Cardiac Rehabilitation for the Treatment of Refractory Angina

• Health anxiety [ Time Frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) ] [ Designated as safety issue: No ]
  Health anxiety questionnaire (HAQ)
  
  
• Generalised anxiety and depression [ Time Frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) ] [ Designated as safety issue: No ]
  Hospital Anxiety and Depression scale (HADS)
  
  

• Systolic and diastolic blood pressure [ Time Frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) ] [ Designated as safety issue: No ]
  Measured after 10 minutes sitting, using automated machine (eg. Omron machine)
  
  
• Heart rate [ Time Frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) ] [ Designated as safety issue: No ]
  Heart rate measured using automated machine (eg. Omron blood pressure machine) or manually at the radial pulse
  
  
• Anthropomometry [ Time Frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) ] [ Designated as safety issue: No ]
  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 [ Time Frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) ] [ Designated as safety issue: No ]
  total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. Measured in biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.
  
  
• Social support [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  Measured using the ENRICHED social support instrument (ESSI)
  
  
• Angina related health beliefs [ Time Frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) ] [ Designated as safety issue: No ]
  Measured using the York angina beliefs scale.
  
  
• Physical activity and exercise capacity [ Time Frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) ] [ Designated as safety issue: No ]
  Progressive shuttle walk test
  
  
• Angina frequency and severity [ Time Frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) ] [ Designated as safety issue: No ]
  Subjects completed a daily symptom monitoring diary
  
  
• Quality of life [ Time Frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) ] [ Designated as safety issue: No ]
  SF-36 quality of life scale
  
  
• Plasma glucose [ Time Frame: Base, post intervention/monitoring, 8 weeks post intervention/monitoring ] [ Designated as safety issue: No ]
  Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.
  
  
• Urea & electrolytes [ Time Frame: Base, post intervention/monitoring, 8 weeks post intervention/monitoring ] [ Designated as safety issue: No ]
  Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques
  
  
• Liver function tests [ Time Frame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring ] [ Designated as safety issue: No ]
  Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.
  
  
• Thyroid function tests [ Time Frame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring ] [ Designated as safety issue: No ]
  Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.
  
  
• Hb [ Time Frame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring ] [ Designated as safety issue: No ]
  Measured in the haematology departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.
  
  
• HbA1C (if diabetic) [ Time Frame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring ] [ Designated as safety issue: No ]
  Measured in the haematology department of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques
  
  

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.