Ignite Creation Date:
2024-05-06 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05051774
Status:
SUSPENDED
Last Update Posted:
2023-09-13
First Post:
2021-09-01
Brief Title:
Effectiveness of a Motivated Action-based Intervention on Health Outcomes of Coronary Heart Disease Patients
Sponsor:
Karthikesu Karthijekan
Organization:
Chinese University of Hong Kong
Study Overview
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
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study had been suspended last year due to COVID-19 pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 220 software SPSS 220 will be used to analyze the data and the p-value less than 05 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
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 220 software SPSS 220 will be used to analyze the data and the p-value less than 05 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None