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

NCT05051774 | Suspended

• 1 other identifier: CREC Ref.No.:2020.678 -T
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Keywords

Coronary heart disease; Physical activity level; Exercise self-efficacy

Outcome Measures

Primary Outcomes (1)

• Change in physical activity level

  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

  Change from baseline physical activity level at 3 months.

Secondary Outcomes (10)

• Change in cardiac exercise self-efficacy score

  Change from baseline cardiac exercise self-efficacy score at 3 months.

• Change in Body mass index (BMI)

  Change from baseline body mass index 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 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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

In addition to usual care, the intervention group will receive the 12 weeks intervention consists of three monthly group education and center-based group exercise followed by 20 minutes of individualized telephone follow-up at weeks 3, 7, and 11.

Behavioral: 1. Education; Behavioral: 2. Exercise; Behavioral: 3. Telephone follow-up

Control Group

NO INTERVENTION

The control group will receive the usual care provided in the study hospital included an unstructured health education conducted by a nurse on healthy lifestyle and health assessment and brief unstructured health education on their conditions, focusing on the risk factors management and stress management by the cardiologist.

Interventions

1. Education BEHAVIORAL

Three monthly face-to-face group education with 8 to10 participants using a validated educational booklet will be provided by the researcher at the study hospital.

Intervention Group

2. Exercise BEHAVIORAL

The exercise intervention comprised of two elements as follows: 1. Three monthly hospital-based supervised group exercise consists of 8 to 10 participants. First two sessions: warm-up exercise-5 minutes, brisk walking-20 minutes at low intensity with music, and cool-down exercise-5 minutes. Third session: brisk walking for 30 minutes at moderate intensity with music. 2. Twelve-weeks home-based exercise: The participants will be asked to continue the exercise performed in the previous week at the hospital with music at least five times per week.

Intervention Group

3. Telephone follow-up BEHAVIORAL

A 20-minutes telephone follow-up at weeks 3, 7, and 11 for strengthening the volition of the participant to perform the exercise and follow the healthy diet at home.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karthikesu Karthijekan: lead
• Chinese University of Hong Kong: collaborator

Study Sites (1)

Teaching Hospital Batticaloa, Sri Lanka

Batticaloa, Eastern Province, 30000, Sri Lanka

Location

Related Publications (1)

• 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.

  PMID: 35788765 DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Ho Yu Cheng, PhD

  Chinese University of Hong Kong

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants and outcomes assessors only will be blinded in this study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A single-blind parallel randomized control trial

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 21, 2021
• Study Start: August 15, 2021
• Primary Completion: July 15, 2024
• Study Completion: November 15, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SR (1)