Cardiac rehabilitation adapted to transient ischaemic attack and stroke (CRAFTS): a randomised controlled trial

Olive Lennon, Catherine Blake, Olive Lennon, Catherine Blake

Abstract

Background: Coronary Heart Disease and Cerebrovascular Disease share many predisposing, modifiable risk factors (hypertension, abnormal blood lipids and lipoproteins, cigarette smoking, physical inactivity, obesity and diabetes mellitus). Lifestyle interventions and pharmacological therapy are recognised as the cornerstones of secondary prevention. Cochrane review has proven the benefits of programmes incorporating exercise and lifestyle counselling in the cardiac disease population. A Cochrane review highlighted as priority, the need to establish feasibility and efficacy of exercise based interventions for Cerebrovascular Disease.

Methods: A single blind randomised controlled trial is proposed to examine a primary care cardiac rehabilitation programme for adults post transient ischemic attack (TIA) and stroke in effecting a positive change in the primary outcome measures of cardiac risk scores derived from Blood Pressure, lipid profile, smoking and diabetic status and lifestyle factors of habitual smoking, exercise and healthy eating participation. Secondary outcomes of interest include health related quality of life as measured by the Hospital Anxiety and Depression Scale, the Stroke Specific Quality of Life scale and WONCA COOP Functional Health Status charts and cardiovascular fitness as measured by a sub-maximal fitness test.A total of 144 patients, over 18 years of age with confirmed diagnosis of ischaemic stroke or TIA, will be recruited from Dublin community stroke services and two tertiary T.I.A clinics. Exclusion criteria will include oxygen dependence, unstable cardiac conditions, uncontrolled diabetes, major medical conditions, claudication, febrile illness, pregnancy or cognitive impairment. Participants will be block-statified, randomly allocated to one of two groups using a pre-prepared computer generated randomisation schedule. Both groups will receive a two hour education class on risk reduction post stroke. The intervention group will receive a 10 week programme of supervised aerobic exercises (twice weekly) and individually tailored brief intervention lifestyle counselling. Both groups will be tested on week one and week ten of the programme. Follow-up at 1 year will assess longer term benefits. Analysis will test for significant changes in the key variables indicated.

Discussion: Application of the Cardiac Rehabilitation paradigm to patients with ischaemic stroke or TIA has not been explored despite the obvious overlap in aetiology. It is hoped the anticipated improvement in vascular risk factors and fitness resulting from such a programme will enhance health and social gain in this population.

Trial registration: Current Controlled Trials ISCTRN90272638.

