Coronary Heart DiseaseNCT05051774
Effectiveness of a Motivated, Action-based Intervention on Health Outcomes of Coronary Heart Disease Patients
A study testing 1. Education, 2. Exercise and 3. Telephone follow-up in people with Coronary Heart Disease, run by Karthikesu Karthijekan at 1 site in Sri Lanka.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- 1. Education, 2. Exercise and 3. Telephone follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSri Lanka
- Study dates
- 15 Aug 2021to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sri Lanka1 site
Teaching Hospital Batticaloa, Sri Lanka
Batticaloa, Eastern Province, 30000
About this study
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
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.
Read more
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
- Being tested
- 1. Education, 2. Exercise, 3. Telephone follow-up
- Keywords
- Coronary heart disease, Physical activity level, Exercise self-efficacy
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. EducationBehavioural
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.
2. ExerciseBehavioural
The exercise intervention comprised of two elements as follows:
- 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.
- 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.
3. Telephone follow-upBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline physical activity level at 3 months.
Secondary outcomes (10)
Change in cardiac exercise self-efficacy score
It will be measured using validated Tamil version of Cardiac Exercise Self-Efficacy Instrument (CESEI-T).The CESEI-T is a 16-item instrument to assess the individual's confidence to perform physical exercise in cardiac patients. Each item is rated on a five-point Likert scale from 1 (very little confidence) to 5 (quite a lot of confidence). Participants will be asked to rate their confidence level in performing exercise in various situations such as "fitting exercise into a busy day," "exercising without getting chest pain," "taking own heart rate before and after exercise," and "enduring light exercise". The CESEI-T score range from 16-80 and a higher score indicates that a high level of self-efficacy in performing the exercise.
Measured: Change from baseline cardiac exercise self-efficacy score at 3 months.
Change in Body mass index (BMI)
All anthropometric measurements will be performed by a trained research assistant who will be blinded to the group allocation of participants. The weight will be measured with a calibrated mechanical personal scale. Participants will be weighed wearing light clothes, without shoes, and an empty bladder. The height will be measured in a standing position by using a plastic flexible tape (without shoes) and BMI will be calculated as weight in kilograms divided by height squared in meters (kg/m2).
Measured: Change from baseline body mass index at 3 months.
Change in both Systolic Blood Pressure and Diastolic Blood Pressure
Blood pressure in a sitting position will be measured using a mercury sphygmomanometer (Dekamevit model Code: AC0125). Participants will be asked to rest for 15 minutes and no caffeinated food or drink 30 minutes before the blood pressure measurement.
Measured: Change from baseline Systolic Blood Pressure and Diastolic Blood Pressure at 3 months.
Change in Fasting Blood Glucose (FBG) level
The participants' FBG level will be obtained from their clinical records.
Measured: Change from baseline Fasting Blood Glucose level at 3 months.
Change in Waist hip ratio (WHR)
Waist circumference (WC) will be measured using a non-stretchable measuring tape at the approximate midpoint between the lower margin of the last palpable rib and the top of the iliac crest to the nearest 1cm, at end of the normal expiration. Hip circumference (HC) will be measured at the widest level over the grater trochanters using plastic flexible tape to the nearest 0.1 cm. WHR will be estimated as waist measurement (cm) divided by hip measurement (cm).
Measured: Change from baseline Waist hip ratio at 3 months.
Change in total cholesterol level
The participants' total cholesterol level will be obtained from their clinical records.
Measured: Change from baseline total cholesterol level at 3 months.
Change in high-density lipoprotein level
The participants' high-density lipoprotein level will be obtained from their clinical records.
Measured: Change from baseline high-density lipoprotein level at 3 months.
Change in low-density lipoprotein level
The participants' low-density lipoprotein level will be obtained from their clinical records.
Measured: Change from baseline low-density lipoprotein level at 3 months.
Change in triglyceride level
The participants' triglyceride level will be obtained from their clinical records.
Measured: Change from baseline triglyceride level at 3 months.
Change in total cholesterol high-density lipoprotein ratio
The participants' total cholesterol high-density lipoprotein ratio will be obtained from their clinical records.
Measured: Change from baseline total cholesterol high-density lipoprotein ratio at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start15 Aug 2021
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Why it stopped: The study had been suspended last year due to COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-blind parallel randomized control trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karthikesu Karthijekan
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Sponsor-investigator, Karthikesu Karthijekan, Chinese University of Hong Kong
- Investigators
- Ho Yu Cheng, PhD, Study chair, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051774
- Sponsor's protocol ID
- CREC Ref.No.:2020.678 -T
- Status last verified
- Sep 2023
- First submitted
- 1 Sep 2021
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared with other researchers.
Publications
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.
PubMed 35788765
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05051774
- Acronym / sponsor ID
- CREC Ref.No.:2020.678 -T
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary heart disease, Physical activity level, Exercise self-efficacy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study had been suspended last year due to COVID-19 pandemic.
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Karthikesu KarthijekanUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A single-blind parallel randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: 1. Education, Behavioral: 2. Exercise, Behavioral: 3. Telephone follow-upIn 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1. EducationThree 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. | Behavioural | Intervention Group |
| 2. ExerciseThe 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. | Behavioural | Intervention Group |
| 3. Telephone follow-upA 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. | Behavioural | Intervention Group |
Primary outcome
Change in physical activity level
Time frame: 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
10 secondary outcomes
Change in cardiac exercise self-efficacy score
Time frame: Change from baseline cardiac exercise self-efficacy score at 3 months.
Change in Body mass index (BMI)
Time frame: Change from baseline body mass index at 3 months.
Change in both Systolic Blood Pressure and Diastolic Blood Pressure
Time frame: Change from baseline Systolic Blood Pressure and Diastolic Blood Pressure at 3 months.
Change in Fasting Blood Glucose (FBG) level
Time frame: Change from baseline Fasting Blood Glucose level at 3 months.
Change in Waist hip ratio (WHR)
Time frame: Change from baseline Waist hip ratio at 3 months.
Change in total cholesterol level
Time frame: Change from baseline total cholesterol level at 3 months.
Change in high-density lipoprotein level
Time frame: Change from baseline high-density lipoprotein level at 3 months.
Change in low-density lipoprotein level
Time frame: Change from baseline low-density lipoprotein level at 3 months.
Change in triglyceride level
Time frame: Change from baseline triglyceride level at 3 months.
Change in total cholesterol high-density lipoprotein ratio
Time frame: Change from baseline total cholesterol high-density lipoprotein ratio at 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 35788765Karthijekan 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.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho Yu Cheng, PhD study chair
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1. Education, 2. Exercise and 3. Telephone follow-up in people with Coronary Heart Disease, run by Karthikesu Karthijekan at 1 site in Sri Lanka.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity level (time frame: Change from baseline physical activity level at 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05051774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.