Condition category
Circulatory System
Date applied
08/07/2009
Date assigned
11/09/2009
Last edited
01/08/2013
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

Mr Hayden Kirk

ORCID ID

Contact details

Rehabilitation Research
MP 886
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
hjsk1k06@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RHM MED0832; PRF/08/04

Study information

Scientific title

A single centre phase II feasibility study evaluating if the cardiac model of rehabilitation is more effective than standard care in reducing cerebrovascular risk factors post-transient ischaemic attack

Acronym

Ex4TIA Study

Study hypothesis

Providing a cardiac model of rehabilitation (exercise and lifestyle strategies) for people within one month of a transient ischaemic attack (TIA)/minor stroke will improve their physiological status and reduce their vascular risk as defined by the cardiovascular and cerebrovascular score. We will ask the following questions:
1. Does the intervention produce significant physiological changes associated with atherosclerotic disease?
2. Does the intervention enhance lifestyle changes more effectively than standard care?
3. Do the patients perceive any benefit from the intervention in relation to standard care?

Ethics approval

Southampton and South West Hampshire Research Ethics Committee (B) approved on the 16th April 2009 (ref: 09/H0501/46)

Study design

Single centre exploratory single-blind two group randomised controlled phase II feasibility study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cerebrovascular disease - transient ischaemic attack/minor strokes

Intervention

Although a single centre study, this trial is registered for ethical purposes as a two site study as recruitment occurs in a different site (Acute Hospital Trust) to the intervention (Primary Care Trust).

Intervention group:
Cardiac Rehabilitation Programme (Exercise and Lifestyle Education). Participants will have baseline data collected within 1 month of their cerebrovascular event following which they will then be randomised to standard care or standard care and cardiac rehabilitation with endpoint data collection 5 months subsequently. The intervention is an existing standard NHS cardiac rehabilitation programme consisting of Phases 2 - 4:
Phase 2 = risk stratification, education, family involvement and support
Phase 3 = structured exercise & education sessions
Phase 4 = patient directed continuation of the exercise component and the long term maintenance of individual goals

Control group:
Standard care.

All participants primary and secondary outcomes (with the exception of the qualitative interviews) will be recorded at the same time. Participants will have initial baseline measures recorded within one month of their cerebrovascular event (TIA/minor stroke). All participants will then continue for a five month period with standard care (routine TIA investigations and pharmaceutical treatments along with a short piece of lifestyle advice) or standard care and the intervention. All participants will return for endpoint data collection in the fifth month after initial baseline data collection. A number of patients will then be randomly selected (estimation 20) to be interviewed in order to gain a subjective analysis of their views regarding standard care and the cardiac model of rehabilitation.

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

Cardiac Risk Score: an algorithmic score that assesses the future risk of cardiac events based on age, sex, smoking status, resting blood pressure, diabetic status, total cholesterol and high-density/low-density lipoprotein cholesterol. Measured at baseline and 5 months.

Secondary outcome measures

Measured at baseline and 5 months:
1. Biomarkers (C-reactive protein, fibrinogen)
2. Cardiovascular Disease Score: similar to the Cardiac Risk Score but allows for the identification of cerebrovascular risk
3. Exercise frequency: self-reported
4. Exercise capacity: maximal oxygen uptake (VO2) estimation derived from the Astrand-Rhyming cycle ergometer test (for participants not taking Beta Blockers)
5. Obesity: body mass index (BMI) and Waist-to-Hip ratio
6. Diet: quantity of fruit and vegetables consumed daily
7. Mood: Hospital Anxiety and Depression (HAD) score
8. Quality of Life: 36-item short form health survey (SF-36)
9. Qualitative analyses - purposive sampling of up to 10 participants from each arm with thematic analyses of semi-structured interviews

Overall trial start date

20/07/2009

Overall trial end date

20/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis (within 1 month of incident) of:
1.1. TIA - resolution of symptoms less than 24 hours of onset (not suspected patent foramen ovale [PFO]), or
1.2. Minor stroke - National Institutes of Health Stroke Scale (NIHSS) score less than 3
2. Lives within geographic locality (GP postcodes)
3. Independently mobile (can use stick but no falls within 2 months)
4. No significant visual/speech impairment
5. Cognitive capacity to undertake group exercises (no apparent dementia)
6. Able to give verbal and written consent
7. Aged greater than 18 years, either sex
8. Considered medically fit for exercise (Canadian Angina score and SIGN 2002 guidance)
9. No previous experience of cardiac rehabilitation
10. No current or recent participation in research

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. TIA of suspected patent foramen ovale (hole in heart) origin with no other significant vascular risk factors
2. Live outside of the area covered by Southampton Cardiac Rehabilitation Team
3. Aphasia or other communication problems affecting ability to consent or to understand information given
4. Apparent dementia or significant cognitive impairment (mini-mental test [MMT] score less than 7)
5. Previously undertaken cardiac rehabilitation
6. Involved in current research or have recently been involved in any research

Recruitment start date

20/07/2009

Recruitment end date

20/10/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Rehabilitation Research, MP 886
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

Southampton University Hospitals NHS Trust (UK)

Sponsor details

Research & Development
Duthie Building
MP 138
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)2380 795078
Kelly.Waller@suht.swest.nhs.uk

Sponsor type

Government

Website

http://www.suht.nhs.uk/home.aspx

Funders

Funder type

Research organisation

Funder name

Physiotherapy Research Foundation (UK) (ref: PRF/08/04)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Private Physiotherapy Education Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2013 results (patients' experiences) in http://www.ncbi.nlm.nih.gov/pubmed/23543342

Publication citations

  1. Hillsdon KM, Kersten P, Kirk HJ, A qualitative study exploring patients' experiences of standard care or cardiac rehabilitation post minor stroke and transient ischaemic attack., Clin Rehabil, 2013, 27, 9, 845-853, doi: 10.1177/0269215513478956.

Additional files

Editorial Notes