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

Recruitment status:
Not recruiting
Primary Sponsor:
Southampton University Hospitals NHS Trust (UK)
Recruitment countries:
United Kingdom
Health condition studied:
Cerebrovascular disease - transient ischaemic attack/minor strokes
URL:
Link to the clinical trial website

About the trial

Interventions:
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.
Key inclusion and exclusion criteria:
  • 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
  • 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
  • Age minimum: 
  • Age maximum: 
  • Gender: 
Primary outcomes:
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 outcomes:
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
Target sample size:
80
Study type:
Interventional
Study design:
Single centre exploratory single-blind two group randomised controlled phase II feasibility study
Contacts:
  • Name: Hayden Kirk
  • Address:  Rehabilitation Research, MP 886 Southampton General Hospital Tremona Road
  • Phone: 
  • Email:  hjsk1k06@soton.ac.uk
  • Affiliation: 

Technical details

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
Sources of monetary support:
1. Physiotherapy Research Foundation (UK) (ref: PRF/08/04) 2. Private Physiotherapy Education Foundation (UK)
Secondary sponsors:
N/A
Main ID:
ISRCTN88609279
Secondary ID:
RHM MED0832; PRF/08/04
Register:
ISRCTN
Date of registration:
11/09/2009
Date of first enrollment:
Jul 20 2009
Last refreshed:
8 December 2014

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