Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HSR/2007/6
Study information
Scientific title
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
Acronym
CRAFTS
Study hypothesis
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.
Ethics approval
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.
Study design
A single blinded randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Stroke, transient ischaemic attack
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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.
Secondary outcome measures
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.
Overall trial start date
01/10/2007
Overall trial end date
31/10/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
240
Participant exclusion criteria
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
Recruitment start date
01/10/2007
Recruitment end date
31/10/2010
Locations
Countries of recruitment
Ireland
Trial participating centre
School of Physiotherapy and Performance Science
Dublin
4
Ireland
Sponsor information
Organisation
Health Research Board (HRB) (Ireland)
Sponsor details
73 Lower Baggot Street
Dublin
2
Ireland
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Health Research Board (HRB) (Ireland) (ref: HSR/2007/6)
Alternative name(s)
HRB
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Ireland
Funder name
University College Dublin (Ireland) (ref: Seed Fund SF109)
Alternative name(s)
UCD
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
Ireland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
Publication citations
-
Pilot study
Lennon O, Carey A, 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., Clin Rehabil, 2008, 22, 2, 125-133, doi: 10.1177/0269215507081580.
-
Results
Lennon OC, Carey A, Creed A, Durcan S, Blake C, Reliability and validity of COOP/WONCA functional health status charts for stroke patients in primary care., J Stroke Cerebrovasc Dis, 20, 5, 465-473, doi: 10.1016/j.jstrokecerebrovasdis.2010.02.020.