Cognitive Status in Chronic Obstructive Pulmonary Disease's Patients

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Cognitive assessment

• Registration Number: NCT02143700
• Lead Sponsor: Universidad de Granada

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.

Study Timeline

• Study Start: 2014-04
• Status Verified: 2014-05
• Study First Submitted: 2014-05-17
• Study First Submitted QC: 2014-05-17
• Last Update Submitted: 2014-05-17
• Study First Posted: 2014-05-21
• Last Update Posted: 2014-05-21
• Primary Completion: 2014-08
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stable and exacerbated patients	Cognitive assessment	Patients diagnosed of chronic obstructive pulmonary disease in a stable or exacerbated situation. Cognitive assessment of these patients will be performed.

Primary Outcome Measures

Name	Time	Method
Cognitive impairment	Baseline	The 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 Outcome Measures

Name	Time	Method
Sleep quality	Baseline	Participants 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.
Activity monitoring	Baseline	The accelerometer Armband is going to be used for activity monitoring. It measures the intensity of the activity during 12 hours.
Nutritional state	Baseline	Mini 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 life	Baseline	Quality of life associated with health is going to be measured with two questionnaires: the EuroQol-5 questionnaire and the Health Questionnaire St. George
Cough	Baseline	The Leicester Cough Questionnaire-acute is a validated cough-related health status questionnaire designed for patients with chronic cough.
Comorbidities	Baseline	Comorbidities 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.
Anxiety and depression	Baseline	Patients are going to completed the Hospital Anxiety and Depression Scale composed of statements relevant to either generalized anxiety or depression.
Cognitive flexibility	Baseline	The 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 capacity	Baseline	Forced vital capacity is going to be measured with a spirometer as recommended by the American Thoracic Society
Forced expiratory volume in the first second	Baseline	Forced expiratory volume in the first second is going to be measured with a spirometer as recommended by the American Thoracic Society

Trial Locations

Locations (1)

Department of Physical Therapy; 🇪🇸 Granada, Spain