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:

* 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.
B: Inclusion Criteria:

* Patients over 60 years of age
* Patients who have had a first stroke, transient or permanent, ischaemic or haemorrhagic, justifying hospitalisation
* Patients with high blood pressure already treated or discovered at the time of the stroke and justifying the start of a treatment
* Patients who have had a stroke with sequelae allowing immediate return home or justifying a stay of less than one month in rehabilitation
* Patient having a member of his social circle who has agreed to provide follow-up for two years in association with the assigned nursing personnel in case of randomisation into the "optimised follow-up" group.

Exclusion criteria

* Patients less than 60 years of age
* Patients with a history of stroke
* Patients who do not have high blood pressure discovered by a treatment prior to the stroke or by abnormal blood pressure figures during hospitalisation
* Patients who have had a stroke causing serious sequelae, justifying an extended stay in a rehabilitation department
* Patient who has no one in his social circle capable of working with the assigned nursing personnel, or patient living in an institution
C: 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)
D: Inclusion Criteria:

* Primary caregiver (unpaid family member or significant other) of a stroke survivor
* No more than 8 weeks after survivor discharged home
* Plans to be providing care for 1 year or longer
* Access to a telephone
* Willingness to participate in 9 calls from a nurse and 5 data collection interviews at designated study time points

Exclusion Criteria:

* Caregiver or survivor age \< 21 years
* Caregiver denies that survivor has had a stroke
* Caregiver does not consider him or herself a caregiver, stating that the survivor is not impaired or is the same as before the stroke
* Caregiver has low task difficulty (OCBS task difficulty score \< 16)
* Caregiver communication difficulties (e.g., hearing loss)
* Caregiver not fluent in the English language
* Caregiver 6-item MMSE score less than 4
* Survivor residing in a nursing home or long-term care facility
* Survivor or caregiver has a terminal illness (e.g., cancer, end of life condition with decreased life expectancy, renal failure requiring dialysis)
* Survivor or caregiver history of hospitalization for alcohol or drug abuse
* Survivor or caregiver history of severe mental illness (e.g., Alzheimer's, dementia, suicidal tendencies, severe untreated depression or manic depressive disorder, schizophrenia)
* Survivor or caregiver pregnancy
* Survivor or caregiver is a prisoner or on house arrest

Answer: C