Stroke Prevention Rehabilitation Intervention Trial of Exercise (SPRITE) - A Randomised Feasibility Study
Cardiac rehabilitation post-myocardial infarction is beneficial but its value after a transient ischaemic attack (TIA) or minor stroke is untested despite these conditions sharing similar pathology. We aimed to design a novel home-based rehabilitation programme for patients following a TIA/minor stroke. This study’s primary objective was to test the feasibility of conducting a randomized controlled trial (RCT) to evaluate the programme, by assessing rates of recruitment, retention and completion of outcome measures and exploring participants’ views.
Patients attending hospital clinics within 4 weeks of a first TIA or minor stroke of atherosclerotic origin, were invited to allow contact from the researcher. Those who consented undertook assessments of their physical and mental health, before random allocation to: Group (1) standard/usual care; (2) rehabilitation manual or (3) manual plus pedometer. Participants received telephone support at 1 and 4 weeks, and were re-assessed at 6 weeks. Their views regarding the manual and study were explored in a focus group.
From 107 clinic attendees, 28 (15 men; 13 women) were invited to participate; the eligibility of 79 was not confirmed. We achieved our target sample: 15 (10 men, 5 women; mean age 69 years) consented and all completed the study. Mean time to enrolment was 20.5 days. Group 3 increased pedometer step-counts (mean steps/day 8,356 to 9,763). In Groups 2 and 3 sedentary time (IPAQ score) fell (mean -1.6 hrs, SD -1.52; -1.2 hrs, SD -1.1) and anxiety, depression and diet improved (Hospital Anxiety and Depression Scale; Mediterranean Diet Score). Participants completed all assessments except maximal VO2 testing. The manual was welcomed, particularly regarding its information about stroke. Pedometers were valued, particularly for goal-setting. Participants drew support from others’ experiences.
Our findings indicate that a RCT of a novel home-based rehabilitation programme, ‘The Healthy Brain Rehabilitation Manual’, within 4 weeks of a first TIA/minor stroke is feasible. However, refinement of design is needed, in recording patient eligibility and invitation; the manual content will be re-ordered and a patient’s story included; an alternative test to VO2 max is required and 12-week follow-up will be tested, in a pilot trial prior to definitive RCT of the programme’s effectiveness in early stroke prevention. Trial registration - ClinicalTrials.gov Identifier: NCT02712385.