NCT05051774

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

Suspended NA Last updated 13 September 2023

What this trial tests

NA trial testing 1. Education in Coronary Heart Disease in 150 participants. Suspended.

Timeline

15 August 2021

Primary endpoint
15 July 2024

15 November 2024

Quick facts

Lead sponsor	Karthikesu Karthijekan
Phase	NA
Status	Suspended
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	150
Start date	15 August 2021
Primary completion	15 July 2024
Estimated completion	15 November 2024
Sites	1 location across Sri Lanka

Drugs / interventions tested

• 1. Education
• 2. Exercise
• 3. Telephone follow-up

Conditions studied

• Coronary Heart Disease — all drugs for Coronary Heart Disease →

Sponsor

Karthikesu Karthijekan

Who can join

18 and older, any sex, with Coronary Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effectiveness of a motivated, action-based intervention on improving physical activity level, exercise self-efficacy and cardiovascular risk factors of patients with coronary heart disease in Sri Lanka: A randomized controlled trial protocol.
   Karthijekan K, Cheng HY. · · 2022 · cited 1× · PMID 35788765 · DOI 10.1371/journal.pone.0270800