Effectiveness of a Motivated, Action-based Intervention on Health Outcomes of Coronary Heart Disease Patients

Coronary Heart Disease Clinical Trial

Official title: The Effectiveness of a Motivated, Action-based Intervention on Improving Physical Activity Level, Exercise Self-efficacy and Cardiovascular Risk Factors of Coronary Heart Disease Patients: A Randomized Controlled Trial

Status Suspended

Clinical Trial Summary

Coronary heart disease (CHD), the major group of cardiovascular disorders, is the leading cause of cardiac-associated mortality, causing >9 million death in 2016. American Heart Association (AHA) and the American College of Cardiology Foundation (ACCF) recognized that lifestyle modification including physical activity is the class one-level recommendation for secondary prevention and risk reduction therapy for patients with CHD. The assessment of physical activity and confidence in performing exercise for patients with CHD will help healthcare professionals to develop and implement the appropriate intervention to enhance patients' confidence in performing exercise and physical activity to promote and maintain their health.

With the increasing morbidity and mortality from CHD, especially in low and middle-income countries, secondary prevention including exercise-based cardiac rehabilitation (CR) plays an important role to improve the prognosis of CHD patients. High prevalence of physical inactivity, unhealthy dietary practices, poor control of blood glucose, blood pressure (BP), blood lipid, and body weight (BW) was found among CHD patients in the world as well as in Sri Lanka. Therefore, it is important to design and implement an appropriate intervention to improve the physical activity level, exercise self-efficacy, and cardiovascular risk factors in CHD patients in Sri Lanka. This study aims to develop and examine a culturally specific motivated, action-based intervention for improving physical activity level, exercise self-efficacy, and cardiovascular risk factors of CHD patients in Sri Lanka.

The participants will be patients who admitted to the coronary care unit (CCU) and medical wards of the Teaching Hospital Batticaloa, Sri Lanka with CHD for the first time confirmed by electrocardiogram with aged 18 years or above, able to reads and speak Tamil, able to attend clinic follow-up, obtain a medical clearance from a cardiologist to perform the exercise and, able to understand and give informed consent. The medical records of the CHD patients will be reviewed to screen for their eligibility. In addition, the cardiologist of the participants will be consulted for their suitability to perform the exercise of the intervention.

The purpose of the study, the data collection procedures, the potential risk and benefits, the maintenance of confidentiality, and the voluntary basis of participation will be clearly explained to the participants, and informed written consent will be obtained before data collection. Ethical approval was obtained from The Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee and Ethics Review Committee, Faculty of Health Care-sciences, Eastern University, Sri Lanka.

The Statistical Package for Social Science version 22.0 software (SPSS 22.0) will be used to analyze the data and the p-value less than 0.5 will be considered as significant.

This study will provide evidence on the effectiveness of a motivated, action-based intervention on the physical activity level, cardiovascular risk factors, and exercise self-efficacy of CHD patients in Sri Lanka. Findings from this study could be useful to promote healthy lifestyle behaviors in CHD patients in a low-resource setting. Furthermore, this study will provide information on which level this intervention could be applied and possible constraints that hinder the outcomes of the results.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

• NCT number: NCT05051774
• Study type: Interventional
• Source: Chinese University of Hong Kong
• Status: Suspended
• Phase: N/A
• Start date: August 15, 2021
• Completion date: November 15, 2024