Hybrid Exercise Program for Heart Disease: Effect on Health and Quality of Life
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Malaya
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Hybrid Endurance Strength Training
Other interventionHybEST 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 Care
Other interventionThe UC group participants will participate in combined endurance and strength training similar to the intervention group's weekly center-based session over eight weeks.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Hybrid Endurance and Strength Training (HybEST)Experimental treatment 1 intervention
Group B: Usual Care (UC)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 0, Week 9Secondary outcomes
1
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.
Time frame
Day 0, Week 5, Week 92
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.
Time frame
Day 0, Week 5, Week 93
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).
Time frame
Day 0, Week 5, Week 94
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).
Time frame
Day 0, Week 5, Week 9Sponsors and contacts
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Source ClinicalTrials.gov
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