Cardiac Rehabilitation for the Treatment of Refractory Angina

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cardiac Rehabilitation for the Treatment of Refractory Angina

Conditions
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Angina Pectoris, Coronary Disease

Intervention / Treatment
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* Behavioral: Cardiac rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac rehabilitation<br>8-week cardiac rehabilitation programme | Behavioral: Cardiac rehabilitation<br>* Phase III cardiac rehabilitation programme<br>|
| No Intervention: Monitoring<br>Carry on life as normal | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health anxiety | Health anxiety questionnaire (HAQ) | Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) | 
| Generalised anxiety and depression | Hospital Anxiety and Depression scale (HADS) | Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic and diastolic blood pressure | Measured after 10 minutes sitting, using automated machine (eg. Omron machine) | 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 | 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 | 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. | Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) | 
| Social support | Measured using the ENRICHED social support instrument (ESSI) | Baseline | 
| Angina related health beliefs | Measured using the York angina beliefs scale. | Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) | 
| Physical activity and exercise capacity | Progressive shuttle walk test | Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) | 
| Angina frequency and severity | Subjects completed a daily symptom monitoring diary | Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) | 
| Quality of life | SF-36 quality of life scale | 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. | 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 | 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. | 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. | 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. | 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 | Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractory angina, Cardiac rehabilitation, Symptomology, Physical ability, Exercise, Psychology, Quality of life, Risk factors