The Impact of Cardiac Rehabilitation Participation on Cardiac Syndrome X - Full Text View

Purpose

The study is designed to test the hypothesis that participation in a standard phase III group based cardiac rehabilitation programme will improve psychological morbidity, quality of life and cardiovascular risk factors, along with chest pain severity and frequency in women with cardiac syndrome X.

Condition	Intervention	Phase
Microvascular Angina	Procedure: Phase III group based cardiac rehabilitation	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Impact of Cardiac Rehabilitation on Angina Frequency, Psychological Morbidity and Quality of Life in Women With Syndrome X

Resource links provided by NLM:

MedlinePlus related topics: Angina Anxiety Chest Pain Rehabilitation

U.S. FDA Resources

Further study details as provided by National Heart and Lung Institute:

Primary Outcome Measures:

Anxiety
Depression
Health anxiety
Cardiac anxiety
Quality of life
Symptom severity
Symptom frequency

Secondary Outcome Measures:

Cardiovascular risk factors
Physical ability
Time to pain

Estimated Enrollment:	64
Study Start Date:	January 2003
Estimated Study Completion Date:	March 2004

Show Detailed Description

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women
Aged 30 to 80 years
Postmenopausal > 1 year since last menstrual period
Angiographically normal coronary arteries
Positive treadmill exercise test for myocardial ischemia
Reported angina pectoris > 2 episodes per week
Diagnosis > 6 months
Willing to give written informed consent

Exclusion Criteria:

History of psychiatric illness
History of any other chronic illness
Participation in another research study within the previous 60 days
Suffer any physical condition for which exercise is a contra-indication.
Unwilling to give written informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123617

Locations

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

Sponsors and Collaborators

National Heart and Lung Institute

Investigators

Principal Investigator:

Peter Collins, MD FRCP

National Heart and Lung Institute, Imperial College London

More Information

Publications:

Kemp HG Jr, Vokonas PS, Cohn PF, Gorlin R. The anginal syndrome associated with normal coronary arteriograms. Report of a six year experience. Am J Med. 1973 Jun;54(6):735-42. No abstract available.

Cannon RO 3rd, Epstein SE. "Microvascular angina" as a cause of chest pain with angiographically normal coronary arteries. Am J Cardiol. 1988 Jun 1;61(15):1338-43. Review. No abstract available.

Raymond C. Chest pain not always what it seems; panic disorder may be cause in some. JAMA. 1989 Feb 24;261(8):1101-2. No abstract available.

Sax FL, Cannon RO 3rd, Hanson C, Epstein SE. Impaired forearm vasodilator reserve in patients with microvascular angina. Evidence of a generalized disorder of vascular function? N Engl J Med. 1987 Nov 26;317(22):1366-70. Erratum in: N Engl J Med 1987 Dec 24;317(26):1674.

Cannon RO 3rd, Bonow RO, Bacharach SL, Green MV, Rosing DR, Leon MB, Watson RM, Epstein SE. Left ventricular dysfunction in patients with angina pectoris, normal epicardial coronary arteries, and abnormal vasodilator reserve. Circulation. 1985 Feb;71(2):218-26.

Opherk D, Schuler G, Wetterauer K, Manthey J, Schwarz F, Kubler W. Four-year follow-up study in patients with angina pectoris and normal coronary arteriograms ("syndrome X") Circulation. 1989 Dec;80(6):1610-6.

Shapiro LM, Crake T, Poole-Wilson PA. Is altered cardiac sensation responsible for chest pain in patients with normal coronary arteries? Clinical observation during cardiac catheterisation. Br Med J (Clin Res Ed). 1988 Jan 16;296(6616):170-1. No abstract available.

Dean JD, Jones CJ, Hutchison SJ, Peters JR, Henderson AH. Hyperinsulinaemia and microvascular angina ("syndrome X") Lancet. 1991 Feb 23;337(8739):456-7.

Potts SG, Bass CM. Psychological morbidity in patients with chest pain and normal or near-normal coronary arteries: a long-term follow-up study. Psychol Med. 1995 Mar;25(2):339-47.

Ruggeri A, Taruschio G, Loricchio ML, Samory G, Borghi A, Bugiardini R. [The correlation between the clinical characteristics and psychological status in syndrome X patients] Cardiologia. 1996 Jun;41(6):551-7. Italian.

Mayou R. Chest pain, palpitations and panic. J Psychosom Res. 1998 Jan;44(1):53-70. Review.

