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ISRCTN
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ISRCTN90272638
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ClinicalTrials.gov identifier
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Public title
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Cardiovascular rehabilitation adapted to transient ischaemic attack and stroke
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Scientific title
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A randomised controlled trial to evaluate the benefit of a cardiac rehabilitation programme for improving fitness and reducing cardiovascular risk factors in the non-acute ischaemic stroke and transient ischaemic attack populations
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Acronym
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CRAFTS
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Serial number at source
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HSR/2007/6
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Study hypothesis
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A comprehensive cardiac rehabilitation programme involving aerobic exercise training, brief life-style intervention counselling and two didactic classes in risk reduction effects a greater change in cardiac risk score (as calculated from blood pressure, lipid profile, age, sex and diabetic status) and healthy lifestyle participation (exercise, diet and smoking cessation) than education classes alone.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Ethics approval received from the University of Dublin Human Research Ethics Sub-committee (ref: HREC-19-06-Blake) on the 25th May 2006. This included approval for a qualitative strand currently completed.
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Study design
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A single blinded randomised controlled trial
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Countries of recruitment
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Ireland
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Disease/condition/study domain
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Stroke, transient ischaemic attack
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Participants - inclusion criteria
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1. Adults of either gender aged greater than 18 years of age who have sustained an ischaemic stroke (confirmed by computed tomography [CT] or magnetic resonance imaging [MRI]) or a transient ischaemic attack (TIA)
2. Cerebrovascular accident [CVA] greater than one year recruited through the community with medical consent
3. CVA less than 1 year with consent of their hospital consultant
4. TIA greater than 3 months with consent of their hospital consultant
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Participants - exclusion criteria
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1. Major medical conditions
2. Oxygen dependence
3. Unstable cardiac conditions including angina
4. Uncontrolled diabetes
5. Claudication
6. Acute febrile illness
7. Cognitive impairment
8. Pregnancy
9. Uncontrolled diabetes
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Anticipated start date
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01/10/2007
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Anticipated end date
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31/10/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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240
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Interventions
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Over 8 weeks:
Control subjects will attend two one-hour educational session addressing risk factor reduction and lifeskills.
Intervention subjects will attend the two educational classes listed above. In addition they will attend for 16 one-hour aerobic training sessions and will receive brief intervention counselling individually tailored to their lifestyle risk factors and readiness to change on the transtheoretical model.
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Primary outcome measure(s)
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1. Adherence to the European guidelines for cardiovascular disease prevention in a high risk group as evidenced by the % of smokers, fruit and vegetable intake and habitual exercise, i.e. % taking moderate to vigorous activity greater than three times a week extrapolated from the International Physical Activity Questionnaire
2. Cardiac Risk Score
Baseline measures of the primary and secondary outcomes will be taken on week 1. Reassessment will be conducted on week 10 and at a one year interval.
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Secondary outcome measure(s)
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1. Physical fitness: VO2 as calculated from a steady state sub-maximal cycle ergometry test
2. Health related quality of life as measured by the Stroke Specific Quality of Life Index, Hospital Anxiety and Depression Scale, Functional Health Status COOP/WONCA Scale
3. Economic evaluation derived from EuroQol-5D
Baseline measures of the primary and secondary outcomes will be taken on week 1. Reassessment will be conducted on week 10 and at a one year interval.
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Sources of funding
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1. Health Research Board (HRB) (Ireland) (ref: HSR/2007/6)
2. University College Dublin (Ireland) (ref: Seed Fund SF109)
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Trial website
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Publications
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1. 2008 pilot study in http://www.ncbi.nlm.nih.gov/pubmed/18212034
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20813545
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Contact name
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Dr
Catherine
Blake
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Address
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School of Physiotherapy and Performance Science
Health Sciences Building
University College Dublin
Belfield
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City/town
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Dublin
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Zip/Postcode
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4
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Country
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Ireland
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Sponsor
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Health Research Board (HRB) (Ireland)
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Address
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73 Lower Baggot Street
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City/town
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Dublin
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Zip/Postcode
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2
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Country
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Ireland
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Sponsor website:
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http://www.hrb.ie
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Date applied
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30/07/2008
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Last edited
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17/01/2012
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Date ISRCTN assigned
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29/09/2008
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