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Stroke Prevention Rehabilitation Intervention Trial of Exercise (SPRITE) - a randomised feasibility study
Authors:Neil Heron  Jonathan Mant  Philip M Reilly  Margaret Cupples  Mark Tully  Michael Donnelly
Institution:1.Department of General Practice and Primary Care,Queen’s University,Belfast,UK;2.Centre for Public Health Research,Queen’s University,Belfast,UK;3.UKCRC Centre of Excellence for Public Health Research (NI),Belfast,Northern Ireland;4.Primary Care Unit, Department of Public Health and Primary Care,University of Cambridge, Strangeways Research Laboratory,Cambridge,UK;5.Patient and Public Involvement (PPI) Representative for SPRITE Studies,Belfast,Northern Ireland;6.Department of General Practice,Queen’s University, Dunluce Health Centre,Belfast,UK
Abstract:

Background

The value of cardiac rehabilitation (CR) after a transient ischaemic attack (TIA) or minor stroke is untested despite these conditions sharing similar pathology and risk factors to coronary heart disease. We aimed to evaluate the feasibility of conducting a trial of an adapted home-based CR programme, ‘The Healthy Brain Rehabilitation Manual’, for patients following a TIA/minor stroke, participants’ views on the intervention and, to identify the behaviour change techniques (BCTs) used.

Methods

Clinicians were asked to identify patients attending the Ulster Hospital, Belfast within 4 weeks of a first TIA or minor stroke. Those who agreed to participate underwent assessments of physical fitness, cardiovascular risk, quality of life and mental health, before random allocation to: Group (1) standard/usual care; (2) rehabilitation manual or (3) manual plus pedometer. All participants received telephone support at 1 and 4 weeks, reassessment at 6 weeks and an invitation to a focus group exploring views regarding the study. Two trained review authors independently assessed the manual to identify the BCTs used.

Results

Twenty-eight patients were invited to participate, with 15 (10 men, 5 women; 9 TIA, 6 minor stroke; mean age 69 years) consenting and completing the study. Mean time to enrolment from the TIA/stroke was 20.5 days. Participants completed all assessment measures except VO2max testing, which all declined. The manual and telephone contact were viewed positively, as credible sources of advice. Pedometers were valued highly, particularly for goal-setting. Overall, 36 individual BCTs were used, the commonest being centred around setting goals and planning as well as social support.

Conclusion

Recruitment and retention rates suggest that a trial to evaluate the effectiveness of a novel home-based CR programme, implemented within 4 weeks of a first TIA/minor stroke is feasible. The commonest BCTs used within the manual revolve around goals, planning and social support, in keeping with UK national guidelines. The findings from this feasibility work have been used to further refine the next stage of the intervention’s development, a pilot study.

Trial registration

ClinicalTrials.gov Identifier: NCT02712385. This study was registered prospectively on 18/03/2016.
Keywords:
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