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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06246201
Other study ID # GO 23/639
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date February 23, 2024

Study information

Verified date February 2024
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The study aimed to examine the relationship between cognitive status, exercise capacity, and fatigue perception in coronary artery disease patients.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 23, 2024
Est. primary completion date February 23, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cognitive State Assessment Montreal Cognitive Assessment Scale (MoCA) will be used to assess cognitive status. August 2023-August 2024
Primary Assessment of Exercise Capacity Exercise capacity will be evaluated with modified shuttle walking test. August 2023-August 2024
Primary 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. August 2023-August 2024
Secondary 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. August 2023-August 2024
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