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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05137483
Other study ID # IKC125
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 19, 2021
Est. completion date July 30, 2022

Study information

Verified date November 2021
Source Izmir Katip Celebi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date July 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers
Gender All
Age group 45 Years and older
Eligibility 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 Design


Intervention

Other:
Functional tests
We will apply upper extremity performance tests, hand grip measurements, and scales measuring fatigue and quality of life to the groups.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Izmir Katip Celebi University

Outcome

Type Measure Description Time frame Safety issue
Primary 6 min. pegboard ring test It is used to measure upper extremity functional capacity. 6 minutes
Secondary Mini Mental State Test It is used for measuring cognitive impairment 15 minutes
Secondary Montreal Cognitive Assessment Scale It is used for measuring cognitive impairment 30 minutes
Secondary Respiratory Function Test It is used for measuring lung functions and respiratory muscle strength 20 minutes
Secondary Fatigue Impact Scale It is used for measuring fatigue level Time Frame: 20 minutes
Secondary St. George Respiratory Questionnaire It is used for measuring desase-related quality of life 20 minutes
Secondary COPD Assessment Test It is used for measuring health status of COPD patients 10 minutes
Secondary mMRC Dyspnea Scale It is used for measuring dyspnea sensation in daily living activities 5 minutes
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