NCT06364683

Brief Summary

This study aims to determine the factors affecting exercise adherence in patients with coronary artery disease (CAD). For this purpose, the following measurement tools will be used respectively: (1) "Patient Information Form" including sociodemographic characteristics of the patients and medical information related to the disease, (2) the Exercise Adherence Rating Scale (EARS), (3) Exercise Self-Efficacy Scale (ESE) and, (4) Turkish-Health Literacy Survey Europe-Q12 (HLS-EU-19-12Q-TR). Statistical analyses will be carried out by descriptive statistics (number, percentage, mean, standard deviation, etc.), correlation analysis and regression analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

May 13, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2025

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

April 10, 2024

Last Update Submit

July 17, 2025

Conditions

Keywords

exercise adherencecoronary artery diseaseself-efficacyhealth literacy

Outcome Measures

Primary Outcomes (2)

  • exercise adherence

    EARS, a self-report measurement tool, was developed to assess adherence to prescribed home exercise regimes. It has three sections, A (qualitative information about participants' exercise adherence behaviours), B (exercise adherence behaviours) and C (factors preventing and facilitating exercise). Sections B and C are scored using a 5-point Likert scale (0=totally agree to 4=totally disagree).The total scores of Parts B and C range from 0 to 24 and 0 to 40, respectively, and the possible total scores (Part B + Part C) range from 0 to 64. A higher total score from the EARS indicates better exercise adherence. Cronbach's alpha coefficient was found to be 0.81 in the original scale and 0.86 in the Turkish version.

    Baseline

  • predictors for exercise adherence

    The following instruments will be used to measure predictors for exercise adherence: (1) patient information form, (2) ESE and, (3) HLS-EU-19-12Q-TR. The patient information form includes 14 items including sociodemographic characteristics and medical information related to the disease. The ESE has 18 items. Scores between 0-100% are obtained from the scale, the higher the score, the higher the self-efficacy level of the participants. Cronbach's alpha coefficient is 0.94. The HLS-EU-19-12Q-TR has 12 items. The total score is calculated with a standardised index score (Index=\[mean-1\]\*\[50/3\]). The standardised index score varies between 0-50. A score of 33 and over indicates adequate literacy. Correlation analyses and regression modelling will be used for the factors affecting participants' exercise adherence.

    Baseline

Interventions

The data collection tools to be used in the study will be filled. It does not include any invasive or non-invasive intervention.

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population refers to adults with coronary artery disease.

You may qualify if:

  • A diagnosis of CAD confirmed by a physician at least one year ago,
  • Individuals who have been recommended any exercise/physical activity by a physician according to item 1 of the EARS,
  • Turkish comprehension and speaking skills.

You may not qualify if:

  • Presence of serious physical and mental health problems,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şeyma Demir Erbaş

Bolu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Treatment Adherence and ComplianceCoronary Artery Disease

Interventions

Longitudinal Studies

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Cohort StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Şeyma Demir Erbaş, PhD

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 10, 2024

First Posted

April 15, 2024

Study Start

May 13, 2024

Primary Completion

November 13, 2024

Study Completion

May 13, 2025

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Participant data will not be shared openly with other researchers due to the confidentiality of personal data. The primary investigator of the study can be contacted for data sharing.

Locations