Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))NCT07130045
Hybrid Exercise Program for Heart Disease: Effect on Health and Quality of Life
A study testing Hybrid Endurance Strength Training in people with Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
- What is being tested?
- Hybrid Endurance Strength Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteMalaysia
- Study dates
- Oct 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Universiti Malaya Medical Center
Kuala Lumpur, Lembah Pantai, 59100
Anwar Suhaimi, +60166591383, anwar@ummc.edu.my
About this study
Official title: 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
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.
Read the detailed description
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.
- Being tested
- Hybrid Endurance Strength Training, Usual Care
- Keywords
- coronary artery disease, combined training, hybrid, cardiac rehabilitation
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Endurance Strength TrainingOther
Also called HyBEST
HybEST will be delivered three times weekly over eight weeks, with two supervised sessions at the center and 22 unsupervised sessions at home. The exercise characteristics of supervised HybEST and unsupervised HybEST are described. Monitoring methods for unsupervised HybEST include a wearable tracking device that collects data on patients' health parameters (arterial oxygen saturation (SpO2), heart rate, and blood pressure) and weekly phone calls. The unsupervised sessions will include video material on the home-based exercise program.
Usual CareOther
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Endurance and Strength Training (HybEST) | Experimental | 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. Receives: Other: Hybrid Endurance Strength Training |
| Usual Care (UC) | Active comparator | 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treadmill stress test
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.
Measured: Day 0, Week 9
Secondary outcomes (9)
Body composition
Body composition, including body mass index (BMI), body fat percentage, lean mass percentage, and weight in kilograms, will be measured using the bioimpedance meter (OMRON HBF-500INT). Participants' height (meters) will be recorded with the SECA stadiometer. To determine waist circumference, the midpoint between the front-back hip bone and the bottom rib border will be identified when the subject is upright. The average will be calculated by dividing the sum of the two measurements by two.
Measured: Day 0, Week 5, Week 9
Muscle strength
The strength of major muscles in the upper and lower limbs will be measured using a handheld dynamometer (HHD). A plinth-mounted seat and armrest are provided for the participant's positioning and restraint during HHD testing.
Measured: Day 0, Week 5, Week 9
Functional Capacity
The goal of the Six-Minute Walk Test (6MWT) is for participants to walk as far as they can at a comfortable pace. Every minute, patients will receive standardized encouragement such as "You are doing well" or "Keep up the good work," along with a reminder of the remaining time. Qualified personnel will walk behind the patient to supervise the test. During the test, patients are allowed to stop if necessary, but they will be advised to resume walking as soon as possible. Patients may use their walking aids during the test, and 6MWD will be recorded in meters. Heart rate (HR) and oxygen saturation (SpO2) will be measured before, during, and after the 6MWT using pulse oximetry (Model 2500, Nonin Medical, Inc., Minneapolis, MN, USA).
Measured: Day 0, Week 5, Week 9
Physical Activity
The International Physical Activity Questionnaire (IPAQ) will be used to assess the level of physical activity based on information about the time spent walking, participating in moderate-to-vigorous activities, and avoiding sedentary behavior during the previous seven days. According to participant responses, physical activity is categorized into three levels: moderate (600-3000 MET minutes/week), vigorous (more than 3000 MET minutes/week), and light (less than 600 MET minutes/week).
Measured: Day 0, Week 5, Week 9
Total Energy Expenditure
METs will be assessed using a treadmill stress test conducted according to standard protocols (e.g., Bruce or Modified Bruce). Participants will exercise until they reach volitional fatigue or achieve predetermined termination criteria based on clinical guidelines. The highest workload achieved, expressed in METs, will be calculated from the treadmill speed and grade at peak exercise.
Measured: Day 0, Week 5, Week 9
Health-related Quality of Life
The Medical Outcomes Study Short Form Health Survey (SF-36) will be used to evaluate a person's health status. The SF-36 questionnaire is a standardized tool with 36 items that measure eight different subscales, which cover various aspects of physical functioning, role functioning, physiological discomfort, general health, vitality, social functioning, role-emotional, and mental health. Both individual subscale scores and two summary scores, known as the physical component summary score (PCS) and mental component summary score (MCS), can be calculated.
