Coronary Artery Disease and Exercise Adherence

Coronary Artery Disease Clinical Trial

Official title:

Determination of Factors Affecting Exercise Adherence in Patients With Coronary Artery Disease: a Descriptive Cross-sectional Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06364683
• Other study ID #: AIBU-HSF-SDEMIR-04
• Status: Not yet recruiting
• Start date: May 13, 2024
• Est. completion date: May 13, 2025

Study information

• Verified date: April 2024
• Source: Abant Izzet Baysal University
• Contact: Halil Ilker YENCILEK, Chief Physician
• Phone: +90 374 253 46 26
• Email: bolueah1[@]saglik.gov.tr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: May 13, 2025
• Est. primary completion date: November 13, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Presence of serious physical and mental health problems,

Related Conditions & MeSH terms

• Adherence, Treatment
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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