Please select the eligibility criteria that correspond to the clinical trial below.
Title: Stroke Prevention Rehabilitation Intervention Trial of Exercise - SPRITE - A Feasibility and Pilot Study
Brief Summary: BACKGROUND - Approximately 1,700 transient ischaemic attacks (TIAs) occur annually in NI with TIA survivors often being left with considerable functional impairment. TIA and strokes share common risk factors with cardiovascular disease. Cardiac rehabilitation post-myocardial infarction has shown significant reductions in morbidity and mortality, with home-based programmes producing better adherence and similar outcomes to hospital-and community-based programmes. However, the value of rehabilitation programmes for stroke prevention following a TIA or minor stroke is unclear.

AIMS - to determine if a novel rehabilitation programme, 'The Healthy Brain Rehabilitation Manual', for TIA/minor stroke patients can be developed, using MRC guidelines for developing complex health service interventions, from an approved home-based cardiac rehabilitation programme (the 'Heart Manual') and to undertake feasibility and pilot studies of the novel programme.

METHODS-All patients attending a TIA clinic in Belfast within 4 weeks of their first TIA/mild stroke will be invited to participate. The novel home-based programme manual will be developed following systematic reviews of the literature and qualitative exploration with the target population, using focus groups. A feasibility study will initially be undertaken lasting 6 weeks and then developed into a pilot trial of 12 weeks duration. The feasibility will recruit to 3 different treatments: (1) standard care; (2) standard care plus the manual; (3) standard care, manual plus a pedometer. Whilst for the pilot study there will also be 3 arms but this will include: 1) control group; 2) manual and pedometer supported by telephone follow-up with a GP; 3) manual and pedometer supported by telephone follow-up with a stroke nurse. Interviews and focus groups will be employed to assess the interventions' acceptability. The intervention, 'The Healthy Brain Rehabilitation Manual' will be refined and modified at all stages of the research.

CONCLUSIONS - The findings will inform the development of a novel secondary prevention programme, 'The Healthy Brain Rehabilitation Manual', for TIA/minor stroke patients and of a trial to test its effectiveness and longer-term potential to improve outcomes for TIA/stroke patients.


Options:
A: Inclusion Criteria:

* ischemic or hemorrhagic stroke
* within 1 month of discharge from hospital
* able to stand up from a chair with or without gait aid and walk at least 5 metres
* able to understand 2-step commands

Exclusion Criteria:

* Have other neurological problems besides stroke or medically unstable.
B: Inclusion Criteria:

* 18 years of age or older
* male or female
* attendee at a participating TIA clinic within 4 weeks of a first suspected TIA
* diagnosed with a TIA or 'minor' stroke, due to atherosclerosis or small vessel occlusion (diagnosis based on the TOAST classification system (69)(70), following neurological examination and neuroimaging (32)).

Exclusion Criteria:

* patients who have experienced more than one TIA and/or stroke
* inability to give informed consent
* presenting after 4 weeks of their first suspected TIA and/or 'minor' stroke
* contra-indication for exercise training, based on guidelines of the American College of Sports Medicine(72)
C: Inclusion Criteria:

* Subjects aged 40 years or older.
* Patients with a clinical diagnosis of stroke; symptoms lasting 24 hours or more.
* Computed tomography (CT)-scan of the brain must either show a new infarct or be normal. Patients only with infarcts without clinical symptoms cannot be included.
* Inclusion shall take place before day 90 after stroke onset.
* Informed consent after verbal and written information.
* The patient must be able to walk either unaided or with a cane or a walker.

Exclusion Criteria:

* Patients who are unable to understand the information, or who cannot cooperate, are excluded.
* Patients confined to a wheelchair or bed.
* CT-scanning showing intracranial haemorrhage or focal pathology other than infarction, cerebral atrophy, or leucoaraiosis.
* Modified Rankin score of 4 or 5 before the actual stroke.
* Serious medical disease such as AIDS, metastatic cancer, or abnormalities that the investigator feels may compromise the patient's successful participation in the trial.
* Earlier randomisation in this trial.
D: Inclusion Criteria:

* Males and females
* Over 17 years of age.
* Diagnosis of first probable or definite TIA or non-disabling stroke (National Institutes of Health Stroke Scale \< 6)
* Post-event interval of \<90 days.
* Residence within 75 km of intervention site.
* Orientation to time, place and person and ability to follow simple 3-step commands.
* Ability and willingness to provide informed consent.

Exclusion Criteria:

* Evidence of intracranial hemorrhage on MRI or CT scan.
* Presence of contraindications to exercise testing and training, in accordance with American College of Sports Medicine Guidelines.
* Participation in another study that could potentially confound the outcomes of this trial.

Answer: B