- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06246201
The Relationship Between Cognitive Status and Exercise Capacity, Fatigue Perception in Coronary Artery Patients
February 23, 2024 updated by: Dilara Saklica, Hacettepe University
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey
- HACETTEPE UNIVERSİTY
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients are 18 years old and older and are diagnosed with coronary artery disease.
Description
Inclusion Criteria:
- Volunteering to participate in the research
- Being diagnosed with coronary artery disease
- To cooperate with the tests to be performed
- Signing a consent form
Exclusion Criteria:
- 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
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 |
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Patients with Coronary Artery Disease
Having been diagnosed with coronary artery disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive State Assessment
Time Frame: August 2023-August 2024
|
Montreal Cognitive Assessment Scale (MoCA) will be used to assess cognitive status.
|
August 2023-August 2024
|
Assessment of Exercise Capacity
Time Frame: August 2023-August 2024
|
Exercise capacity will be evaluated with modified shuttle walking test.
|
August 2023-August 2024
|
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.
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August 2023-August 2024
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity Assessment
Time Frame: August 2023-August 2024
|
Physical activity level will be measured with the International Physical Activity Questionnaire (IPAQ).
600 METs (Metabolic Equivalent of Task) min/week means inactive.
|
August 2023-August 2024
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Naciye Vardar-Yagli, PhD, HACETTEPE UNIVERSİTY
- Study Chair: Ahmet Hakan Ates, PhD, HACETTEPE UNIVERSİTY
- Study Chair: Hikmet Yorgun, PhD, HACETTEPE UNIVERSİTY
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 (Actual)
September 1, 2023
Primary Completion (Actual)
February 23, 2024
Study Completion (Actual)
February 23, 2024
Study Registration Dates
First Submitted
January 30, 2024
First Submitted That Met QC Criteria
January 30, 2024
First Posted (Actual)
February 7, 2024
Study Record Updates
Last Update Posted (Actual)
February 26, 2024
Last Update Submitted That Met QC Criteria
February 23, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 23/639
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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