ISRCTN88609279 - Is the cardiac model of rehabilitation is more effective than standard care in reducing cerebrovascular risk factors post-transient ischaemic attack?

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23 May 2012

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Is the cardiac model of rehabilitation is more effective than standard care in reducing cerebrovascular risk factors post-transient ischaemic attack?

ISRCTN	ISRCTN88609279
ClinicalTrials.gov identifier
Public title	Is the cardiac model of rehabilitation is more effective than standard care in reducing cerebrovascular risk factors post-transient ischaemic attack?
Scientific title	A single centre phase II feasibility study evaluating if the cardiac model of rehabilitation is more effective than standard care in reducing cerebrovascular risk factors post-transient ischaemic attack
Acronym	Ex4TIA Study
Serial number at source	RHM MED0832; PRF/08/04
Study hypothesis	Providing a cardiac model of rehabilitation (exercise and lifestyle strategies) for people within one month of a transient ischaemic attack (TIA)/minor stroke will improve their physiological status and reduce their vascular risk as defined by the cardiovascular and cerebrovascular score. We will ask the following questions: 1. Does the intervention produce significant physiological changes associated with atherosclerotic disease? 2. Does the intervention enhance lifestyle changes more effectively than standard care? 3. Do the patients perceive any benefit from the intervention in relation to standard care?
Lay summary
Ethics approval	Southampton and South West Hampshire Research Ethics Committee (B) approved on the 16th April 2009 (ref: 09/H0501/46)
Study design	Single centre exploratory single-blind two group randomised controlled phase II feasibility study
Countries of recruitment	United Kingdom
Disease/condition/study domain	Cerebrovascular disease - transient ischaemic attack/minor strokes
Participants - inclusion criteria	1. Diagnosis (within 1 month of incident) of: 1.1. TIA - resolution of symptoms less than 24 hours of onset (not suspected patent foramen ovale [PFO]), or 1.2. Minor stroke - National Institutes of Health Stroke Scale (NIHSS) score less than 3 2. Lives within geographic locality (GP postcodes) 3. Independently mobile (can use stick but no falls within 2 months) 4. No significant visual/speech impairment 5. Cognitive capacity to undertake group exercises (no apparent dementia) 6. Able to give verbal and written consent 7. Aged greater than 18 years, either sex 8. Considered medically fit for exercise (Canadian Angina score and SIGN 2002 guidance) 9. No previous experience of cardiac rehabilitation 10. No current or recent participation in research
Participants - exclusion criteria	1. TIA of suspected patent foramen ovale (hole in heart) origin with no other significant vascular risk factors 2. Live outside of the area covered by Southampton Cardiac Rehabilitation Team 3. Aphasia or other communication problems affecting ability to consent or to understand information given 4. Apparent dementia or significant cognitive impairment (mini-mental test [MMT] score less than 7) 5. Previously undertaken cardiac rehabilitation 6. Involved in current research or have recently been involved in any research
Anticipated start date	20/07/2009
Anticipated end date	20/10/2010
Status of trial	Completed
Patient information material	Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants	80
Interventions	Although a single centre study, this trial is registered for ethical purposes as a two site study as recruitment occurs in a different site (Acute Hospital Trust) to the intervention (Primary Care Trust). Intervention group: Cardiac Rehabilitation Programme (Exercise and Lifestyle Education). Participants will have baseline data collected within 1 month of their cerebrovascular event following which they will then be randomised to standard care or standard care and cardiac rehabilitation with endpoint data collection 5 months subsequently. The intervention is an existing standard NHS cardiac rehabilitation programme consisting of Phases 2 - 4: Phase 2 = risk stratification, education, family involvement and support Phase 3 = structured exercise & education sessions Phase 4 = patient directed continuation of the exercise component and the long term maintenance of individual goals Control group: Standard care. All participants primary and secondary outcomes (with the exception of the qualitative interviews) will be recorded at the same time. Participants will have initial baseline measures recorded within one month of their cerebrovascular event (TIA/minor stroke). All participants will then continue for a five month period with standard care (routine TIA investigations and pharmaceutical treatments along with a short piece of lifestyle advice) or standard care and the intervention. All participants will return for endpoint data collection in the fifth month after initial baseline data collection. A number of patients will then be randomly selected (estimation 20) to be interviewed in order to gain a subjective analysis of their views regarding standard care and the cardiac model of rehabilitation.
Primary outcome measure(s)	Cardiac Risk Score: an algorithmic score that assesses the future risk of cardiac events based on age, sex, smoking status, resting blood pressure, diabetic status, total cholesterol and high-density/low-density lipoprotein cholesterol. Measured at baseline and 5 months.
Secondary outcome measure(s)	Measured at baseline and 5 months: 1. Biomarkers (C-reactive protein, fibrinogen) 2. Cardiovascular Disease Score: similar to the Cardiac Risk Score but allows for the identification of cerebrovascular risk 3. Exercise frequency: self-reported 4. Exercise capacity: maximal oxygen uptake (VO2) estimation derived from the Astrand-Rhyming cycle ergometer test (for participants not taking Beta Blockers) 5. Obesity: body mass index (BMI) and Waist-to-Hip ratio 6. Diet: quantity of fruit and vegetables consumed daily 7. Mood: Hospital Anxiety and Depression (HAD) score 8. Quality of Life: 36-item short form health survey (SF-36) 9. Qualitative analyses - purposive sampling of up to 10 participants from each arm with thematic analyses of semi-structured interviews
Sources of funding	1. Physiotherapy Research Foundation (UK) (ref: PRF/08/04) 2. Private Physiotherapy Education Foundation (UK)
Trial website
Publications
Contact name	Mr Hayden Kirk
Address	Rehabilitation Research, MP 886 Southampton General Hospital Tremona Road
City/town	Southampton
Zip/Postcode	SO16 6YD
Country	United Kingdom
Email	hjsk1k06@soton.ac.uk
Sponsor	Southampton University Hospitals NHS Trust (UK)
Address	Research & Development Duthie Building, MP 138 Southampton General Hospital Tremona Road
City/town	Southampton
Zip/Postcode	SO16 6YD
Country	United Kingdom
Tel	+44 (0)2380 795078
Email	Kelly.Waller@suht.swest.nhs.uk
Sponsor website:	http://www.suht.nhs.uk/home.aspx
Date applied	08/07/2009
Last edited	11/09/2009
Date ISRCTN assigned	11/09/2009


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