COPDCOPDNCT05137483
Cognitive Impairment and Upper Extremity Performance in COPD
An observational study of COPD and Upper Extremity, run by Izmir Katip Celebi University.
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… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- COPD, Upper Extremity, Upper Limb Function
- What is being tested?
- Functional tests
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 19 Nov 2021to 30 Jul 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Adult, Older adult
Study population: COPD patients above 45 years
Who may be able to join
- Volunteering to participate in the study
- Stage 2-3-4 according to the GOLD classification in the 40-65 age range
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- COPD, Upper Extremity, Upper Limb Function, Cognitive Impairment
- Being tested
- Functional tests
- Keywords
- copd, cognitive impairment, cognition, upper extremity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional testsOther
We will apply upper extremity performance tests, hand grip measurements, and scales measuring fatigue and quality of life to the groups.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Functional tests | |
| 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. Receives: Other: Functional tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 min. pegboard ring test
It is used to measure upper extremity functional capacity.
Measured: 6 minutes
Secondary outcomes (7)
Mini Mental State Test
It is used for measuring cognitive impairment
Measured: 15 minutes
Montreal Cognitive Assessment Scale
It is used for measuring cognitive impairment
Measured: 30 minutes
Respiratory Function Test
It is used for measuring lung functions and respiratory muscle strength
Measured: 20 minutes
Fatigue Impact Scale
It is used for measuring fatigue level
Measured: Time Frame: 20 minutes
St. George Respiratory Questionnaire
It is used for measuring desase-related quality of life
Measured: 20 minutes
COPD Assessment Test
It is used for measuring health status of COPD patients
Measured: 10 minutes
mMRC Dyspnea Scale
It is used for measuring dyspnea sensation in daily living activities
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start19 Nov 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilknur Naz, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137483
- Sponsor's protocol ID
- IKC125
- Acronym
- COPD
- Status last verified
- Nov 2021
- First submitted
- 18 Nov 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Upper Extremity Functional Capacity, Respiratory Functions, Fatigue and Quality of Life in Chronic Obstructive Pulmonary Patients With and Without Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05137483
- Acronym / sponsor ID
- COPD / IKC125
- Conditions
- COPD, Upper Extremity, Upper Limb Function, Cognitive Impairment
- Keywords
- copd, cognitive impairment, cognition, upper extremity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 19 Nov 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With cognitive impairment | – | Other: Functional testsPulmonary 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. |
| without cognitive impairment | – | Other: Functional testsPulmonary 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- COPD patients above 45 years
Key inclusion criteria (2 listed)
- Volunteering to participate in the study
- Stage 2-3-4 according to the GOLD classification in the 40-65 age range
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional testsWe will apply upper extremity performance tests, hand grip measurements, and scales measuring fatigue and quality of life to the groups. | Other | With cognitive impairment, without cognitive impairment |
Primary outcome
6 min. pegboard ring test
Time frame: 6 minutes
It is used to measure upper extremity functional capacity.
7 secondary outcomes
Mini Mental State Test
Time frame: 15 minutes
Montreal Cognitive Assessment Scale
Time frame: 30 minutes
Respiratory Function Test
Time frame: 20 minutes
Fatigue Impact Scale
Time frame: Time Frame: 20 minutes
St. George Respiratory Questionnaire
Time frame: 20 minutes
COPD Assessment Test
Time frame: 10 minutes
mMRC Dyspnea Scale
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Upper Extremity, run by Izmir Katip Celebi University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 min. pegboard ring test (time frame: 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.