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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN88609279
Enrollment
80
Registered
2009-09-11
Start date
2009-07-20
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular disease - transient ischaemic attack/minor strokes Circulatory System Transient cerebral ischaemic attacks and related syndromes

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 Tru

Sponsors

Southampton University Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026