Cardiac Rehabilitation for the Treatment of Refractory Angina

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.

Study Overview

• Status: Completed
• Conditions: Coronary Disease; Angina Pectoris
• Intervention / Treatment: Behavioral: Cardiac rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6LY
    • National Heart and Lung Institute, Imperial College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Heart and Lung Institute
• Collaborators: Royal Brompton & Harefield NHS Foundation Trust; British Heart Foundation
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: December 12, 2006
• First Submitted That Met QC Criteria: December 12, 2006
• First Posted (Estimate): December 14, 2006

Study Record Updates

• Last Update Posted (Estimate): April 22, 2015
• Last Update Submitted That Met QC Criteria: April 21, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Exercise; Quality of life; Cardiac rehabilitation; Risk factors; Psychology; Refractory angina; Symptomology; Physical ability
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Coronary Disease; Angina Pectoris
• Other Study ID Numbers: 06/Q0404/77; PG/06/087/21239 (Other Grant/Funding Number: British Heart Foundation)