References

    1. Irish Heart Foundation in association with the Department of Health and Children . Irish Heart Foundation. Clyde Road, Dublin 4, Ireland; 2008. National Audit of Stroke Care.
    1. Gordon NF, Gulanick M, Costa F, Fletcher G, Franklin BA, Roth EJ, Shephard T. Physical activity and exercise recommendations for stroke survivors: an American Heart Association scientific statement from the Council on Clinical Cardiology, Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention; the Council on Cardiovascular Disease. Circulation. 2004;109:2031. doi: 10.1161/01.CIR.0000126280.65777.A4.
    1. Adams RJ, Chimowitz MI, Alpert JS, Awad IA, Cerqueria MD, Fayad P, Taubert KA. Coronary risk evaluation in patients with transient ischemic attack and ischemic stroke: a scientific statement for healthcare professionals from the Stroke Council and the Council on Clinical Cardiology of the American Heart Association/American Stroke Association. Circulation. 2003;108:1278–90. doi: 10.1161/.
    1. Chalmers J, Chapman N. Challenges for the prevention of primary and secondary stroke: the importance of lowering blood pressure and total cardiovascular risk. Blood Press. 2001;10:344–51.
    1. Wolf PA, Clagett GP, Easton JD, Goldstein LB, Gorelick PB, Kelly-Hayes M, Sacco RL, Whisnant JP, et al. Preventing ischemic stroke in patients with prior stroke and transient ischemic attack: a statement for healthcare professionals from the Stroke Council of the American Heart Association. Stroke. 1999;30:1991–4.
    1. Bennett K, Kabir Z, Unal B, Shelley E, Critchley J, Perry I, Feely J, Capewell S. Explaining the recent decrease in coronary heart disease mortality rates in Ireland, 1985–2000. Journal of Epidemiology and Community Health. 2006;60:322–327. doi: 10.1136/jech.2005.038638.
    1. Clark TG, Murphy MF, Rothwell PM. Long term risks of stroke, myocardial infarction, and vascular death in"low risk"patients with a non-recent transient ischaemic attack. J Neurol Neurosurg Psychiatry. 2003;74:577–80. doi: 10.1136/jnnp.74.5.577.
    1. Hankey GJ, Jamrozik K, Broadhurst RJ, Forbes S, Burvill PW, Anderson CS, Stewart-Wynne EG. Long-term risk of first recurrent stroke in the Perth Community Stroke Study. Stroke. 1998;29:2491–500.
    1. Tilling K, Sterne JA, Rudd AG, Glass TA, Wityk RJ, Wolfe CD. A new method for predicting recovery after stroke. Stroke. 2001;32:2867–73. doi: 10.1161/hs1201.099413.
    1. Coull AJ, Lovett JK, Rothwell PM. Population based study of early risk of stroke after transient ischaemic attack or minor stroke: implications for public education and organisation of services. BMJ. 2004;328:326. doi: 10.1136/bmj.37991.635266.44.
    1. Leira EC, Chang KC, Davis PH, Clarke WR, Woolson RF, Hansen MD, Adams HP., Jr Can we predict early recurrence in acute stroke? Cerebrovasc Dis. 2004;18:139–44. doi: 10.1159/000079267.
    1. Ebrahim S. Systematic review of cost-effectiveness research of stroke evaluation and treatment. Stroke. 1999;30:2759–2760.
    1. Pearson TA, Blair SN, Daniels SR, Eckel RH, Fair JM, Fortmann SP, Franklin BA, Goldstein LB, Greenland P, Grundy SM, Hong Y, Miller NH, Lauer RM, Ockene IS, Sacco RL, Sallis JF, Jr, Smith SC, Jr, Stone NJ, Taubert KA. AHA Guidelines for Primary Prevention of Cardiovascular Disease and Stroke: 2002 Update: Consensus Panel Guide to Comprehensive Risk Reduction for Adult Patients Without Coronary or Other Atherosclerotic Vascular Diseases. American Heart Association Scientific Statement. Circulation. 2002;106:388–91. doi: 10.1161/01.CIR.0000020190.45892.75.
    1. Thompson PD, Buchner D, Piña IL, Balady GD, Williams MA, Marcus BH, Berra K, Blair SN, Costa F, Franklin B, Fletcher GF, Gordon NF, Pate RR, Rodriguez BL, Yancey AK, Wenger NK, et al. AHA Scientific Statement. Exercise and Physical Activity in the Prevention and Treatment of Atherosclerotic Cardiovascular Disease. A Statement From the Council on Clinical Cardiology (Subcommittee on Exercise, Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity) Circulation. 2003;107:3109. doi: 10.1161/01.CIR.0000075572.40158.77.
    1. Jolliffe JA, Rees K, Taylor RS, Thompson D, Oldridge N, Ebrahim S. Exercise-based rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2000:CD001800.
    1. 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;116:682–92. doi: 10.1016/j.amjmed.2004.01.009.
    1. Saunders DH, Greig CA, Young A, Mead GE. Physical fitness training for stroke patients. Cochrane Database Syst Rev. 2004:CD003316.
    1. Roth EJ, Lovell L, Harvey RL, Heinemann AW, Semik P, Diaz S. Incidence of and risk factors for medical complications during stroke rehabilitation. Stroke. 2001;32:523–9.
    1. Potempa K, Lopez M, Braun LT, Szidon JP, Fogg L, Tincknell T. Physiological outcomes of aerobic exercise training in hemiparetic stroke patients. Stroke. 1995;26:101–5.
    1. da Cunha IT, Jr, Lim PA, Qureshy H, Henson H, Monga T, Protas EJ. Gait outcomes after acute stroke rehabilitation with supported treadmill ambulation training: a randomized controlled pilot study. Arch Phys Med Rehabil. 2002;83:1258–65. doi: 10.1053/apmr.2002.34267.
    1. Teixeira-Salmela LF, Nadeau S, Mcbride I, Olney SJ. Effects of muscle strengthening and physical conditioning training on temporal, kinematic and kinetic variables during gait in chronic stroke survivors. J Rehabil Med. 2001;33:53–60. doi: 10.1080/165019701750098867.
    1. American College of Sports Medicine's . Lippincott Williams and Wilkins, Philadelphia USA. 6. 2000. Guidelines for Exercise Testing and Prescription; pp. 165–193.
    1. Fletcher BJ, Dunbar SB, Felner JM, Jensen BE, Almon L, Cotsonis G, Fletcher GF. Exercise testing and training in physically disabled men with clinical evidence of coronary artery disease. Am J Cardiol. 1994;73:170–4. doi: 10.1016/0002-9149(94)90209-7.
    1. Chu KS, Eng JJ, Dawson AS, Harris JE, Ozkaplan A, Gylfadottir S. Water-based exercise for cardiovascular fitness in people with chronic stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2004;85:870–4. doi: 10.1016/j.apmr.2003.11.001.
    1. Macko RF, Ivey FM, Forrester LW, Hanley D, Sorkin JD, Katzel LI, Silver KH, Goldberg AP. Treadmill exercise rehabilitation improves ambulatory function and cardiovascular fitness in patients with chronic stroke: a randomized, controlled trial. Stroke. 2005;36:2206–11. doi: 10.1161/01.STR.0000181076.91805.89.
    1. Pang MY, Eng JJ, Dawson AS, McKay HA, Harris JE. A community-based fitness and mobility exercise program for older adults with chronic stroke: a randomized, controlled trial. J Am Geriatr Soc. 2005;53:1667–74.
    1. Lennon O, Carey C, Gaffney N, Stephenson J, Blake C. A pilot randomized controlled trial to evaluate the benefit of the cardiac rehabilitation paradigm for the non-acute ischaemic stroke population. Clinical Rehabilitation. 2008;22:125–133. doi: 10.1177/0269215507081580.
    1. Miles MB, Huberman AM. Thousand Oaks Sage. 2. 1994. Qualitative Data Analysis: an expanded sourcebook; pp. 50–88.
    1. Brunner E, Thorogood M, Rees K, Hewitt G. Dietary advice for reducing cardiovascular risk. Cochrane Database Syst Rev. 2005;4:CD002128.
    1. Lancaster T, Stead LF. Individual behavioural counselling for smoking cessation. Cochrane Database Syst Rev. 2005:CD001292.
    1. Critchley J, Capewell S. Smoking cessation for the secondary prevention of coronary heart disease. Cochrane Database Syst Rev. 2004:CD003041.
    1. Rees K, Bennett P, West R, Davey SG, Ebrahim S. Psychological interventions for coronary heart disease. Cochrane Database Syst Rev. 2004:CD002902.
    1. Calfas KJ, Sallis JF, Nichols JF. Project GRAD:two-year outcomes of a randomised controlled physical activity intervention among young adults. Graduate Ready for Activity Daily. Am J Prev Med. 2000;18:28–37. doi: 10.1016/S0749-3797(99)00117-8.
    1. Ockene IS, Herbert JR, Ockene JK. Effect of training and a structured office practice on physician-delivered nutrition counselling: the Worcester-Area Trial for Counselling in Hyperlipidaemia (WATCH) Am J Prev Med. 1996;12:252–258.
    1. Calfas KJ, Sallis JF, Zabinski MF. Preliminary evaluation of a multi-component programme for nutrition and physical activity change in primary care: PACE+for adults. Am J Prev Med. 2002;34:153–1610. doi: 10.1006/pmed.2001.0964.
    1. Havas S, Anliker J, Greenberg D. Final results of the Maryland food for life program. Prev Med. 2003;37:406–416. doi: 10.1016/S0091-7435(03)00160-9.
    1. Havas S, Anliker J, Damron D, Langenbeg GP, Ballesteros M, Feldman F. Final results from the Maryland WIC 5-a-day promotion program. Am J Public Health. 1998;88:1161–1176. doi: 10.2105/AJPH.88.8.1161.
    1. Wilson PW, D'Agostino RB, Levy D, Belanger AM, Silbershatz H, Kannel WB. Prediction of coronary heart disease using risk factor categories. Circulation. 1998;97:1837–47.
    1. European Society of Cardiology Guidelines on the fourth Joint European Societies' Task Force on cardiovascular disease prevention in clinical practice. European Journal of Cardiovascular Prevention and Rehabilitation. 2007;4
    1. Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35:1381–95. doi: 10.1249/01.MSS.0000078924.61453.FB.
    1. Zigmond AS, Smith RP. The hospital anxiety and depression scale. Acta Psychiatry Scand. 1983;67:361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Williams LS, Weinberger M, Harris LE, Clark DO, Biller J. Development of a stroke-specific quality of life scale. Stroke. 1999;30:1362–9.
    1. Van Weel C. Functional status in primary care: COOP/WONCA charts. Disabil Rehabil. 1993;15:96–101.
    1. World Health Organisation . Prevention of recurrent heart attacks and strokes in low and middle income populations. Evidence-based recommendations for policy makers and health professionals. World Health Organisation, Geneva, Switzerland; 2003.
    1. Gibbons RJ, Balady GJ, Beasley JW, Bricker JT, Duvernoy WF, Froelicher VF, Mark DB, Marwick TH, McCallister BD, Thompson PD, Jr, Winters WL, Yanowitz FG, Ritchie JL, Gibbons RJ, Cheitlin MD, Eagle KA, Gardner TJ, Garson A, Jr, Lewis RP, O'Rourke RA, Ryan TJ. ACC/AHA Guidelines for Exercise Testing. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Exercise Testing) J Am Coll Cardiol. 1997;30:260–311. doi: 10.1016/S0735-1097(97)00150-2.
    1. Twisk J, De Vente W. Attrition in longitudinal studies. How to deal with missing data. J Clin Epidemiol. 2002;55:329–337. doi: 10.1016/S0895-4356(01)00476-0.

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