Coronary Artery DiseaseNCT06246201
The Relationship Between Cognitive Status and Exercise Capacity, Fatigue Perception in Coronary Artery Patients
An observational study of Coronary Artery Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The study aimed to examine the relationship between cognitive status, exercise capacity, and fatigue perception in coronary artery disease patients. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 23 Feb 2024
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are 18 years old and older and are diagnosed with coronary artery disease.
Who may be able to join
- Volunteering to participate in the research
- Being diagnosed with coronary artery disease
- To cooperate with the tests to be performed
- Signing a consent form
Who cannot join
- Presence of neurological disease that may affect cognitive status
- Presence of clinically unstable cardiac disease
- Left ventricular ejection fraction <30%
- Being diagnosed with end-stage renal failure
- Diagnosed with active myocarditis or pericarditis
- Being diagnosed with rhythm disorder
- Having amputation, peripheral arterial disease, musculoskeletal and/or neurological diseases that will prevent participation in functional capacity tests
- Not volunteering to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation of The Relationship Between Cognitive Status and Exercise Capacity, Fatigue Perception in Coronary Artery Patients
The study aimed to examine the relationship between cognitive status, exercise capacity, and fatigue perception in coronary artery disease patients.
Read the detailed description
Exercise training for patients with coronary artery disease is an essential element of multicomponent cardiac rehabilitation. For the successful implementation of exercise-based cardiac rehabilitation programs, adequate cognitive function (e.g. executive function, selective attention, memory) is an important prerequisite. In patients with atherosclerotic coronary artery disease, the presence of coronary microvascular dysfunction as determined by low coronary flow reserve is associated with abnormal cerebral flow hemodynamics and mild but significant impairment in cognitive function. In the literature, there is no study examining the relationship between cognitive level and fatigue perception.
- Conditions
- Coronary Artery Disease
- Keywords
- Exercise Test, Fatigue, Cognitive Function
- Medical subject headings
- Coronary Artery Disease, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Coronary Artery Disease | Having been diagnosed with coronary artery disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive State Assessment
Montreal Cognitive Assessment Scale (MoCA) will be used to assess cognitive status.
Measured: August 2023-August 2024
Assessment of Exercise Capacity
Exercise capacity will be evaluated with modified shuttle walking test.
Measured: August 2023-August 2024
Assessment of Perceived Fatigue Severity After Exercise Test
It will be evaluated on the Modified Borg Scale from 0 to 10. 0 means no fatigue. 10 means extremely tired.
Measured: August 2023-August 2024
Secondary outcomes (1)
Physical Activity Assessment
Physical activity level will be measured with the International Physical Activity Questionnaire (IPAQ). 600 METs (Metabolic Equivalent of Task) min/week means inactive.
Measured: August 2023-August 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Sep 2023
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara Saklica, Hacettepe University
- Investigators
- Naciye Vardar-Yagli, PhD, Study director, Hacettepe UniversityHikmet Yorgun, PhD, Study chair, Hacettepe UniversityAhmet Hakan Ates, PhD, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246201
- Sponsor's protocol ID
- GO 23/639
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of The Relationship Between Cognitive Status and Exercise Capacity, Fatigue Perception in Coronary Artery Patients
- ClinicalTrials.gov ID
- NCT06246201
- Acronym / sponsor ID
- GO 23/639
- Conditions
- Coronary Artery Disease
- Keywords
- Exercise Test, Fatigue, Cognitive Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 7 Feb 2024 (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.
The study aimed to examine the relationship between cognitive status, exercise capacity, and fatigue perception in coronary artery disease patients.
Detailed description
Exercise training for patients with coronary artery disease is an essential element of multicomponent cardiac rehabilitation. For the successful implementation of exercise-based cardiac rehabilitation programs, adequate cognitive function (e.g. executive function, selective attention, memory) is an important prerequisite. In patients with atherosclerotic coronary artery disease, the presence of coronary microvascular dysfunction as determined by low coronary flow reserve is associated with abnormal cerebral flow hemodynamics and mild but significant impairment in cognitive function. In the literature, there is no study examining the relationship between cognitive level and fatigue perception.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Coronary Artery Disease | – | –Having been diagnosed with coronary artery disease |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are 18 years old and older and are diagnosed with coronary artery disease.
Key inclusion criteria (4 listed)
- Volunteering to participate in the research
- Being diagnosed with coronary artery disease
- To cooperate with the tests to be performed
- Signing a consent form
Key exclusion criteria (8 listed)
- Presence of neurological disease that may affect cognitive status
- Presence of clinically unstable cardiac disease
- Left ventricular ejection fraction <30%
- Being diagnosed with end-stage renal failure
- Diagnosed with active myocarditis or pericarditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive State Assessment
Time frame: August 2023-August 2024
Montreal Cognitive Assessment Scale (MoCA) will be used to assess cognitive status.
Assessment of Exercise Capacity
Time frame: August 2023-August 2024
Exercise capacity will be evaluated with modified shuttle walking test.
Assessment of Perceived Fatigue Severity After Exercise Test
Time frame: August 2023-August 2024
It will be evaluated on the Modified Borg Scale from 0 to 10. 0 means no fatigue. 10 means extremely tired.
1 secondary outcome
Physical Activity Assessment
Time frame: August 2023-August 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
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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.
Naciye Vardar-Yagli, PhD study director
Hacettepe University
Hikmet Yorgun, PhD study chair
Hacettepe University
Ahmet Hakan Ates, PhD study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cognitive State Assessment (time frame: August 2023-August 2024). The study lists 3 primary outcomes in all. 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 26 Feb 2024.