Cardiovascular rehabilitation adapted to transient ischaemic attack and stroke
| ISRCTN | ISRCTN90272638 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90272638 |
| Secondary identifying numbers | HSR/2007/6 |
- 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
Scientific
School of Physiotherapy and Performance Science
Health Sciences Building
University College Dublin
Belfield
Dublin
4
Ireland
Study information
| Study design | A single blinded randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/10/2007 |
| Completion date | 31/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
4
Ireland
Sponsor information
Health Research Board (HRB) (Ireland)
Government
Government
73 Lower Baggot Street
Dublin
2
Ireland
| Website | http://www.hrb.ie |
|---|---|
"ROR" |
https://ror.org/003hb2249 |
Funders
Funder type
Government
Health Research Board (HRB) (Ireland) (ref: HSR/2007/6)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- HRB
- Location
- Ireland
University College Dublin (Ireland) (ref: Seed Fund SF109)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- UCD
- Location
- Ireland
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | pilot study | 01/02/2008 | Yes | No | |
| Results article | results | 01/09/2011 | Yes | No |
