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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Phase III cardiac rehabilitation programme
National Heart and Lung Institute, Imperial College London
London, United Kingdom
Health anxiety
Health anxiety questionnaire (HAQ)
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Generalised anxiety and depression
Hospital Anxiety and Depression scale (HADS)
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Systolic and diastolic blood pressure
Measured after 10 minutes sitting, using automated machine (eg. Omron machine)
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Heart rate
Heart rate measured using automated machine (eg. Omron blood pressure machine) or manually at the radial pulse
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Anthropomometry
Weight, height, waist circumference (tape measure), hip circumference (tape measure), body mass index calculated from height and weight using the following website: http://www.nhlbisupport.com/bmi/bmi-m.htm
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Fasting lipids
total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. Measured in biochemistry departments of the Royal Brompton \& Harefield NHS Foundation Trust using standard techniques.
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
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Social support
Measured using the ENRICHED social support instrument (ESSI)
Time frame: Baseline
Angina related health beliefs
Measured using the York angina beliefs scale.
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Physical activity and exercise capacity
Progressive shuttle walk test
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Angina frequency and severity
Subjects completed a daily symptom monitoring diary
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Quality of life
SF-36 quality of life scale
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Plasma glucose
Measured in the biochemistry departments of the Royal Brompton \& Harefield NHS Foundation Trust using standard techniques.
Time frame: Base, post intervention/monitoring, 8 weeks post intervention/monitoring
Urea & electrolytes
Measured in the biochemistry departments of the Royal Brompton \& Harefield NHS Foundation Trust using standard techniques
Time frame: Base, post intervention/monitoring, 8 weeks post intervention/monitoring
Liver function tests
Measured in the biochemistry departments of the Royal Brompton \& Harefield NHS Foundation Trust using standard techniques.
Time frame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
Thyroid function tests
Measured in the biochemistry departments of the Royal Brompton \& Harefield NHS Foundation Trust using standard techniques.
Time frame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
Hb
Measured in the haematology departments of the Royal Brompton \& Harefield NHS Foundation Trust using standard techniques.
Time frame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
HbA1C (if diabetic)
Measured in the haematology department of the Royal Brompton \& Harefield NHS Foundation Trust using standard techniques
Time frame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring