Please select the arm or intervention descriptions that belong 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: Arm Label: STUFFS; Type: EXPERIMENTAL; Interventions: Behavioral: Sedentary behaviour intervention | Intervention Type: BEHAVIORAL; Name: Sedentary behaviour intervention; Assigned to Arm(s): STUFFS
B: Arm Label: Control - usual care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Manual; Type: ACTIVE_COMPARATOR; Interventions: Other: 'The Healthy Brain Rehabilitation Manual', Procedure: Usual care | Arm Label: Manual + pedometer, 1; Type: ACTIVE_COMPARATOR; Interventions: Other: 'The Healthy Brain Rehabilitation Manual', Device: Pedometer, Procedure: Usual care, Behavioral: Telephone follow-up | Arm Label: Manual + pedometer, 2; Type: ACTIVE_COMPARATOR; Interventions: Other: 'The Healthy Brain Rehabilitation Manual', Device: Pedometer, Procedure: Usual care, Behavioral: Telephone follow-up | Intervention Type: OTHER; Name: 'The Healthy Brain Rehabilitation Manual'; Assigned to Arm(s): Manual, Manual + pedometer, 1, Manual + pedometer, 2 | Intervention Type: DEVICE; Name: Pedometer; Assigned to Arm(s): Manual + pedometer, 1, Manual + pedometer, 2 | Intervention Type: PROCEDURE; Name: Usual care; Assigned to Arm(s): Manual, Manual + pedometer, 1, Manual + pedometer, 2 | Intervention Type: BEHAVIORAL; Name: Telephone follow-up; Assigned to Arm(s): Manual + pedometer, 1, Manual + pedometer, 2
C: Arm Label: Intervention arm; Type: EXPERIMENTAL; Interventions: Behavioral: Instruction in physical training program | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Instruction in physical training program; Assigned to Arm(s): Intervention arm
D: Arm Label: PREVENT program; Type: EXPERIMENTAL; Interventions: Behavioral: PREVENT program | Arm Label: Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Usual Care | Intervention Type: BEHAVIORAL; Name: PREVENT program; Assigned to Arm(s): PREVENT program | Intervention Type: BEHAVIORAL; Name: Usual Care; Assigned to Arm(s): Usual Care

Answer: B