Hybrid Exercise Program for Heart Disease: Effect on Health and Quality of Life (NCT07130045) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Hybrid Exercise Program for Heart Disease: Effect on Health and Quality of Life
Malaysia84 participantsStarted 2026-10
Plain-language summary
Cardiac rehabilitation (CR) participation remains suboptimal, partly due to logistical challenges and limited access to center-based programs. Hybrid Endurance-Strength Training (HybEST) offers an alternative model by combining supervised endurance and strength exercises with home-based components. The main questions it aims to answer are:
* Does a hybrid exercise program significantly improve a patient's body function and structures \[exercise capacity, body composition, and muscle strength\] compared to usual care?
* Does a hybrid exercise program significantly improve a patient's activity \[functional capacity, physical activity, and total energy expenditure\] compared to usual care?
* Does a hybrid exercise program significantly improve a patient's participation \[health-related quality of life\] compared to usual care?
This single-center, two-arm parallel randomized clinical trial aims to evaluate the effects of HybEST on health-related outcomes and quality of life among patients with coronary artery disease in Phase II CR. Eligible participants will be randomly assigned in a 1:1 ratio to either the HybEST intervention group or the standard CR control group using a lottery method, specifically the sealed envelope approach. Assessments will be conducted at baseline (T0), Week 5 (T2), and Week 9 (T3) to measure changes in health-related outcomes and quality of life.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age of 18 years or older.
* Diagnosed with coronary artery disease (CAD), with or without invasive treatment, maintaining a normal sinus rhythm and preserved left ventricular ejection fraction (LVEF).
* In a stable clinical condition.
* capable of regularly attending a supervised exercise program.
* Able to complete questionnaires in English or Malay.
Exclusion Criteria:
* They exhibited abnormal responses during the initial exercise test, such as irregular haemodynamic responses, ST segment depression greater than 2 mm, or any ventricular fibrillation.
* Their forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) is less than 50% of the predicted value.
* They cannot participate in exercise testing due to non-cardiac limitations.
* They have been hospitalized due to heart failure within the past year.
* They have uncontrollable hypertension.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.