Cardiovascular rehabilitation adapted to transient ischaemic attack and stroke

ISRCTN	ISRCTN90272638
DOI	https://doi.org/10.1186/ISRCTN90272638
Protocol serial number	HSR/2007/6
Sponsor	Health Research Board (HRB) (Ireland)
Funders	Health Research Board (HRB) (Ireland) (ref: HSR/2007/6), University College Dublin (Ireland) (ref: Seed Fund SF109)

Submission date: 30/07/2008
Registration date: 29/09/2008
Last edited: 17/01/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Catherine Blake
Scientific

School of Physiotherapy and Performance Science
Health Sciences Building
University College Dublin
Belfield
Dublin
4
Ireland

Study information

Primary study design	Interventional
Study design	A single blinded randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	CRAFTS
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	240
Key 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
Key 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
Date of first enrolment	01/10/2007
Date of final enrolment	31/10/2010

Locations

Countries of recruitment

Ireland

Study participating centre

School of Physiotherapy and Performance Science

Dublin
4
Ireland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2011		Yes	No
Other publications	pilot study	01/02/2008		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes