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

NCT07130045 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-04-17

No results posted yet for this study

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))

Interventions

OTHER

Hybrid Endurance Strength Training

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.

OTHER

Usual Care

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.

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Anwar Suhaimi · Universiti Malaya Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2027-10-31
Completion
2027-12-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07130045 on ClinicalTrials.gov