Clinical trial NCT05051774: Effectiveness of a Motivated, Action-based Intervention on Health Outcomes of Coronary Heart Disease Patients
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Coronary Heart Disease
Keywords: Coronary heart disease
Physical activity level
Exercise self-efficacy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
First posted: 2021-09-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-blind parallel randomized control trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

The eligibilities of participants are;

* Adults aged 18 years or above;
* Patients admitted to hospital with CHD for the first time confirmed by electrocardiogram;
* Patients able to reads and speak Tamil;
* Patients able to attend clinic follow-up, and obtain a medical clearance from a cardiologist to perform the exercise. The medical records of the CHD patients will be reviewed to screen for their eligibility. In addition, the cardiologist and physiotherapist at the study hospital will be consulted for confirming the suitability of the participants to perform the exercise of the intervention.

Exclusion Criteria:

The exclusion criteria are;

* Patients with absolute and relative contradictions to perform the exercise or at high risk for exercise, namely rest ejection fraction less than 40%, history of cardiac arrest, complex dysrhythmias at rest or during exercise testing or recovery, complicated myocardial infarction, high level of silent ischemia during exercise testing or recovery, presence of abnormal hemodynamics with exercise testing or recovery and presence of angina or other significant symptoms according to the American College of Sports Medicine (ACSM) guideline and American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) guideline (American College of Sports Medicine \[ACSM\], 2014);
* Patients with any diagnosis of life-threatening conditions;
* Patients with the psychotic disease;
* Patients who unable to perform physical activity independently.

Primary outcomes:
measure: Change in physical activity level
timeFrame: Change from baseline physical activity level at 3 months.
Secondary outcomes:
measure: Change in cardiac exercise self-efficacy score
timeFrame: Change from baseline cardiac exercise self-efficacy score at 3 months.
measure: Change in Body mass index (BMI)
timeFrame: Change from baseline body mass index at 3 months.
measure: Change in both Systolic Blood Pressure and Diastolic Blood Pressure
timeFrame: Change from baseline Systolic Blood Pressure and Diastolic Blood Pressure at 3 months.
measure: Change in Fasting Blood Glucose (FBG) level
timeFrame: Change from baseline Fasting Blood Glucose level at 3 months.
measure: Change in Waist hip ratio (WHR)
timeFrame: Change from baseline Waist hip ratio at 3 months.
measure: Change in total cholesterol level
timeFrame: Change from baseline total cholesterol level at 3 months.
measure: Change in high-density lipoprotein level
timeFrame: Change from baseline high-density lipoprotein level at 3 months.
measure: Change in low-density lipoprotein level
timeFrame: Change from baseline low-density lipoprotein level at 3 months.
measure: Change in triglyceride level
timeFrame: Change from baseline triglyceride level at 3 months.
measure: Change in total cholesterol high-density lipoprotein ratio
timeFrame: Change from baseline total cholesterol high-density lipoprotein ratio at 3 months.
Other outcomes:
Locations:
city: Batticaloa
country: Sri Lanka
facility: Teaching Hospital Batticaloa, Sri Lanka
state: Eastern Province
Study officials:
affiliation: Chinese University of Hong Kong
name: Ho Yu Cheng, PhD
role: STUDY_CHAIR
References:
citation: Karthijekan K, Cheng HY. 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. PLoS One. 2022 Jul 5;17(7):e0270800. doi: 10.1371/journal.pone.0270800. eCollection 2022.