NCT02712385: SPRITE

Stroke Prevention Rehabilitation Intervention Trial of Exercise (SPRITE)

Completed NA Last updated 4 April 2023

What this trial tests

NA trial testing 'The Healthy Brain Rehabilitation Manual' in Cerebrovascular Disorders in 40 participants. Completed in 1 March 2018.

Timeline

1 March 2016

Primary endpoint
31 December 2017

1 March 2018

Quick facts

Lead sponsor	Queen's University, Belfast
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	40
Start date	1 March 2016
Primary completion	31 December 2017
Estimated completion	1 March 2018
Sites	4 locations across United Kingdom

Drugs / interventions tested

• 'The Healthy Brain Rehabilitation Manual'
• Pedometer
• Usual care
• Telephone follow-up

Conditions studied

• Cerebrovascular Disorders — all drugs for Cerebrovascular Disorders →

Sponsor

Queen's University, Belfast

Who can join

18 and older, any sex, with Cerebrovascular Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions for improving modifiable risk factor control in the secondary prevention of stroke.
   Bridgwood B, Lager KE, Mistri AK, Khunti K, et al · · 2018 · cited 66× · PMID 29734470 · DOI 10.1002/14651858.cd009103.pub3
2. Interventions for reducing sedentary behaviour in people with stroke.
   Saunders DH, Mead GE, Fitzsimons C, Kelly P, et al · · 2021 · cited 34× · PMID 34184251 · DOI 10.1002/14651858.cd012996.pub2
3. Stroke Prevention Rehabilitation Intervention Trial of Exercise (SPRITE) - a randomised feasibility study.
   Heron N, Kee F, Mant J, Reilly PM, et al · · 2017 · cited 21× · PMID 29233087 · DOI 10.1186/s12872-017-0717-9
4. Rehabilitation of patients after transient ischaemic attack or minor stroke: pilot feasibility randomised trial of a home-based prevention programme.
   Heron N, Kee F, Mant J, Cupples ME, et al · · 2019 · cited 14× · PMID 31501165 · DOI 10.3399/bjgp19x705509
5. Optimising secondary prevention in the acute period following a TIA of ischaemic origin.
   Heron N. · · 2016 · cited 4× · PMID 29616144 · DOI 10.1136/bmjsem-2016-000161
6. Cardiac rehabilitation for the transient ischaemic attack (TIA) and stroke population? Using the Medical Research Council (MRC) guidelines for developing complex health service interventions to develop home-based cardiac rehabilitation for TIA and 'minor' stroke patients.
   Heron N. · · 2019 · cited 3× · PMID 30181325 · DOI 10.1136/bjsports-2018-099593