responders according to six minutes walking test
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Background: PubMed 27264777Vanfleteren LEGW, Spruit MA, Wouters EFM, Franssen FME. Management of chronic obstructive pulmonary disease beyond the lungs. Lancet Respir Med. 2016 Nov;4(11):911-924. doi: 10.1016/S2213-2600(16)00097-7. Epub 2016 Jun 2.
- Background: PubMed 30181485Prinzi G, Santoro A, Lamonaca P, Cardaci V, Fini M, Russo P. Cognitive Impairment in Chronic Obstructive Pulmonary Disease (COPD): Possible Utility of Marine Bioactive Compounds. Mar Drugs. 2018 Sep 4;16(9):313. doi: 10.3390/md16090313.
- Background: PubMed 28292570Yohannes AM, Chen W, Moga AM, Leroi I, Connolly MJ. Cognitive Impairment in Chronic Obstructive Pulmonary Disease and Chronic Heart Failure: A Systematic Review and Meta-analysis of Observational Studies. J Am Med Dir Assoc. 2017 May 1;18(5):451.e1-451.e11. doi: 10.1016/j.jamda.2017.01.014. Epub 2017 Mar 11.
- Background: PubMed 24637951Singh B, Mielke MM, Parsaik AK, Cha RH, Roberts RO, Scanlon PD, Geda YE, Christianson TJ, Pankratz VS, Petersen RC. A prospective study of chronic obstructive pulmonary disease and the risk for mild cognitive impairment. JAMA Neurol. 2014 May;71(5):581-8. doi: 10.1001/jamaneurol.2014.94.
- Background: PubMed 24738069Cleutjens FA, Janssen DJ, Ponds RW, Dijkstra JB, Wouters EF. COgnitive-pulmonary disease. Biomed Res Int. 2014;2014:697825. doi: 10.1155/2014/697825. Epub 2014 Mar 16.
- Background: PubMed 28553720Cleutjens FAHM, Spruit MA, Ponds RWHM, Vanfleteren LEGW, Franssen FME, Gijsen C, Dijkstra JB, Wouters EFM, Janssen DJA. Cognitive impairment and clinical characteristics in patients with chronic obstructive pulmonary disease. Chron Respir Dis. 2018 May;15(2):91-102. doi: 10.1177/1479972317709651. Epub 2017 May 29.
- Background: PubMed 28790808Pierobon A, Sini Bottelli E, Ranzini L, Bruschi C, Maestri R, Bertolotti G, Sommaruga M, Torlaschi V, Callegari S, Giardini A. COPD patients' self-reported adherence, psychosocial factors and mild cognitive impairment in pulmonary rehabilitation. Int J Chron Obstruct Pulmon Dis. 2017 Jul 18;12:2059-2067. doi: 10.2147/COPD.S133586. eCollection 2017.
- Background: PubMed 30067787Pierobon A, Ranzini L, Torlaschi V, Sini Bottelli E, Giardini A, Bruschi C, Maestri R, Callegari S, Raccanelli R, Sommaruga M. Screening for neuropsychological impairment in COPD patients undergoing rehabilitation. PLoS One. 2018 Aug 1;13(8):e0199736. doi: 10.1371/journal.pone.0199736. eCollection 2018.
- Background: PubMed 28732820Baird C, Lovell J, Johnson M, Shiell K, Ibrahim JE. The impact of cognitive impairment on self-management in chronic obstructive pulmonary disease: A systematic review. Respir Med. 2017 Aug;129:130-139. doi: 10.1016/j.rmed.2017.06.006. Epub 2017 Jun 15.
- Background: PubMed 26071384Ozyemisci-Taskiran O, Bozkurt SO, Kokturk N, Karatas GK. Is there any association between cognitive status and functional capacity during exacerbation of chronic obstructive pulmonary disease? Chron Respir Dis. 2015 Aug;12(3):247-55. doi: 10.1177/1479972315589748. Epub 2015 Jun 11.
- Background: PubMed 9619472Emery CF, Schein RL, Hauck ER, MacIntyre NR. Psychological and cognitive outcomes of a randomized trial of exercise among patients with chronic obstructive pulmonary disease. Health Psychol. 1998 May;17(3):232-40. doi: 10.1037//0278-6133.17.3.232.
- Background: PubMed 22450380Hood L, Flores M. A personal view on systems medicine and the emergence of proactive P4 medicine: predictive, preventive, personalized and participatory. N Biotechnol. 2012 Sep 15;29(6):613-24. doi: 10.1016/j.nbt.2012.03.004. Epub 2012 Mar 18.
- Individual participant dataSharing planned: Undecided
Related trials for COPD
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruitingPhase 2
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
COPD
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. This study is not recruiting at the moment.
Patrizia Russo, PhD principal investigator
IRCCSSanraffaele
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, run by IRCCS San Raffaele at 1 site in Italy.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 May 2020. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact IRCCSSanraffaele (0039065225 ext. 3304, segreteria.scientifica@sanraffaele.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive impairment (time frame: 2 months). The study lists 2 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 NCT04394299, which also lists 13 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 26 May 2020.