RecruitingNot ApplicableNCT07243769

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


Sponsor

National Taiwan University Hospital

Enrollment

60 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria7

  • 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.

Interventions

OTHERCore 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.

OTHERconventional 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.

OTHERcombined 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.


Locations(1)

National Taiwan University Hospital

Taipei, Taiwan

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NCT07243769


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