Adherence, TreatmentNCT06364683
Coronary Artery Disease and Exercise Adherence
An observational study of Adherence, Treatment and Coronary Artery Disease, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Adherence, Treatment, Coronary Artery Disease
- What is being tested?
- Survey study
- How many people
- 208 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 May 2024to 13 May 2025
- 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 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population refers to adults with coronary artery disease.
Who may be able to join
- 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.
Who cannot join
- Presence of serious physical and mental health problems,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Exercise Adherence, Self-Efficacy, and Health Literacy in Patients With Coronary Artery Disease: A Descriptive Correlational Study
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.
Read the detailed description
Coronary Artery Disease (CAD) is the most common form of cardiovascular disease in the world and is one of the leading causes of mortality and morbidity in Turkey and worldwide. Exercise training is very important in the treatment of CAD because of its various cardiovascular benefits. However, most patients have been shown to have low to moderate adherence rates to the recommended exercise prescription. The results of a limited number of studies show that the factors affecting exercise adherence in patients with CAD need to be supported by new studies. This study aims to determine the factors affecting exercise adherence in patients with coronary artery disease (CAD). The study will be conducted with CAD patients followed up in the cardiology clinics of a tertiary care hospital in northern Turkey. A cohen's d will be calculated using preliminary data from 20 patients using Exercise Adherence Rating Scale (EARS), and an adequate sample size will be determined with a 95% confidence interval, a bias level of 0.05, and 80% power. Patients with a diagnosis of CAD confirmed by a physician at least one year ago, who have been recommended any exercise/physical activity by a physician according to article 1 of EARS, who are ≥18 years old and <75 years old, and who have the ability to understand and speak Turkish will be included in the study. The data will be collected using the following measurement tools 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.
- Conditions
- Adherence, Treatment, Coronary Artery Disease
- Being tested
- Survey study
- Keywords
- exercise adherence, coronary artery disease, self-efficacy, health literacy
- Medical subject headings
- Treatment Adherence and Compliance, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey studyOther
The data collection tools to be used in the study will be filled. It does not include any invasive or non-invasive intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start13 May 2024
- Primary completion13 Nov 2024
- Study completion13 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence, TreatmentStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 208 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyma Demir, Abant Izzet Baysal University
- Investigators
- Şeyma Demir Erbaş, PhD, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364683
- Sponsor's protocol ID
- AIBU-HSF-SDEMIR-04
- Status last verified
- Jul 2025
- First submitted
- 10 Apr 2024
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Exercise Adherence, Self-Efficacy, and Health Literacy in Patients With Coronary Artery Disease: A Descriptive Correlational Study
- ClinicalTrials.gov ID
- NCT06364683
- Acronym / sponsor ID
- AIBU-HSF-SDEMIR-04
- Conditions
- Adherence, Treatment, Coronary Artery Disease
- Keywords
- exercise adherence, coronary artery disease, self-efficacy, health literacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 13 May 2024 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 13 May 2025 (actual)
- First posted
- 15 Apr 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.
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.
Detailed description
Coronary Artery Disease (CAD) is the most common form of cardiovascular disease in the world and is one of the leading causes of mortality and morbidity in Turkey and worldwide. Exercise training is very important in the treatment of CAD because of its various cardiovascular benefits. However, most patients have been shown to have low to moderate adherence rates to the recommended exercise prescription. The results of a limited number of studies show that the factors affecting exercise adherence in patients with CAD need to be supported by new studies. This study aims to determine the factors affecting exercise adherence in patients with coronary artery disease (CAD). The study will be conducted with CAD patients followed up in the cardiology clinics of a tertiary care hospital in northern Turkey. A cohen's d will be calculated using preliminary data from 20 patients using Exercise Adherence Rating Scale (EARS), and an adequate sample size will be determined with a 95% confidence interval, a bias level of 0.05, and 80% power. Patients with a diagnosis of CAD confirmed by a physician at least one year ago, who have been recommended any exercise/physical activity by a physician according to article 1 of EARS, who are ≥18 years old and <75 years old, and who have the ability to understand and speak Turkish will be included in the study. The data will be collected using the following measurement tools 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population refers to adults with coronary artery disease.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Presence of serious physical and mental health problems,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey studyThe data collection tools to be used in the study will be filled. It does not include any invasive or non-invasive intervention. | Other | – |
Primary outcome
exercise adherence
Time frame: Baseline
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.
predictors for exercise adherence
Time frame: Baseline
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.
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 22 Jul 2025.
- Individual participant dataSharing planned: No. 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.
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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.
Şeyma Demir Erbaş, PhD principal investigator
Abant Izzet Baysal 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 Adherence, Treatment and Coronary Artery Disease, run by Abant Izzet Baysal 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 3 inclusion and 1 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 22 Jul 2025. 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?
exercise adherence (time frame: Baseline). The study lists 2 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 22 Jul 2025.