Condition category
Circulatory System
Date applied
30/07/2008
Date assigned
29/09/2008
Last edited
17/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Catherine Blake

ORCID ID

Contact details

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

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 measures

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

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

http://www.hrb.ie

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

academic

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes