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

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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.
• Другое 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.

Первичные конечные точки

• Peak oxygen uptake [Срок оценки: Week 0 and after 8-week training program]

Вторичные конечные точки (10)

• Six-minute walk distance [Срок оценки: Week 0 and after 8-week training program]
• One-leg stand test [Срок оценки: At Week 0 and after 8-week training program]
• Plank endurance [Срок оценки: At Week 0 and after 8-week training program]
• Side plank endurance [Срок оценки: At Week 0 and after 8-week training program]
• Trunk flexor endurance test [Срок оценки: At Week 0 and after 8-week training program]
• Lumbo-pelvic control test [Срок оценки: At Week 0 and after 8-week training program]
• 30 seconds sit to stand test [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Hand grip strength [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Time to exhaustion at 80% of VO₂peak [Срок оценки: At Week 0 and after 8-week training program]
• Body composition [Срок оценки: At Week 0 and after 8-week training program]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• National Taiwan University Hospital — Taipei

Идентификаторы

NCT: NCT07243769 · 202507175RINC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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