NCT07569497

Brief Summary

Most people living with stroke engage in low levels of physical activity putting them at higher risk of having a second stroke and developing a range of chronic health conditions. Despite their desire to participate in physical activity, numerous barriers exist. Whilst Northern Ireland Chest Heart and Stroke has successfully implemented the Post Rehabilitation Exercise Programme, the challenge arises post-completion, as survivors of stroke struggle to sustain physical activity over the longer term. This study aims to design and test an intervention to support physical activity in the longer term.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
4mo left

Started Dec 2024

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Dec 2024Aug 2026

Study Start

First participant enrolled

December 12, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2025

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2026

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

January 27, 2025

Last Update Submit

April 28, 2026

Conditions

Keywords

Physical activityCo-design

Outcome Measures

Primary Outcomes (1)

  • International Physical Activity Questionnaire short form

    Self report questionnaire measuring physical activity levels related to low, moderate and high intensity activity and amount of time sitting

    Baseline (pre intervention), post intervention (week 6) and 3 months post intervention completion

Study Arms (1)

Cohort

EXPERIMENTAL

A group of stakeholders (people living with stroke, carers, therapists and health and fitness professionals) will co-design a physical activity maintenance program. This will then be trialled with a cohort of stroke survivors.

Other: Physical activity maintenance

Interventions

Co-designed PA maintenance program

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PREP Participants:
  • Adults 18 years and older with a clinical diagnosis of stroke, currently attending PREP or completed PREP. Adults with communication impairment will be able to participate via alternative methods of communication (e.g., assistive communication device).
  • Carers who have supported an adult who have a clinical diagnosis of stroke to complete PREP either currently or have completed PREP.
  • PREP Staff/Health Care workers:
  • Currently working for Northern Ireland Chest Heart and Stroke as a care coordinator role or PREP delivery physiotherapist
  • Minimum experience of 12 weeks involvement in PREP. Or
  • Have experience of supporting people with stroke to complete physical activity within the community setting e.g exercise, health, voluntary and statutory organization staff. (There is no minimum amount of experience required (i.e. even if they have supported one person, they can still participate) and therefore there is no additional criteria required for these subjects.)

You may not qualify if:

  • PREP Participants:
  • Unable to participate in a group based conversation.
  • Carers who have no knowledge or experience of PREP.
  • Unable to use/access a digital device with internet access and a microphone (for online focus group only).
  • Being a member of the advisory board
  • PREP Staff/Health care workers:
  • Experience of supporting people with stroke to complete physical activity within the acute hospital setting only.
  • Unable to use/access a digital device with internet access and a microphone (for online focus group only).
  • Being a member of the advisory board

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ulster University

Belfast, BT15 1ED, United Kingdom

Location

Ulster University

Belfast, United Kingdom

Location

Related Publications (19)

  • Norrving B, Barrick J, Davalos A, Dichgans M, Cordonnier C, Guekht A, Kutluk K, Mikulik R, Wardlaw J, Richard E, Nabavi D, Molina C, Bath PM, Stibrant Sunnerhagen K, Rudd A, Drummond A, Planas A, Caso V. Action Plan for Stroke in Europe 2018-2030. Eur Stroke J. 2018 Dec;3(4):309-336. doi: 10.1177/2396987318808719. Epub 2018 Oct 29.

    PMID: 31236480BACKGROUND
  • Irvine L, Morris JH, Dombrowski SU, Breckenridge JP, Farre A, Ozakinci G, Lebedis T, Jones C. Keeping Active with Texting after Stroke (KATS): development of a text message intervention to promote physical activity and exercise after stroke. Pilot Feasibility Stud. 2023 Jun 23;9(1):105. doi: 10.1186/s40814-023-01326-x.

    PMID: 37353847BACKGROUND
  • Patterson KK, Nadkarni NK, Black SE, McIlroy WE. Gait symmetry and velocity differ in their relationship to age. Gait Posture. 2012 Apr;35(4):590-4. doi: 10.1016/j.gaitpost.2011.11.030. Epub 2012 Jan 31.

    PMID: 22300728BACKGROUND
  • English C, Healy GN, Coates A, Lewis LK, Olds T, Bernhardt J. Sitting time and physical activity after stroke: physical ability is only part of the story. Top Stroke Rehabil. 2016 Feb;23(1):36-42. doi: 10.1179/1945511915Y.0000000009. Epub 2015 Aug 10.

    PMID: 26257146BACKGROUND
  • Shrivastav SR, Ciol MA, Lee D. Perceived Community Participation and Associated Factors in People With Stroke. Arch Rehabil Res Clin Transl. 2022 Jul 16;4(3):100210. doi: 10.1016/j.arrct.2022.100210. eCollection 2022 Sep.

    PMID: 36123973BACKGROUND
  • Kramer SF, Hung SH, Brodtmann A. The Impact of Physical Activity Before and After Stroke on Stroke Risk and Recovery: a Narrative Review. Curr Neurol Neurosci Rep. 2019 Apr 22;19(6):28. doi: 10.1007/s11910-019-0949-4.

