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Cognitive Status in Chronic Obstructive Pulmonary Disease's Patients

Clinical Profile and Cognitive Status in Chronic Obstructive Pulmonary Disease's Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02143700
Acronym
COPD
Enrollment
60
Registered
2014-05-21
Start date
2014-04-30
Completion date
2014-12-31
Last updated
2014-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

exacerbation, cognitive, chronic obstructive pulmonary disease

Brief summary

Chronic obstructive pulmonary disease (COPD) is a chronic condition involving an impairment in functionality and in the execution of activities of daily life. The hypothesis of this study is to examine the relationship between cognitive status and clinical profile (respiratory, sleep quality, nutritional status) in patients with chronic obstructive pulmonary disease in two different moments: exacerbation or stable situation.

Detailed description

Chronic obstructive pulmonary disease is a pathology with a systemic impact with a progressive evolution that is characterized by the presence of chronic airflow obstruction. Patients with COPD may have problems with cognitive functioning, either globally or in single cognitive domains, such as information processing, attention and concentration, memory, executive functioning and self-regulation. Several studies have determined the prevalence of cognitive impairment in COPD compared to healthy control subjects, reaching very high levels, 36% of COPD patients with mild cognitive impairment compared with 12 % non- COPD subjects.

Interventions

OTHERCognitive assessment

Patients are going to be assessed regarding the outcome measures

Sponsors

Universidad de Granada
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of chronic obstructive pulmonary disease with exacerbation or stable. * Signed written consent. * Medical approval for inclusion

Exclusion criteria

* Heart disease. * Neurological patients. * Severe cognitive impairment in order not to complete the assessment.

Design outcomes

Primary

MeasureTime frameDescription
Cognitive impairmentBaselineThe cognitive impairment will be measured using the Montreal Cognitive Assessment. The Montreal Cognitive Assessment is a test designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.

Secondary

MeasureTime frameDescription
Activity monitoringBaselineThe accelerometer Armband is going to be used for activity monitoring. It measures the intensity of the activity during 12 hours.
Nutritional stateBaselineMini Nutritional Assessment has been designed and validated to provide a single, rapid assessment of nutritional status in elderly patients in outpatient clinics, hospitals, and nursing homes. It is composed of simple measurements and brief questions that can be completed in about 10 min
Quality of lifeBaselineQuality of life associated with health is going to be measured with two questionnaires: the EuroQol-5 questionnaire and the Health Questionnaire St. George
CoughBaselineThe Leicester Cough Questionnaire-acute is a validated cough-related health status questionnaire designed for patients with chronic cough.
Sleep qualityBaselineParticipants are going to complete the Pittsburgh Quality of Sleep Index. This is a self-rating questionnaire with seven subscores that result in a global score between 0 and 21.
Anxiety and depressionBaselinePatients are going to completed the Hospital Anxiety and Depression Scale composed of statements relevant to either generalized anxiety or depression.
Cognitive flexibilityBaselineThe cognitive flexibility of patients is measured using the Trial Making Test. This test explores visual-conceptual and visual-motor tracking, and it is a frequently used neuropsychological test.
Forced vital capacityBaselineForced vital capacity is going to be measured with a spirometer as recommended by the American Thoracic Society
Forced expiratory volume in the first secondBaselineForced expiratory volume in the first second is going to be measured with a spirometer as recommended by the American Thoracic Society
ComorbiditiesBaselineComorbidities are going to be measured with the Charlson comorbidity index. The Charlson comorbidity index predicts the ten-year mortality for a patient who may have a range of comorbid conditions, such as heart disease, AIDS, or cancer (a total of 22 conditions). Each condition is assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one.

Countries

Spain

Contacts

Primary ContactMarie Carmen Valenza, PhD
cvalenza@ugr.es958242360

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026