A Pilot Randomized Controlled Trial Comparing Core Exercise, Aerobic Exercise, and Combined Exercise in Patients Undergoing Phase II Cardiac Rehabilitation.
Recruiting · NCT07243769 · Interventional (participants receive a specific treatment) · Lead sponsor: National Taiwan University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
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.
Where it is running
1 location listed.
- National Taiwan University Hospital - Taipei, Taiwan