    PMID: 31011851BACKGROUND
  • Lynch EA, Jones TM, Simpson DB, Fini NA, Kuys SS, Borschmann K, Kramer S, Johnson L, Callisaya ML, Mahendran N, Janssen H, English C; ACTIOnS Collaboration. Activity monitors for increasing physical activity in adult stroke survivors. Cochrane Database Syst Rev. 2018 Jul 27;7(7):CD012543. doi: 10.1002/14651858.CD012543.pub2.

    PMID: 30051462BACKGROUND
  • Saunders DH, Sanderson M, Hayes S, Johnson L, Kramer S, Carter DD, Jarvis H, Brazzelli M, Mead GE. Physical fitness training for stroke patients. Cochrane Database Syst Rev. 2020 Mar 20;3(3):CD003316. doi: 10.1002/14651858.CD003316.pub7.

    PMID: 32196635BACKGROUND
  • Yeoh YS, Koh GC, Tan CS, Tu TM, Singh R, Chang HM, De Silva DA, Ng YS, Ang YH, Yap P, Chew E, Merchant RA, Yeo TT, Chou N, Venketasubramanian N, Lee KE, Young SH, Hoenig H, Matchar DB, Luo N. Health-related quality of life loss associated with first-time stroke. PLoS One. 2019 Jan 28;14(1):e0211493. doi: 10.1371/journal.pone.0211493. eCollection 2019.

    PMID: 30689666BACKGROUND
  • Williams O, Sarre S, Papoulias SC, Knowles S, Robert G, Beresford P, Rose D, Carr S, Kaur M, Palmer VJ. Lost in the shadows: reflections on the dark side of co-production. Health Res Policy Syst. 2020 May 7;18(1):43. doi: 10.1186/s12961-020-00558-0.

    PMID: 32380998BACKGROUND
  • Bate P, Robert G. Experience-based design: from redesigning the system around the patient to co-designing services with the patient. Qual Saf Health Care. 2006 Oct;15(5):307-10. doi: 10.1136/qshc.2005.016527.

    PMID: 17074863BACKGROUND
  • Hawkins J, Madden K, Fletcher A, Midgley L, Grant A, Cox G, Moore L, Campbell R, Murphy S, Bonell C, White J. Development of a framework for the co-production and prototyping of public health interventions. BMC Public Health. 2017 Sep 4;17(1):689. doi: 10.1186/s12889-017-4695-8.

    PMID: 28870192BACKGROUND
  • Morovatdar N, Di Napoli M, Stranges S, Thrift AG, Kapral M, Behrouz R, Farzadfard MT, Andalibi MSS, Oskooie RR, Sawant A, Mokhber N, Azarpazhooh MR. Regular physical activity postpones age of occurrence of first-ever stroke and improves long-term outcomes. Neurol Sci. 2021 Aug;42(8):3203-3210. doi: 10.1007/s10072-020-04903-7. Epub 2020 Nov 25.

    PMID: 33241533BACKGROUND
  • Mead GE. Physical fitness training after stroke-a crucial and exciting field for service development and research. J Stroke Cerebrovasc Dis. 2023 Apr;32(4):106991. doi: 10.1016/j.jstrokecerebrovasdis.2023.106991. Epub 2023 Jan 25. No abstract available.

    PMID: 36707269BACKGROUND
  • Reynolds H, Steinfort S, Tillyard J, Ellis S, Hayes A, Hanson ED, Wijeratne T, Skinner EH. Feasibility and adherence to moderate intensity cardiovascular fitness training following stroke: a pilot randomized controlled trial. BMC Neurol. 2021 Mar 22;21(1):132. doi: 10.1186/s12883-021-02052-8.

    PMID: 33745454BACKGROUND
  • Yao M, Chen J, Jing J, Sheng H, Tan X, Jin J. Defining the rehabilitation adherence curve and adherence phases of stroke patients: an observational study. Patient Prefer Adherence. 2017 Aug 21;11:1435-1441. doi: 10.2147/PPA.S139854. eCollection 2017.

    PMID: 28860726BACKGROUND
  • Poltawski L, Boddy K, Forster A, Goodwin VA, Pavey AC, Dean S. Motivators for uptake and maintenance of exercise: perceptions of long-term stroke survivors and implications for design of exercise programmes. Disabil Rehabil. 2015;37(9):795-801. doi: 10.3109/09638288.2014.946154. Epub 2014 Aug 1.

    PMID: 25082472BACKGROUND
  • Morris JH, Macgillivray S, McFarlane S. Interventions to promote long-term participation in physical activity after stroke: a systematic review of the literature. Arch Phys Med Rehabil. 2014 May;95(5):956-67. doi: 10.1016/j.apmr.2013.12.016. Epub 2014 Jan 1.

    PMID: 24389402BACKGROUND
  • Marcus BH, Dubbert PM, Forsyth LH, McKenzie TL, Stone EJ, Dunn AL, Blair SN. Physical activity behavior change: issues in adoption and maintenance. Health Psychol. 2000 Jan;19(1S):32-41. doi: 10.1037/0278-6133.19.suppl1.32.

    PMID: 10709946BACKGROUND

Related Links

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A mixed methods study involving three stages of the DECIPHer co-production framework will occur during this study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior lecturer in Physiotherapy

Study Record Dates

First Submitted

January 27, 2025

First Posted

May 6, 2026

Study Start

December 12, 2024

Primary Completion (Estimated)

July 4, 2026

Study Completion (Estimated)

August 28, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations