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RESCOGCognitive Impairment and Clinical Characteristics in Patients With Chronic Obstructive Pulmonary Disease: Retrospective Study

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What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Mental Disorders+9

+ Chronic Disease

+ Cognition Disorders

+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: April 2020
See protocol details

Summary

Principal SponsorIRCCS San Raffaele
Study ContactIRCCSSanraffaeleMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 28, 2020

Actual date on which the first participant was enrolled.

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.

Official TitleCognitive Impairment and Clinical Characteristics in Patients With Chronic Obstructive Pulmonary Disease: Retrospective Study
NCT04394299
Principal SponsorIRCCS San Raffaele
Study ContactIRCCSSanraffaeleMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1476 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersChronic DiseaseCognition DisordersLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsNeurocognitive DisordersDisease AttributesPulmonary Disease, Chronic ObstructiveCognitive Dysfunction

Criteria

1 inclusion criteria required to participate
All patients admitted consecutively

1 exclusion criteria prevent from participating
None

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

IRCCSSanraffaele

Roma, ItalyOpen IRCCSSanraffaele in Google Maps
SuspendedOne Study Center