Stroke Prevention Rehabilitation Intervention Trial of Exercise (SPRITE) - A Randomised Feasibility Study

Conference: 
SAPC ASM 2017 - Warwick
Talk Code: 
EP1A.09
Presenter: 
Neil Heron
Co-authors: 
Prof Frank Kee 1,2, 3 (MD), Prof Jonathan Mant4 (MD), Philip M Reilly5, Prof Michael Donnelly 1,2, 3 (PhD), Prof Margaret Cupples 1,2, 3 (MD).
Author institutions: 
1Dept of General Practice and Primary Care, Queen’s University, Belfast; 2 Centre for Public Health Research, Queen’s University, Belfast; 3 Centre of Excellence for Public Health Research (NI); 4Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Strangeways Research Laboratory, Cambridge, UK; 5Patient and Public Involvement (PPI) representative for SPRITE s

Problem

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.

Approach

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.

Findings

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.

Consequences

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.

Submitted by: 
Neil Heron
Funding acknowledgement: 
This research was funded by the National Institute of Health Research (NIHR) PhD Academic Clinical Fellowship and the British Association of Sport and Exercise Medicine (BASEM) Doctoral Fellowship awards for the lead author, Dr Neil Heron.