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:

* 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)
B: Inclusion Criteria:

* lacunar stroke verified by clinical examination and CT- or MRI-scans
* able to speak and read Danish

Exclusion Criteria:

* previous large artery stroke,
* symptoms or co-morbidities in the musculoskeletal system, which hinder bicycling,
* dyspnoea caused by heart or pulmonary disease,
* aphasia or dementia which hinder completion of the Talk Test.

Amendment 1 (version 4.0, June 2016) has been modified to allow an extended inclusion period from 0-21 days (previously 0-7 days).

Also, to allow inclusion of patients with recurrent lacunar stroke, with clinical symptoms and a corresponding ischemic lesion on MRI.

Amendment 2 (version 5.0, June 2017) has allowed inclusion from two other stroke units in the Capital Region of Copenhagen due to low recruitment rate. The article describes protocol version 5.0 from June 6th. 2017
C: Inclusion Criteria:

* ≥ 20years of age;
* diagnosis of stroke (\>6months);
* sedentary or insufficiently active;
* have a writing medical permission to participate in the training program.

Exclusion Criteria:

* cognitive impairment (Mini-Mental Status Examination score: illiterate 13 points; elementary and middle school 18 points; and high-school 26 points; or inability to respond to verbal command);
* inability to walk independently for at least 10 minutes, with or without walking devices;
* pain or other disorders precluding their participation.
D: Inclusion Criteria:

* Have been admitted to a hospital unit for stroke rehabilitation
* Within 10 weeks post-stroke
* 19 years or older
* Are experiencing difficulty walking

Exclusion Criteria:

* Requires greater than one person assist for transfer or ambulation
* Have uncontrolled medical condition or another serious medication condition in addition to stroke
* Unable to understand or follow directions

Answer: A