Is the cardiac model of rehabilitation is more effective than standard care in reducing cerebrovascular risk factors post-transient ischaemic attack?

ISRCTN	ISRCTN88609279
DOI	https://doi.org/10.1186/ISRCTN88609279
Secondary identifying numbers	RHM MED0832; PRF/08/04

Submission date: 08/07/2009
Registration date: 11/09/2009
Last edited: 01/08/2013

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

Mr Hayden Kirk
Scientific

Rehabilitation Research, MP 886
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Email	hjsk1k06@soton.ac.uk

Study information

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
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	Ex4TIA Study
Study objectives	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(s)	Southampton and South West Hampshire Research Ethics Committee (B) approved on the 16th April 2009 (ref: 09/H0501/46)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	20/07/2009
Completion date	20/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	80
Key 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
Key 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
Date of first enrolment	20/07/2009
Date of final enrolment	20/10/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Rehabilitation Research, MP 886

Southampton
SO16 6YD
United Kingdom

Sponsor information

Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre

Research & Development
Duthie Building, MP 138
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England
United Kingdom

Phone	+44 (0)2380 795078
Email	Kelly.Waller@suht.swest.nhs.uk
Website	http://www.suht.nhs.uk/home.aspx
"ROR"	https://ror.org/0485axj58

Funders

Funder type

Research organisation

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

No information available

Private Physiotherapy Education Foundation (UK)

No information available

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?
Results article	results (patients' experiences)	01/09/2013		Yes	No