Cognitive Status in Chronic Obstructive Pulmonary Disease's Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

— COPD  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02143700
• Other study ID #: DF0051UG
• Status: Unknown status
• Phase: N/A
• First received: May 17, 2014
• Last updated: May 17, 2014
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: May 2014
• Source: Universidad de Granada
• Contact: Marie Carmen Valenza, PhD
• Phone: 958242360
• Email: cvalenza[@]ugr.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Cognitive assessment
Patients are going to be assessed regarding the outcome measures

Locations

Country	Name	City	State
Spain	Department of Physical Therapy	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

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