A Pilot Randomized Controlled Trial Comparing Core Exercise, Aerobic Exercise, and Combined Exercise in Patients Undergoing Phase II Cardiac Rehabilitation.

National Taiwan University

Status: Enrolling

Conditions: Clinically Stable Myocardial Infarction or Heart Failure Patients; Myocardial Infarction (MI); Heart Failure

Treatments: Other: combined training; Other: Core exercise training; Other: conventional cardiac rehabilitation (aerobic training)

Study type: Interventional

Funder types: Other

Identifiers

NCT07243769

202507175RINC

Details and patient eligibility

About

Cardiac rehabilitation (CR) is recommended after myocardial infarction (MI) or heart failure (HF), yet the added value of core muscle endurance training within CR remains uncertain. This randomized, three-arm trial will enroll 60 adults with stable MI or HF who are referred to Phase II CR. After consent and baseline testing, participants are allocated 1:1:1 to: (1) Pilates-based core endurance training, (2) standard aerobic CR (treadmill or cycle), or (3) combined aerobic plus core training. Supervised sessions occur twice weekly for eight weeks (~60 minutes/session) with continuous safety monitoring. The primary aim is to evaluate feasibility and safety of core training in this population. The study also compares effects of the three programs on cardiorespiratory fitness and function (e.g., peak oxygen uptake, six-minute walk distance), core endurance, balance, symptoms, and health-related quality of life. Findings will clarify whether adding core training improves outcomes and inform clinical exercise prescription in CR.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 18 years.
• Diagnosed with myocardial infarction or heart failure with stable condition, and referred for participation in Phase II cardiac rehabilitation.
• Able to regularly attend training sessions twice a week.

Exclusion criteria

• Underwent cardiac surgery within the past three months.
• Presence of a pacemaker, defibrillator, or left ventricular assist device.
• Cognitive impairment or dementia that prevents understanding or following training instructions.
• Inability to complete cardiopulmonary exercise testing.
• Pregnancy.
• Contraindications to cardiac rehabilitation based on the American College of Sports Medicine (ACSM) guidelines, such as unstable angina, uncontrolled severe hypertension (resting systolic BP >180 mmHg or diastolic BP >110 mmHg), orthostatic hypotension (drop in BP >20 mmHg upon position change), severe aortic stenosis, uncontrolled severe arrhythmia, decompensated heart failure, third-degree atrioventricular block, acute pericarditis or myocarditis, aortic dissection, acute pulmonary embolism, or other acute medical conditions such as infection or fever.
• Refusal to participate in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Core Exercise group

Experimental group

Description:

tow sessions core exercise training per week

Treatment:

Other: Core exercise training

Aerobic exercise group

Active Comparator group

Description:

two sessions aerobic training per week

Treatment:

Other: conventional cardiac rehabilitation (aerobic training)

Combined exercise group

Active Comparator group

Description:

one session core exercise training and one session aerobic training per week

Treatment:

Other: combined training