Effect of Hybrid Endurance and Strength Training (HyBEST) on Health-Related Outcomes and Quality of Life in Patients With Coronary Artery Disease During Phase II Cardiac Rehabilitation Program
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Treadmill stress test
研究概览
简要总结
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.
详细描述
In recent years, models for delivering cardiac rehabilitation (CR) have advanced by incorporating structured exercise methods and technology into routine practice. Hybrid Endurance-Strength Training (HybEST) combines supervised center-based sessions with home-based elements, supported by digital tools such as remote monitoring and virtual consultations. This hybrid approach may help overcome common barriers to CR participation, including travel distance, scheduling conflicts, and work commitments. This single-centre, two-arm parallel randomized controlled trial aims to evaluate the effects of a hybrid exercise program in patients with coronary heart disease. The objectives are;
- To evaluate the effects of a hybrid exercise program on patients' body function and structures, including exercise capacity, body composition, and muscle strength, compared to usual care.
- To determine the effects of a hybrid exercise program on patients' activity, including functional capacity, physical activity, and total energy expenditure, compared to usual care.
- To assess the effects of a hybrid exercise program on patients' participation, specifically health-related quality of life, compared to usual care.
A total of 84 eligible participants (42 per group, accounting for 14% attrition) will be randomized into either the intervention or control group. The usual care group will follow a standard exercise program consisting of endurance and strength components. This program includes supervised exercise sessions at the center once a week for eight weeks, along with educational materials on exercising at home. The intervention group will participate in a hybrid training program that combines endurance and strength training over eight weeks. Their program includes two supervised sessions at the center and 22 unsupervised sessions at home. Participants will receive exercise educational videos via WhatsApp (Weeks 1-8) and a fitness tracker to support unsupervised sessions. Weekly virtual follow-ups will be conducted from Week 1 to Week 8. Outcome measures include Exercise Capacity, Body Composition, Muscle Strength, Physical Activity and METs, Barrier Scales, and Health-Related Quality of Life. Data will be analyzed using IBM SPSS version 26.0, with statistical significance set at p < 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Hybrid Endurance and Strength Training (HybEST)
HybEST will be delivered three times weekly over eight weeks; there will be two supervised sessions at the center and 22 unsupervised sessions at home.
干预措施: Hybrid Endurance Strength Training (Other)
Usual Care (UC)
The UC group participants will participate in combined endurance and strength training similar to the intervention group's weekly center-based session over eight weeks.
干预措施: Usual Care (Other)
结局指标
主要结局
Treadmill stress test
时间窗: Day 0, Week 9
A treadmill stress test will be used to assess the participant's exercise capacity. This type of stress testing is typically performed with the Bruce protocol on either a treadmill or an ergometer, monitored with electrocardiography (ECG) and blood pressure. The Bruce protocol requires participants to complete successive 3-minute stages, with each stage increasing in walking speed and incline. During the test, data on heart rate (HR), blood pressure (BP), and ECG changes will be recorded at the end of each stage. After testing, a report will be generated outlining (i) ECG interpretation and baseline HR and BP, (ii) exercise-induced changes in ECG, (iii) maximum heart rate and blood pressure during exercise, (iv) estimated exercise capacity in metabolic equivalents (METs), (v) exercise duration and stage completed, and (vi) symptoms experienced during exercise and reasons for test termination.
次要结局
- Body composition(Day 0, Week 5, Week 9)
- Muscle strength(Day 0, Week 5, Week 9)
- Functional Capacity(Day 0, Week 5, Week 9)
- Physical Activity(Day 0, Week 5, Week 9)
- Total Energy Expenditure(Day 0, Week 5, Week 9)
- Health-related Quality of Life(Day 0, Week 9)
- Self-efficacy(Day 0, Week 9)
- Barriers to participation(Day 0, Week 9)
- Participation and adherence rate(Day 0, Week 9)