Cognitive Status in Chronic Obstructive Pulmonary Disease's Patients (COPD)

May 17, 2014 updated by: Marie Carmen Valenza, Universidad de Granada

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18071
        • Recruiting
        • Department of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed of chronic obstructive pulmonary disease.

Description

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 Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stable and exacerbated patients
Patients diagnosed of chronic obstructive pulmonary disease in a stable or exacerbated situation. Cognitive assessment of these patients will be performed.
Other: Cognitive assessment
Patients are going to be assessed regarding the outcome measures
Other Names:
  • observation
  • assessment
  • evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive impairment
Time Frame: 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.
Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Granada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

May 17, 2014

First Submitted That Met QC Criteria

May 17, 2014

First Posted (Estimate)

May 21, 2014

Study Record Updates

Last Update Posted (Estimate)

May 21, 2014

Last Update Submitted That Met QC Criteria

May 17, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DF0051UG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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