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

NCT07243769 | Recruiting

• 1 other identifier: 202507175RINC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Peak oxygen uptake

  The peak oxygen uptake (VO₂peak) is measured using a cardiopulmonary exercise testing (CPET).

  Week 0 and after 8-week training program

Secondary Outcomes (10)

• Six-minute walk distance

  Week 0 and after 8-week training program

• One-leg stand test

  At Week 0 and after 8-week training program

• Plank endurance

  At Week 0 and after 8-week training program

• Side plank endurance

  At Week 0 and after 8-week training program

• Trunk flexor endurance test

  At Week 0 and after 8-week training program

Study Arms (3)

Core Exercise group

EXPERIMENTAL

tow sessions core exercise training per week

Other: Core exercise training

Aerobic exercise group

ACTIVE COMPARATOR

two sessions aerobic training per week

Other: conventional cardiac rehabilitation (aerobic training)

Combined exercise group

ACTIVE COMPARATOR

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

Other: combined training

Interventions

Core exercise training 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.

Core Exercise group

conventional cardiac rehabilitation (aerobic training) 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.

Aerobic exercise group

combined training 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.

Combined exercise group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Heart Failure; Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Hung-Jui Chuang, Dr.

CONTACT

+886972653162; hjchuang@ntuh.gov.tw

Study Design

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

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: November 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)