- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05137483
Cognitive Impairment and Upper Extremity Performance in COPD (COPD)
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
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
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IKC125
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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