Stroke Prevention Rehabilitation Intervention Trial of Exercise (SPRITE)

NCT02712385 | Completed DMC

• 1 other identifier: CDV/5053/14
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Cerebrovascular Disorders

Outcome Measures

Primary Outcomes (1)

• Rate of recruitment to the studies

  Recruitment rate calculated as percentage of potentially eligible patients who agree to participate

  12 weeks (pilot study)

Secondary Outcomes (5)

• Change in Level of physical activity

  Baseline to 12 weeks

• Change in Body Mass Index (BMI)

  Baseline to 12 weeks

• Change in Quality of life

  Baseline to 12 weeks

• Change in Blood pressure

  Baseline and 12 weeks

• Change in Physical function

  Baseline and 12 weeks

Study Arms (4)

Control - usual care

NO INTERVENTION

Usual post-TIA/minor stroke care as per current healthcare system protocol will be given to patients in control group and details will be recorded.

Manual

ACTIVE COMPARATOR

Receiving usual post-TIA/minor stroke care plus 'The Healthy Brain Rehabilitation Manual'.

Other: 'The Healthy Brain Rehabilitation Manual'; Procedure: Usual care

Manual + pedometer, 1

ACTIVE COMPARATOR

Receiving usual post-TIA/minor stroke care plus 'The Healthy Brain Rehabilitation Manual' and a pedometer with telephone follow-up from a General Practitioner.

Other: 'The Healthy Brain Rehabilitation Manual'; Device: Pedometer; Procedure: Usual care; Behavioral: Telephone follow-up

Manual + pedometer, 2

ACTIVE COMPARATOR

Receiving usual post-TIA/minor stroke care plus 'The Healthy Brain Rehabilitation Manual' and a pedometer with telephone follow-up from a Stroke nurse.

Other: 'The Healthy Brain Rehabilitation Manual'; Device: Pedometer; Procedure: Usual care; Behavioral: Telephone follow-up

Interventions

'The Healthy Brain Rehabilitation Manual' OTHER

The Healthy Brain Rehabilitation Manual is a home-based rehabilitation manual developed for the post-TIA and minor stroke population caused by ischaemic events. The manual addresses all the secondary prevention factors required post-ischaemic TIA/minor stroke, e.g. smoking cessation, physical activity promotion.

Manual; Manual + pedometer, 1; Manual + pedometer, 2

Pedometer DEVICE

Pedometer used to measure step counts as an objective measurement of level of physical activity.

Manual + pedometer, 1; Manual + pedometer, 2

Usual care PROCEDURE

Usual care provided by healthcare system for patients who suffer a TIA or minor stroke will be recorded and form 'active comparator' control.

Manual; Manual + pedometer, 1; Manual + pedometer, 2

Telephone follow-up BEHAVIORAL

Telephone follow-up by either a General Practitioner (GP) or Stroke nurse.

Manual + pedometer, 1; Manual + pedometer, 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• male or female
• attendee at a participating TIA clinic within 4 weeks of a first suspected TIA
• diagnosed with a TIA or 'minor' stroke, due to atherosclerosis or small vessel occlusion (diagnosis based on the TOAST classification system (69)(70), following neurological examination and neuroimaging (32)).

You may not qualify if:

• patients who have experienced more than one TIA and/or stroke
• inability to give informed consent
• presenting after 4 weeks of their first suspected TIA and/or 'minor' stroke
• contra-indication for exercise training, based on guidelines of the American College of Sports Medicine(72)

Sponsors & Collaborators

• Queen's University, Belfast: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (4)

Ulster Hospital

Belfast, Antrim, BT16 1RH, United Kingdom

Location

Royal Group of Hospitals

Belfast, Antrim, United Kingdom

Location

Craigavon Area Hospital

Craigavon, Armagh, BT63 5QQ, United Kingdom

Location

Antrim Area

Antrim, BT41 2RL, United Kingdom

Location

Related Publications (9)

• Heron N, Kee F, Donnelly M, Tully MA, Cupples ME. Systematic review of the use of behaviour change techniques (BCTs) in home-based cardiac rehabilitation programmes for patients with cardiovascular disease--protocol. Syst Rev. 2015 Nov 17;4:164. doi: 10.1186/s13643-015-0149-5.

  PMID: 26577666 BACKGROUND

• Heron N, Kee F, Donnelly M, Cupples ME. Systematic review of rehabilitation programmes initiated within 90 days of a transient ischaemic attack or 'minor' stroke: a protocol. BMJ Open. 2015 Jun 18;5(6):e007849. doi: 10.1136/bmjopen-2015-007849.

  PMID: 26088808 BACKGROUND

• Heron N, Kee F, Cardwell C, Tully MA, Donnelly M, Cupples ME. Secondary prevention lifestyle interventions initiated within 90 days after TIA or 'minor' stroke: a systematic review and meta-analysis of rehabilitation programmes. Br J Gen Pract. 2017 Jan;67(654):e57-e66. doi: 10.3399/bjgp16X688369. Epub 2016 Dec 5.

  PMID: 27919935 BACKGROUND

• Cupples M, Heron N. What to do after cardiac rehabilitation programs: the role of the general practitioner in cardiovascular prevention. Monaldi Arch Chest Dis. 2016 Oct 14;86(1-2):755. doi: 10.4081/monaldi.2016.755.

  PMID: 27748471 BACKGROUND

• Heron N, Kee F, Donnelly M, Cardwell C, Tully MA, Cupples ME. Behaviour change techniques in home-based cardiac rehabilitation: a systematic review. Br J Gen Pract. 2016 Oct;66(651):e747-57. doi: 10.3399/bjgp16X686617. Epub 2016 Aug 1.

  PMID: 27481858 BACKGROUND

• Heron N, Kee F, Mant J, Reilly PM, Cupples M, Tully M, Donnelly M. Stroke Prevention Rehabilitation Intervention Trial of Exercise (SPRITE) - a randomised feasibility study. BMC Cardiovasc Disord. 2017 Dec 12;17(1):290. doi: 10.1186/s12872-017-0717-9.

  PMID: 29233087 RESULT

• Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.

  PMID: 34813082 DERIVED

• Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.

  PMID: 34184251 DERIVED

• Heron N. Optimising secondary prevention in the acute period following a TIA of ischaemic origin. BMJ Open Sport Exerc Med. 2017 Jan 6;2(1):e000161. doi: 10.1136/bmjsem-2016-000161. eCollection 2016.

  PMID: 29616144 DERIVED

MeSH Terms

Conditions

Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Frank Kee, MRCGP, MD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Public Health

Model Details: The intervention groups will be getting access to a home-based rehabilitation, 'The Healthy Brain Rehabilitation Manual', telephone follow-up with either a GP or stroke nurse and a pedometer.

Study Record Dates

• First Submitted: February 28, 2016
• First Posted: March 18, 2016
• Study Start: March 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: March 1, 2018
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (4)