NCT04394299

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,476

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

May 26, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

May 14, 2020

Last Update Submit

May 21, 2020

Conditions

COPD

Keywords

COPDCognitive impairmentPulmonary rehabilitationOutcome

Outcome Measures

Primary Outcomes (2)

  • Cognitive impairment

    Mini Mental State Evaluation score from zero to 30

    2 months

  • Response to Pulmonary Rehabilitation

    Evaluation using six minutes walking test

    3 months

Secondary Outcomes (1)

  • Evaluation of responders according to six minutes walking test

    3 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • All patients admitted consecutively

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCSSanraffaele

Roma, 00166, Italy

RECRUITING

Related Publications (13)

  • 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.

    PMID: 27264777BACKGROUND

  • Prinzi 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.

    PMID: 30181485BACKGROUND

  • Yohannes 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.

    PMID: 28292570BACKGROUND

  • Singh 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.

    PMID: 24637951BACKGROUND

  • Cleutjens 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.

    PMID: 24738069BACKGROUND

  • Cleutjens 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.

    PMID: 28553720BACKGROUND

  • Pierobon 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.

    PMID: 28790808BACKGROUND

  • Pierobon 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.

    PMID: 30067787BACKGROUND

  • Baird 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.

    PMID: 28732820BACKGROUND

  • Ozyemisci-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.

    PMID: 26071384BACKGROUND

  • Emery 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.

    PMID: 9619472BACKGROUND

  • Hood 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.

    PMID: 22450380BACKGROUND

  • Wagner 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.

    PMID: 28929311BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveCognitive Dysfunction

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Patrizia Russo, PhD

    IRCCSSanraffaele

    PRINCIPAL INVESTIGATOR

Central Study Contacts

IRCCSSanraffaele

CONTACT

0039065225segreteria.scientifica@sanraffaele.it

Astrid vanRjin, PhD

CONTACT

0039065225astrid.vanrjin@sanraffaele.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 19, 2020

Study Start

April 28, 2020

Primary Completion

June 30, 2020

Study Completion

July 31, 2020

Last Updated

May 26, 2020

Record last verified: 2020-05

Locations

IT(1)