RESCOGCognitive Impairment and Clinical Characteristics in Patients With Chronic Obstructive Pulmonary Disease: Retrospective Study
Data Collection
Collected from past medical records and data - RetrospectiveMental Disorders+9
+ Chronic Disease
+ Cognition Disorders
Case-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1476 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.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