- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06364683
Coronary Artery Disease and Exercise Adherence
April 10, 2024 updated by: Seyma Demir, Abant Izzet Baysal University
Determination of Factors Affecting Exercise Adherence in Patients With Coronary Artery Disease: a Descriptive Cross-sectional 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Halil İlker YENCİLEK, Chief Physician
- Phone Number: +90 374 253 46 26
- Email: bolueah1@saglik.gov.tr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
The study population refers to adults with coronary artery disease.
Description
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,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Şeyma Demir Erbaş, PhD, Abant Izzet Baysal University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 13, 2024
Primary Completion (Estimated)
November 13, 2024
Study Completion (Estimated)
May 13, 2025
Study Registration Dates
First Submitted
April 10, 2024
First Submitted That Met QC Criteria
April 10, 2024
First Posted (Estimated)
April 15, 2024
Study Record Updates
Last Update Posted (Estimated)
April 15, 2024
Last Update Submitted That Met QC Criteria
April 10, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-HSF-SDEMIR-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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