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

NCT ID: NCT07243769

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2029-12-31

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Core Exercise group

tow sessions core exercise training per week

Group Type: EXPERIMENTAL

Core exercise training

Intervention Type: OTHER

Two core sessions per week, 1 hour per session. Pilates-based core endurance training progressing in difficulty with emphasis on breathing and posture; exercises performed in sitting, supine, prone, and quadruped positions.

Aerobic exercise group

two sessions aerobic training per week

Group Type: ACTIVE_COMPARATOR

conventional cardiac rehabilitation (aerobic training)

Intervention Type: OTHER

Two aerobic training sessions per week, 1 hour per session. Aerobic program targets 40-80% heart-rate reserve on a treadmill or cycle ergometer.

Combined exercise group

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

Group Type: ACTIVE_COMPARATOR

combined training

Intervention Type: OTHER

One core training session and one aerobic training session per week, 1hr per session. Core program (Pilates-based) progresses in difficulty with emphasis on breathing and posture; aerobic program targets 40-80% heart-rate reserve on a treadmill or cycle ergometer.

Interventions

Core exercise training

Two core sessions per week, 1 hour per session. Pilates-based core endurance training progressing in difficulty with emphasis on breathing and posture; exercises performed in sitting, supine, prone, and quadruped positions.

Intervention Type: OTHER

conventional cardiac rehabilitation (aerobic training)

Two aerobic training sessions per week, 1 hour per session. Aerobic program targets 40-80% heart-rate reserve on a treadmill or cycle ergometer.

Intervention Type: OTHER

combined training

One core training session and one aerobic training session per week, 1hr per session. Core program (Pilates-based) progresses in difficulty with emphasis on breathing and posture; aerobic program targets 40-80% heart-rate reserve on a treadmill or cycle ergometer.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hung-Jui Chuang, Dr.

Role: CONTACT

hjchuang@ntuh.gov.tw

+886972653162

Facility Contacts

Hung-Jui Chunag, Dr.

Role: primary

hjchuang@ntuh.gov.tw

+886972653162

Other Identifiers

202507175RINC

Identifier Type: -

Identifier Source: org_study_id