NCT06246201

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2024

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

January 30, 2024

Last Update Submit

February 23, 2024

Conditions

Keywords

Exercise TestFatigueCognitive Function

Outcome Measures

Primary Outcomes (3)

  • Cognitive State Assessment

    Montreal Cognitive Assessment Scale (MoCA) will be used to assess cognitive status.

    August 2023-August 2024

  • Assessment of Exercise Capacity

    Exercise capacity will be evaluated with modified shuttle walking test.

    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.

    August 2023-August 2024

Secondary Outcomes (1)

  • Physical Activity Assessment

    August 2023-August 2024

Study Arms (1)

Patients with Coronary Artery Disease

Having been diagnosed with coronary artery disease

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients are 18 years old and older and are diagnosed with coronary artery disease.

You may qualify if:

  • Volunteering to participate in the research
  • Being diagnosed with coronary artery disease
  • To cooperate with the tests to be performed
  • Signing a consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery DiseaseFatigue

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Naciye Vardar-Yagli, PhD

    Hacettepe University

    STUDY DIRECTOR
  • Hikmet Yorgun, PhD

    Hacettepe University

    STUDY CHAIR
  • Ahmet Hakan Ates, PhD

    Hacettepe University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 7, 2024

Study Start

September 1, 2023

Primary Completion

February 23, 2024

Study Completion

February 23, 2024

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations