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

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.