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| ID | Type | Description | Link |
|---|---|---|---|
| PG/06/087/21239 | Other Grant/Funding Number | British Heart Foundation |
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| Name | Class |
|---|---|
| British Heart Foundation | OTHER |
| Royal Brompton & Harefield NHS Foundation Trust | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac rehabilitation | Experimental | 8-week cardiac rehabilitation programme |
|
| Monitoring | No Intervention | Carry on life as normal |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac rehabilitation | Behavioral | Phase III cardiac rehabilitation programme |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Collins, MA, MD, FRCP | National Heart and Lung Institute, Imperial College London | Principal Investigator |
| Kim Fox, MD, FRCP | Royal Brompton & Harefield NHS Foundation Trust | Principal Investigator |
| Mahmud Barbir, FRCP | Royal Brompton & Harefield NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Heart and Lung Institute, Imperial College London | London | SW3 6LY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11846493 | Background | Mannheimer C, Camici P, Chester MR, Collins A, DeJongste M, Eliasson T, Follath F, Hellemans I, Herlitz J, Luscher T, Pasic M, Thelle D. The problem of chronic refractory angina; report from the ESC Joint Study Group on the Treatment of Refractory Angina. Eur Heart J. 2002 Mar;23(5):355-70. doi: 10.1053/euhj.2001.2706. No abstract available. | |
| 14729809 |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D003327 | Coronary Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000072038 | Cardiac Rehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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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 |
| DeJongste MJ, Tio RA, Foreman RD. Chronic therapeutically refractory angina pectoris. Heart. 2004 Feb;90(2):225-30. doi: 10.1136/hrt.2003.025031. No abstract available. |
| 15860376 | Background | Gowda RM, Khan IA, Punukollu G, Vasavada BC, Nair CK. Treatment of refractory angina pectoris. Int J Cardiol. 2005 May 11;101(1):1-7. doi: 10.1016/j.ijcard.2004.03.066. |
| 10863051 | Background | Chester M, Hammond C, Leach A. Long-term benefits of stellate ganglion block in severe chronic refractory angina. Pain. 2000 Jul;87(1):103-105. doi: 10.1016/S0304-3959(00)00270-0. |
| 14622623 | Background | Stewart S. Refractory to medical treatment but not to nursing care: can we do more for patients with chronic angina pectoris? Eur J Cardiovasc Nurs. 2003 Sep;2(3):169-70. doi: 10.1016/S1474-5151(03)00067-7. No abstract available. |
| 15862480 | Background | Moore RK, Groves D, Bateson S, Barlow P, Hammond C, Leach AA, Chester MR. Health related quality of life of patients with refractory angina before and one year after enrolment onto a refractory angina program. Eur J Pain. 2005 Jun;9(3):305-10. doi: 10.1016/j.ejpain.2004.07.013. |
| 11806801 | Background | Lear SA, Ignaszewski A. Cardiac rehabilitation: a comprehensive review. Curr Control Trials Cardiovasc Med. 2001;2(5):221-232. doi: 10.1186/cvm-2-5-221. |
| 12576907 | Background | Hevey D, Brown A, Cahill A, Newton H, Kierns M, Horgan JH. Four-week multidisciplinary cardiac rehabilitation produces similar improvements in exercise capacity and quality of life to a 10-week program. J Cardiopulm Rehabil. 2003 Jan-Feb;23(1):17-21. doi: 10.1097/00008483-200301000-00004. |
| 12062135 | Background | Grace SL, Abbey SE, Shnek ZM, Irvine J, Franche RL, Stewart DE. Cardiac rehabilitation I: review of psychosocial factors. Gen Hosp Psychiatry. 2002 May-Jun;24(3):121-6. doi: 10.1016/s0163-8343(02)00178-0. |
| 12062136 | Background | Grace SL, Abbey SE, Shnek ZM, Irvine J, Franche RL, Stewart DE. Cardiac rehabilitation II: referral and participation. Gen Hosp Psychiatry. 2002 May-Jun;24(3):127-34. doi: 10.1016/s0163-8343(02)00179-2. |
| 10204976 | Background | Johnston M, Foulkes J, Johnston DW, Pollard B, Gudmundsdottir H. Impact on patients and partners of inpatient and extended cardiac counseling and rehabilitation: a controlled trial. Psychosom Med. 1999 Mar-Apr;61(2):225-33. doi: 10.1097/00006842-199903000-00015. |
| 10894639 | Background | Yoshida T, Kohzuki M, Yoshida K, Hiwatari M, Kamimoto M, Yamamoto C, Meguro S, Endo N, Kato A, Kanazawa M, Sato T. Physical and psychological improvements after phase II cardiac rehabilitation in patients with myocardial infarction. Nurs Health Sci. 1999 Sep;1(3):163-70. doi: 10.1046/j.1442-2018.1999.00021.x. |
| 11581152 | Background | Fletcher GF, Balady GJ, Amsterdam EA, Chaitman B, Eckel R, Fleg J, Froelicher VF, Leon AS, Pina IL, Rodney R, Simons-Morton DA, Williams MA, Bazzarre T. Exercise standards for testing and training: a statement for healthcare professionals from the American Heart Association. Circulation. 2001 Oct 2;104(14):1694-740. doi: 10.1161/hc3901.095960. No abstract available. |
| 15121495 | Background | Taylor RS, Brown A, Ebrahim S, Jolliffe J, Noorani H, Rees K, Skidmore B, Stone JA, Thompson DR, Oldridge N. Exercise-based rehabilitation for patients with coronary heart disease: systematic review and meta-analysis of randomized controlled trials. Am J Med. 2004 May 15;116(10):682-92. doi: 10.1016/j.amjmed.2004.01.009. |
| 15451147 | Background | Asbury EA, Creed F, Collins P. Distinct psychosocial differences between women with coronary heart disease and cardiac syndrome X. Eur Heart J. 2004 Oct;25(19):1695-701. doi: 10.1016/j.ehj.2004.07.035. |
| 22846707 | Result | Asbury EA, Webb CM, Probert H, Wright C, Barbir M, Fox K, Collins P. Cardiac rehabilitation to improve physical functioning in refractory angina: a pilot study. Cardiology. 2012;122(3):170-7. doi: 10.1159/000339224. Epub 2012 Jul 27. |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |