Cardiac Rehabilitation for the Treatment of Refractory Angina

Coronary Disease Clinical Trial

Official title:

Cardiac Rehabilitation for the Treatment of Refractory Angina

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00411359
• Other study ID #: 06/Q0404/77
• Secondary ID: PG/06/087/21239
• Status: Completed
• Phase: Phase 3
• First received: December 12, 2006
• Last updated: April 21, 2015
• Start date: December 2006
• Est. completion date: April 2010

Study information

• Verified date: April 2015
• Source: National Heart and Lung Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease

Intervention

Behavioral:
• Cardiac rehabilitation
Phase III cardiac rehabilitation programme

Locations

Country	Name	City	State
United Kingdom	National Heart and Lung Institute, Imperial College London	London

Sponsors (3)

Lead Sponsor	Collaborator
National Heart and Lung Institute	British Heart Foundation, Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (16)

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. — View Citation

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. — View Citation

Chester M, Hammond C, Leach A. Long-term benefits of stellate ganglion block in severe chronic refractory angina. Pain. 2000 Jul;87(1):103-5. — View Citation

DeJongste MJ, Tio RA, Foreman RD. Chronic therapeutically refractory angina pectoris. Heart. 2004 Feb;90(2):225-30. Review. — View Citation

Fletcher GF, Balady GJ, Amsterdam EA, Chaitman B, Eckel R, Fleg J, Froelicher VF, Leon AS, Piña 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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Lear SA, Ignaszewski A. Cardiac rehabilitation: a comprehensive review. Curr Control Trials Cardiovasc Med. 2001;2(5):221-232. — View Citation

Mannheimer C, Camici P, Chester MR, Collins A, DeJongste M, Eliasson T, Follath F, Hellemans I, Herlitz J, Lüscher 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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health anxiety	Health anxiety questionnaire (HAQ)	Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)	No
Primary	Generalised anxiety and depression	Hospital Anxiety and Depression scale (HADS)	Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Social support	Measured using the ENRICHED social support instrument (ESSI)	Baseline	No
Secondary	Angina related health beliefs	Measured using the York angina beliefs scale.	Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)	No
Secondary	Physical activity and exercise capacity	Progressive shuttle walk test	Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)	No
Secondary	Angina frequency and severity	Subjects completed a daily symptom monitoring diary	Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)	No
Secondary	Quality of life	SF-36 quality of life scale	Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No