A Pilot Randomized Controlled Trial Comparing Core Exercise, Aerobic Exercise, and Combined Exercise in Patients Undergoing Phase II Cardiac Rehabilitation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Peak oxygen uptake
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Core Exercise group
tow sessions core exercise training per week
干预措施: Core exercise training (Other)
Aerobic exercise group
two sessions aerobic training per week
干预措施: conventional cardiac rehabilitation (aerobic training) (Other)
Combined exercise group
one session core exercise training and one session aerobic training per week
干预措施: combined training (Other)
结局指标
主要结局
Peak oxygen uptake
时间窗: Week 0 and after 8-week training program
The peak oxygen uptake (VO₂peak) is measured using a cardiopulmonary exercise testing (CPET).
次要结局
- 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)
- Lumbo-pelvic control test(At Week 0 and after 8-week training program)
- 30 seconds sit to stand test(From enrollment to the end of treatment at 8 weeks)
- Hand grip strength(From enrollment to the end of treatment at 8 weeks)
- Time to exhaustion at 80% of VO₂peak(At Week 0 and after 8-week training program)
- Body composition(At Week 0 and after 8-week training program)