Cunningham C, Brown S, Kaski JC. Effects of transcendental meditation on symptoms and electrocardiographic changes in patients with cardiac syndrome X. Am J Cardiol. 2000 Mar 1;85(5):653-5, A10.

Ornish D, Scherwitz LW, Doody RS, Kesten D, McLanahan SM, Brown SE, DePuey E, Sonnemaker R, Haynes C, Lester J, McAllister GK, Hall RJ, Burdine JA, Gotto AM Jr. Effects of stress management training and dietary changes in treating ischemic heart disease. JAMA. 1983 Jan 7;249(1):54-9.

Luebbert K, Dahme B, Hasenbring M. The effectiveness of relaxation training in reducing treatment-related symptoms and improving emotional adjustment in acute non-surgical cancer treatment: a meta-analytical review. Psychooncology. 2001 Nov-Dec;10(6):490-502.

Atienza F, Velasco JA, Brown S, Ridocci F, Kaski JC. Assessment of quality of life in patients with chest pain and normal coronary arteriogram (syndrome X) using a specific questionnaire. Clin Cardiol. 1999 Apr;22(4):283-90.

Sand NP, Juelsgaard P. [Syndrome X. Somatic and social prognosis of patients with angina pectoris and normal coronary arteriography] Ugeskr Laeger. 1994 Feb 21;156(8):1131-2, 1135-6. Danish.

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.

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.

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.

O'Callaghan WG, Teo KK, O'Riordan J, Webb H, Dolphin T, Horgan JH. Comparative response of male and female patients with coronary artery disease to exercise rehabilitation. Eur Heart J. 1984 Aug;5(8):649-51.

Woloshin S, Schwartz LM, Tosteson AN, Chang CH, Wright B, Plohman J, Fisher ES. Perceived adequacy of tangible social support and health outcomes in patients with coronary artery disease. J Gen Intern Med. 1997 Oct;12(10):613-8.

Horsten M, Mittleman MA, Wamala SP, Schenck-Gustafsson K, Orth-Gomer K. Depressive symptoms and lack of social integration in relation to prognosis of CHD in middle-aged women. The Stockholm Female Coronary Risk Study. Eur Heart J. 2000 Jul;21(13):1072-80.

Wenger NK. Social support and coronary heart disease in women: the challenge to learn more. Eur Heart J. 1998 Nov;19(11):1603-5. No abstract available.

Lindsay GM, Smith LN, Hanlon P, Wheatley DJ. The influence of general health status and social support on symptomatic outcome following coronary artery bypass grafting. Heart. 2001 Jan;85(1):80-6.

Anderson D, Posner N. Relationship between psychosocial factors and health behaviours for women experiencing menopause. Int J Nurs Pract. 2002 Oct;8(5):265-73.

Eriksson BE, Tyni-Lenne R, Svedenhag J, Hallin R, Jensen-Urstad K, Jensen-Urstad M, Bergman K, Selven C. Physical training in Syndrome X: physical training counteracts deconditioning and pain in Syndrome X. J Am Coll Cardiol. 2000 Nov 1;36(5):1619-25.

Tyni-Lenne R, Stryjan S, Eriksson B, Berglund M, Sylven C. Beneficial therapeutic effects of physical training and relaxation therapy in women with coronary syndrome X. Physiother Res Int. 2002;7(1):35-43.

Salmon P. Effects of physical exercise on anxiety, depression, and sensitivity to stress: a unifying theory. Clin Psychol Rev. 2001 Feb;21(1):33-61. Review.

Ransford HE, Palisi BJ. Aerobic exercise, subjective health and psychological well-being within age and gender subgroups. Soc Sci Med. 1996 Jun;42(11):1555-9.

Perrig-Chiello P, Perrig WJ, Ehrsam R, Staehelin HB, Krings F. The effects of resistance training on well-being and memory in elderly volunteers. Age Ageing. 1998 Jul;27(4):469-75.

ClinicalTrials.gov Identifier:	NCT00123617 History of Changes
Other Study ID Numbers:	02-239
Study First Received:	July 21, 2005
Last Updated:	July 29, 2005
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by National Heart and Lung Institute:

Chest pain
Women
Syndrome X

Cardiac rehabilitation
Psychological morbidity
Cardiovascular risk factors

Additional relevant MeSH terms:

Angina Pectoris
Microvascular Angina
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases

Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013