Hybrid Exercise Program for Heart Disease: Effect on Health and Quality of Life

NCT07130045 | Not Yet Recruiting

• 2 other identifiers: 2025116-14608FRGS/1/2023/SS10/UITM/03/4
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))

Keywords

coronary artery disease; combined training; hybrid; cardiac rehabilitation

Outcome Measures

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.

  Day 0, Week 9

Secondary Outcomes (9)

• 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

Study Arms (2)

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.

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.

Other: Usual Care

Interventions

Hybrid Endurance Strength Training OTHER

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.

Also known as: HyBEST

Hybrid Endurance and Strength Training (HybEST)

Usual Care OTHER

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.

Also known as: UC

Usual Care (UC)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Universiti Malaya Medical Center

Kuala Lumpur, Lembah Pantai, 59100, Malaysia

Location

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Anwar Suhaimi

  Universiti Malaya Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aliff Latir

CONTACT

+60183544770; aliff533@uitm.edu.my

Anwar Suhaimi

CONTACT

+60166591383; anwar@ummc.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 19, 2025
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 2 months and ending 2 years after the publication of results
• Access Criteria: Individual participant data (IPD) underlying published results will be shared with qualified researchers whose analyses aim to advance cardiac rehabilitation science. Requests must include a research proposal detailing objectives, planned analyses, and statistical methods, which may require independent review. Approved applicants must sign a data-sharing agreement. Requests should be submitted to the principal investigator via email. Proposals will be reviewed by a data access committee based on scientific merit, ethical compliance, and consistency with participant consent.

Locations

MY (1)