Cardiac Rehabilitation for the Treatment of Refractory Angina
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Health anxiety
研究概览
简要总结
The purpose of this study is to determine whether cardiac rehabilitation is a successful treatment for refractory angina, in relation to improvements in cardiovascular risk factors, physical ability, symptomology, quality of life and psychological morbidity.
详细描述
The majority of patients presenting with angina pectoris resulting from coronary artery disease (CHD) are successfully treated with interventions including coronary artery bypass grafting (CABG) and percutaneous transluminal coronary angioplasty (PTCA) and medical management. However, a growing number of patients experience persistent angina in spite of intervention and optimal medical treatment. Such patients are referred to as suffering from 'refractory angina'.
Currently, cardiac rehabilitation centres are reluctant to accept patients with ongoing angina or complicated cardiovascular history, in spite of the duration or stability of the symptoms. Indeed, angina and heart failure are often used to exclude patients from cardiac rehabilitation. However, in the recent updated American Heart Association (AHA) recommendations for exercise and training, cardiac rehabilitation and supervised exercise training is recommended for patients with ongoing angina, previous history of CABG, MI, PTCA and patients with existing cardiomyopathy in order to promote a reduction in myocardial ischaemia at rest and during sub-maximal exercise, while reducing the risk for the progression of CHD. Nevertheless, studies exploring the physiological and psychological impact of routinely available CR as a stand-alone intervention among refractory angina patients have not previously been undertaken. Until such studies are performed, CR practitioners will continue to refuse to accept refractory angina patients for participation in CR.
Research questions:
- Is an eight-week cardiac rehabilitation exercise programme an appropriate treatment option for patients with refractory angina?
- Does an eight-week cardiac rehabilitation exercise programme improve the physical functioning and cardiovascular health of patients with refractory angina?
- Is symptom severity and frequency reduced following an eight-week cardiac rehabilitation exercise programme in patients with refractory angina?
- Does an eight-week cardiac rehabilitation exercise programme have any impact on anxiety, depression, cardiac anxiety and quality of life in patients with refractory angina?
- Are any physiological or psychological effects acquired by patients with refractory angina participating in a cardiac rehabilitation exercise programme maintained at an eight-week follow-up?
The study is conceived as a randomised intervention-control study of a standard, routinely available Phase III hospital-based CR program among patients with refractory angina. Patients will be randomly assigned to an eight-week CR programme based at Harefield Hospital or symptom diary monitoring control group.
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
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed with refractory angina > 6 months
- •Two or more episodes of angina per week
- •Males and females aged 30 - 80
- •Previous history of single or multiple myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or any combination of the above
- •Prescribed optimal medical therapy
- •AHA exercise and training guidelines classification B and C
- •Willing to give written informed consent
排除标准
- •History of any other chronic illness
- •AHA exercise and training guidelines classification class D
- •Suffer any physical condition for which exercise is a contra-indication
- •Participation in two or more periods of planned moderate intensity exercise per week during the past 6 months
- •Participation in another research study within the previous 60 days
- •History of psychiatric illness
- •Unwilling to give written informed consent
结局指标
主要结局
Health anxiety
时间窗: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Health anxiety questionnaire (HAQ)
Generalised anxiety and depression
时间窗: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Hospital Anxiety and Depression scale (HADS)
次要结局
- Systolic and diastolic blood pressure(Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring))
- Heart rate(Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring))
- Anthropomometry(Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring))
- Fasting lipids(Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring))
- Social support(Baseline)
- Angina related health beliefs(Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring))
- Physical activity and exercise capacity(Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring))
- Angina frequency and severity(Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring))
- Quality of life(Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring))
- Plasma glucose(Base, post intervention/monitoring, 8 weeks post intervention/monitoring)
- Urea & electrolytes(Base, post intervention/monitoring, 8 weeks post intervention/monitoring)
- Liver function tests(Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring)
- Thyroid function tests(Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring)
- Hb(Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring)
- HbA1C (if diabetic)(Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring)
研究者
Prof. Peter Collins
Professor of Clinical Cardiology
National Heart and Lung Institute