Cognitive Impairment and Upper Extremity Performance in COPD (COPD)

November 18, 2021 updated by: Ilknur Naz, Izmir Katip Celebi University

Comparison of Upper Extremity Functional Capacity, Respiratory Functions, Fatigue and Quality of Life in Chronic Obstructive Pulmonary Patients With and Without Cognitive Impairment

Within the scope of this study, COPD patients will be divided into two groups according to cognitive dysfunction.

Pulmonary function test, COPD assessment scale, Mini-Mental State Examination and Montreal Cognitive Assessment Scale, 6 min pegboard ring test, grip strength measurement, Fatigue Impact Scale and St.George Respiratory Questionnaire will be applied to the groups.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Detailed Description

Although the mechanism of cognitive dysfunction in COPD is not clear, the reasons focused on are; decreased oxygen use, high carbon dioxide levels, increased inflammation and oxidative stress, decreased physical activity, peripheral vascular diseases, atherosclerosis, high or low blood pressure, cerebral vasoconstriction, increased intracranial pressure, accompanying comorbidities, smoking and genetic predisposition, brain damage and exacerbations have been reported. Few studies have shown that cognitive dysfunction is associated with functional performance. There are no studies on the effect of cognitive function on upper extremity performance and mechanisms of action in COPD patients.

The aim of this study is to compare upper extremity functional capacities, respiratory functions, fatigue and quality of life in COPD patients with and without cognitive function impairment.

Within the scope of this study, COPD patients will be divided into two groups according to cognitive dysfunction.

Pulmonary function test, COPD assessment scale, Mini-Mental State Examination and Montreal Cognitive Assessment Scale, 6 min pegboard ring test, grip strength measurement, Fatigue Impact Scale and St.George Respiratory Questionnaire will be applied to the groups.

Study Type

Observational

Enrollment (Anticipated)

80

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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COPD patients above 45 years

Description

Inclusion Criteria:

  • Volunteering to participate in the study
  • Stage 2-3-4 according to the GOLD classification in the 40-65 age range

Exclusion Criteria:

  • Exacerbation of respiratory symptoms in the past 4 weeks (change in breathlessness and/or sputum volume/color, need for antibiotic treatment or need for hospitalization)
  • Presence of asthma, unstable coronary heart disease, uncontrolled diabetes, hypertension, left-sided congestive heart failure, neoplasia, severe claudication, encephalitis or epilepsy
  • Having a history of head trauma or brain tumor
  • Having a significant psychiatric condition or the presence of defined dementia, according to the American Psychiatric Association

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
With cognitive impairment
Pulmonary function test, COPD assessment scale, Mini-Mental State Examination and Montreal Cognitive Assessment Scale, 6 min pegboard ring test, grip strength measurement, Fatigue Impact Scale and St.George Respiratory Questionnaire will be applied to the group.
We will apply upper extremity performance tests, hand grip measurements, and scales measuring fatigue and quality of life to the groups.
without cognitive impairment
Pulmonary function test, COPD assessment scale, Mini-Mental State Examination and Montreal Cognitive Assessment Scale, 6 min pegboard ring test, grip strength measurement, Fatigue Impact Scale and St.George Respiratory Questionnaire will be applied to the group.
We will apply upper extremity performance tests, hand grip measurements, and scales measuring fatigue and quality of life to the groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 min. pegboard ring test
Time Frame: 6 minutes
It is used to measure upper extremity functional capacity.
6 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini Mental State Test
Time Frame: 15 minutes
It is used for measuring cognitive impairment
15 minutes
Montreal Cognitive Assessment Scale
Time Frame: 30 minutes
It is used for measuring cognitive impairment
30 minutes
Respiratory Function Test
Time Frame: 20 minutes
It is used for measuring lung functions and respiratory muscle strength
20 minutes
Fatigue Impact Scale
Time Frame: Time Frame: 20 minutes
It is used for measuring fatigue level
Time Frame: 20 minutes
St. George Respiratory Questionnaire
Time Frame: 20 minutes
It is used for measuring desase-related quality of life
20 minutes
COPD Assessment Test
Time Frame: 10 minutes
It is used for measuring health status of COPD patients
10 minutes
mMRC Dyspnea Scale
Time Frame: 5 minutes
It is used for measuring dyspnea sensation in daily living activities
5 minutes

Collaborators and Investigators

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

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 (Anticipated)

November 19, 2021

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

July 30, 2022

Study Registration Dates

First Submitted

November 18, 2021

First Submitted That Met QC Criteria

November 18, 2021

First Posted (Actual)

November 30, 2021

Study Record Updates

Last Update Posted (Actual)

November 30, 2021

Last Update Submitted That Met QC Criteria

November 18, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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