Measured: Day 0, Week 9
Self-efficacy
The Self-efficacy to Exercise (SEE) questionnaire consists of nine items. The overall score is the sum of all answers to these questions, with total scores ranging from 0 to 90. A higher score indicates greater self-efficacy for exercising.
Measured: Day 0, Week 9
Barriers to participation
To identify barriers to CR participation, participants will complete a self-administered Cardiac Rehabilitation Barriers Scale (CRBS) questionnaire. It uses a 5-point Likert scale, from 1 (strongly disagree) to 5 (strongly agree), to rate the items. The CRBS includes four subscales: three items about job and time conflicts; five items on logistical issues such as cost, distance, and transportation; nine items concerning perceived needs and healthcare factors; and four related to comorbidities and functional status. Higher ratings indicate more obstacles to enrolling in a CR.
Measured: Day 0, Week 9
Participation and adherence rate
Participation and adherence rates will be documented through self-reflected forms and diaries. Participation rate is defined as the proportion of patients who accepted to participate out of those offered the program, expressed as a percentage. Adherence refers to the proportion of the 24 prescribed trainings attended. Patients attending more than 75% of the total training sessions are considered completers.
Measured: Day 0, Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))Studies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anwar Suhaimi, Principal investigator, Universiti Malaya Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130045
- Sponsor's protocol ID
- 2025116-14608
- Other IDs
- FRGS/1/2023/SS10/UITM/03/4
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07130045
- Acronym / sponsor ID
- 2025116-14608
- Keywords
- coronary artery disease, combined training, hybrid, cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Aug 2025 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid Endurance and Strength Training (HybEST) | Experimental | Other: Hybrid Endurance Strength TrainingHybEST will be delivered three times weekly over eight weeks; there will be two supervised sessions at the center and 22 unsupervised sessions at home. |
| Usual Care (UC) | Active comparator | Other: Usual CareThe UC group participants will participate in combined endurance and strength training similar to the intervention group's weekly center-based session over eight weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Hybrid Endurance Strength TrainingAlso: HyBESTHybEST will be delivered three times weekly over eight weeks, with two supervised sessions at the center and 22 unsupervised sessions at home. The exercise characteristics of supervised HybEST and unsupervised HybEST are described. Monitoring methods for unsupervised HybEST include a wearable tracking device that collects data on patients' health parameters (arterial oxygen saturation (SpO2), heart rate, and blood pressure) and weekly phone calls. The unsupervised sessions will include video material on the home-based exercise program. | Other | Hybrid Endurance and Strength Training (HybEST) |
| Usual CareAlso: UCThe UC group participants will participate in combined endurance and strength training similar to the intervention group's weekly center-based session over eight weeks. | Other | Usual Care (UC) |
Primary outcome
Treadmill stress test
Time frame: 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.
9 secondary outcomes
Body composition
Time frame: Day 0, Week 5, Week 9
Muscle strength
Time frame: Day 0, Week 5, Week 9
Functional Capacity
Time frame: Day 0, Week 5, Week 9
Physical Activity
Time frame: Day 0, Week 5, Week 9
Total Energy Expenditure
Time frame: Day 0, Week 5, Week 9
Health-related Quality of Life
Time frame: Day 0, Week 9
Self-efficacy
Time frame: Day 0, Week 9
Barriers to participation
Time frame: Day 0, Week 9
Participation and adherence rate
Time frame: Day 0, Week 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
Anwar Suhaimi principal investigator
Universiti Malaya Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Endurance Strength Training in people with Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), run by University of Malaya at 1 site in Malaysia.
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: opening soon, as of the sponsor's last update on 17 Apr 2026. 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 Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aliff Latir (+60183544770, aliff533@uitm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treadmill stress test (time frame: Day 0, Week 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2026.