Stroke Prevention Rehabilitation Intervention Trial of Exercise (SPRITE)

: A Randomised Feasibility and Pilot Study

Student thesis: Doctoral ThesisDoctor of Philosophy

Abstract

Introduction:
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.

Aims:
To develop and test the feasibility of conducting a randomised controlled trial of a novel home-based rehabilitation programme, ‘The Healthy Brain Rehabilitation Manual’, with a pedometer, for patients with a first TIA or ‘minor’ stroke of atherosclerotic origin, utilising the core components of home-based CR. This thesis describes the systematic reviews of the literature, qualitative research and feasibility and pilot studies of the intervention, developed according to the Medical ResearchCouncil (MRC) guidelines for developing complex health service interventions.

Method:
Systematic literature reviews informed adaptation of a home-based CR manual. This was further refined through 3 focus groups (TIA/minor stroke patients and carers; clinical academics; and health professionals). Next, a 6 week feasibility study randomly allocated participants to 3 arms: (1) standard/usual care; (2) manual; (3) manual plus a pedometer. All groups received telephone follow-up at 1 and 4 weeks post-enrolment. Biophysical and questionnaire assessments at baseline and 6-weeks included VO2max testing. Two trained review authors independently assessed the manual to identify the Behaviour Change Techniques (BCTs) used.

For the 12 week pilot trial participants were randomly allocated to: (1) standard care (n=12); (2) manual plus pedometer with telephone follow-up by General Practitioner
(GP) (n=14); (3) manual plus pedometer with telephone follow-up by stroke nurse (n=14). The telephone follow-up was undertaken at 1, 4 and 9 weeks. Focus groups
were undertaken to explore participants’ views on the intervention. Eligibility criteria for both the feasibility and pilot studies included being within 4 weeks of a first TIA or
‘minor’ stroke.

Results
a) Systematic review 1:
Only 4 studies were identified which utilised lifestyle interventions within the first 90 days following a TIA and/or ‘minor’ stroke, highlighting the dearth of evidence of
non-pharmacological interventions in this area. The main behaviour change techniques (BCTs) used within the included studies were goal setting and instructions about how
to perform given behaviours.

b) Systematic review 2:
I reviewed the BCTs utilised in home-based CR and published between 2005-2015. Twenty different BCTs were used in the 11 included studies, with social support
(unspecified) used in all studies and goal setting (behaviour) in 10. Of the 11 studies, 10 reported effectiveness in reducing CVD risk factors.

c) Feasibility Study:
Twenty-eight patients were invited to participate, with 15 (10 men, 5 women; 9 TIA, 6 minor stroke; mean age 69 years) consenting. Participants completed all assessment
measures except VO2max testing, which all declined. The intervention was viewed positively and pedometers valued highly, particularly for goal-setting. Overall, 36
BCTs were used in the intervention, commonest centred around goal setting, planning and social support.

d) Pilot Study:
Of 125 eligible patients, 44(35.2%) consented to initial study contact, with 40(90.9%) participating and 39(97.5%) completing the study. From baseline to follow-up, there
was a general improvement in cardiovascular risk factors in the intervention arms. Qualitative work with participants and stroke nurses confirmed acceptability of the
research study and intervention with some amendments suggested.

Conclusions:
It is feasible to conduct a trial to evaluate the effectiveness of a novel home-based CR programme, ‘The Healthy Brain Rehabilitation Manual’, implemented within 4 weeks
of a first TIA/minor stroke. This intervention has been developed following the MRC guidelines, with clear patient and public involvement, and has demonstrated
improvements in cardiovascular risk factors. The commonest BCTs used within the manual revolve around goals, planning and social support. The findings from the
feasibility and pilot work will be used to further refine the next stage of the intervention’s development, a randomised controlled trial, powered to detect
reductions in systolic blood pressure.
Date of AwardJul 2018
Original languageEnglish
Awarding Institution
  • Queen's University Belfast
SupervisorMichael Donnelly (Supervisor), Frank Kee (Supervisor), Jonathan Mant (Supervisor) & Margaret Cupples (Supervisor)

Cite this

Stroke Prevention Rehabilitation Intervention Trial of Exercise (SPRITE): A Randomised Feasibility and Pilot Study
Heron, N. (Author). Jul 2018

Student thesis: Doctoral ThesisDoctor of Philosophy