Please select the outcome measures 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: Rate of recruitment to the studies (12 weeks (pilot study))
B: Difference in the 'Graded Cycling Test with Talk Test' (at baseline, 3 (primary analysis), 6 and 12 months after baseline testing)
C: Change from baseline in Physical activity levels - multisensor monitor (At baseline, 12 weeks post-intervention, and at 4-week follow-up); Change from baseline in Physical activity levels - Human Activity Profile (At baseline, 12 weeks post-intervention, and at 4-week follow-up); Change from baseline in sedentary behavior - multisensor monitor (At baseline, 12 weeks post-intervention, and at 4-week follow-up)
D: Ambulatory function measured by the Six Minute Walk Test (Rehabilitation discharge (average 4-5 weeks post admission))

Answer: A