Angina Pectoris, Coronary Disease
Conditions
Keywords
Refractory angina, Cardiac rehabilitation, Symptomology, Physical ability, Exercise, Psychology, Quality of life, Risk factors
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCardiac rehabilitation
Phase III cardiac rehabilitation programme
Sponsors
British Heart Foundation
Royal Brompton & Harefield NHS Foundation Trust
National Heart and Lung Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health anxiety | Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) | Health anxiety questionnaire (HAQ) |
| Generalised anxiety and depression | Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) | Hospital Anxiety and Depression scale (HADS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anthropomometry | Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) | 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 |
| Fasting lipids | Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) | total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. Measured in biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques. |
| Social support | Baseline | Measured using the ENRICHED social support instrument (ESSI) |
| Angina related health beliefs | Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) | Measured using the York angina beliefs scale. |
| Physical activity and exercise capacity | Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) | Progressive shuttle walk test |
| Angina frequency and severity | Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) | Subjects completed a daily symptom monitoring diary |
| Systolic and diastolic blood pressure | Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) | Measured after 10 minutes sitting, using automated machine (eg. Omron machine) |
| Plasma glucose | Base, post intervention/monitoring, 8 weeks post intervention/monitoring | Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques. |
| Urea & electrolytes | Base, post intervention/monitoring, 8 weeks post intervention/monitoring | Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques |
| Liver function tests | Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring | Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques. |
| Thyroid function tests | Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring | Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques. |
| Hb | Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring | Measured in the haematology departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques. |
| HbA1C (if diabetic) | Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring | Measured in the haematology department of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques |
| Quality of life | Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) | SF-36 quality of life scale |
| Heart rate | Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) | Heart rate measured using automated machine (eg. Omron blood pressure machine) or manually at the radial pulse |
Countries
United Kingdom
Outcome results
None listed