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
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in physical activity level
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participants and outcomes assessors only will be blinded in this study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in physical activity level
时间窗: Change from baseline physical activity level at 3 months.
The validated Tamil version of International Physical Activity Questionnaire Short Form (IPAQ-SF) will be used to assess the self-reported time spent in walking, moderate and vigorous-intensity activities, and sitting in this study
次要结局
- Change in cardiac exercise self-efficacy score(Change from baseline cardiac exercise self-efficacy score at 3 months.)
- Change in Fasting Blood Glucose (FBG) level(Change from baseline Fasting Blood Glucose level at 3 months.)
- Change in Waist hip ratio (WHR)(Change from baseline Waist hip ratio at 3 months.)
- Change in both Systolic Blood Pressure and Diastolic Blood Pressure(Change from baseline Systolic Blood Pressure and Diastolic Blood Pressure at 3 months.)
- Change in high-density lipoprotein level(Change from baseline high-density lipoprotein level at 3 months.)
- Change in triglyceride level(Change from baseline triglyceride level at 3 months.)
- Change in Body mass index (BMI)(Change from baseline body mass index at 3 months.)
- Change in total cholesterol level(Change from baseline total cholesterol level at 3 months.)
- Change in total cholesterol high-density lipoprotein ratio(Change from baseline total cholesterol high-density lipoprotein ratio at 3 months.)
- Change in low-density lipoprotein level(Change from baseline low-density lipoprotein level at 3 months.)
研究者
Karthikesu Karthijekan
Principal Investigator
Chinese University of Hong Kong