CClinicalTrials.gg
Active, not recruitingNCT07569497PREP MaintainUpdated May 6, 2026

Physical Activity Maintenance Intervention for People With Stroke

An interventional study of Physical activity maintenance in Stroke, sponsored by University of Ulster. Active, not recruiting at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by University of Ulster · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The main objective of this study is to understand the perspectives of key stakeholders on the components, structure, and content of a physical activity maintenance intervention, ensuring the intervention is relevant, acceptable, and feasible for all stakeholders. The second objective is to co-design and refine a prototype intervention using an iterative process, actively involving stakeholders in the development and customisation of the intervention to meet their specific needs and preferences. This mixed methods study involving three stages of the DECIPHer co-production include; 1) evidence review/stakeholder consultation, 2) co-production, and 3) prototyping. Stage 1 will consist of multiple focus groups of Post Rehabilitation Exercise Programme (PREP) participants, staff, and health care professionals. Stage 2 aims to co-design the content, structure, and materials of the PREP maintenance programme, building on stage 1 data. At least 10 participants; 2 from each stakeholder group i.e. healthcare workers, PREP staff, and PREP participants, who completed stage 1 will be asked to take part in the second stage. The workshops will aim to discuss intervention content, sturcture, and materials. Stage 3 will be the prototype stage where what is developed in stage 2 is brought forward to the post-PREP groups.

02

Conditions studied

  • Stroke

Keywords

  • Physical activity
  • Co-design
03

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's planned enrollment of 34 is below the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University of Ulster is the lead sponsor of 94 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • PREP Participants:

    1. 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).
    2. 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:

    1. Currently working for Northern Ireland Chest Heart and Stroke as a care coordinator role or PREP delivery physiotherapist
    2. Minimum experience of 12 weeks involvement in PREP. Or
    3. 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.)

Exclusion criteria

Exclusion Criteria:

  • PREP Participants:

    1. Unable to participate in a group based conversation.
    2. Carers who have no knowledge or experience of PREP.
    3. Unable to use/access a digital device with internet access and a microphone (for online focus group only).
    4. Being a member of the advisory board
  • PREP Staff/Health care workers:

    1. Experience of supporting people with stroke to complete physical activity within the acute hospital setting only.
    2. Unable to use/access a digital device with internet access and a microphone (for online focus group only).
    3. Being a member of the advisory board
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (estimated)

Study arms

  • Experimental
    Cohort

    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

  • OtherPhysical activity maintenance

    Co-designed PA maintenance program

06

What researchers measure

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

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

07

Study locations

2 sites
  • Ulster University
    Belfast, BT15 1ED, United Kingdom
  • Ulster University
    Belfast, United Kingdom
08

References and documents

Publications

  • 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. PubMed 31236480 ↗
  • 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. PubMed 37353847 ↗
  • 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. PubMed 22300728 ↗
  • 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. PubMed 26257146 ↗
  • 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. PubMed 36123973 ↗
  • 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. PubMed 31011851 ↗
  • 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. PubMed 30051462 ↗
  • 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. PubMed 32196635 ↗
  • 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. PubMed 30689666 ↗
  • 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. PubMed 32380998 ↗
  • 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. PubMed 17074863 ↗
  • 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. PubMed 28870192 ↗
  • 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. PubMed 33241533 ↗
  • 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. PubMed 36707269 ↗
  • 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. PubMed 33745454 ↗
  • 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. PubMed 28860726 ↗
  • 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. PubMed 25082472 ↗
  • 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. PubMed 24389402 ↗
  • 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. PubMed 10709946 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07569497
Lead sponsor
University of Ulster
Collaborators
Northern Ireland Chest Heart and Stroke
Responsible party
Katy Pedlow (Senior lecturer in Physiotherapy, University of Ulster) — Principal investigator
First posted
May 6, 2026
Start date
Dec 12, 2024
Primary completion
Jul 4, 2026 (estimated)
Completion
Aug 28, 2026 (estimated)
Last update
May 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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