StrokePREP MaintainNCT07569497
Physical Activity Maintenance Intervention for People With Stroke
A study testing Physical activity maintenance in people with Stroke, run by University of Ulster at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Physical activity maintenance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 12 Dec 2024to 28 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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:
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Ulster University
Belfast, BT15 1ED
Ulster University
Belfast
About this study
Official title: Co-design of a Physical Activity Maintenance Intervention for People With Stroke
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.
- Conditions
- Stroke
- Being tested
- Physical activity maintenance
- Keywords
- Physical activity, Co-design
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity maintenanceOther
Co-designed PA maintenance program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Physical activity maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (pre intervention), post intervention (week 6) and 3 months post intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start12 Dec 2024
- Primary completion4 Jul 2026 (estimated)
- Study completion28 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A mixed methods study involving three stages of the DECIPHer co-production framework will occur during this study.
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Ireland Chest Heart and Stroke
- Responsible party
- Principal investigator, Katy Pedlow, University of Ulster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569497
- Sponsor's protocol ID
- REC/24/0044
- Other IDs
- FCNUR-24-062
- Acronym
- PREP Maintain
- Status last verified
- Apr 2026
- First submitted
- 27 Jan 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 31236480Irvine 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 37353847Patterson 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 22300728English 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 26257146Shrivastav 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 36123973Kramer 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 31011851Lynch 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 30051462Saunders 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 32196635Yeoh 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 30689666Williams 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 32380998Bate 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 17074863Hawkins 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 28870192Morovatdar 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 33241533Mead 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 36707269Reynolds 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
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-design of a Physical Activity Maintenance Intervention for People With Stroke
- ClinicalTrials.gov ID
- NCT07569497
- Acronym / sponsor ID
- PREP Maintain / REC/24/0044
- Conditions
- Stroke
- Keywords
- Physical activity, Co-design
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Northern Ireland Chest Heart and Stroke
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 4 Jul 2026 (estimated)
- Study completion
- 28 Aug 2026 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A mixed methods study involving three stages of the DECIPHer co-production framework will occur during this study.
| Arm | Type | Receives |
|---|---|---|
| Cohort | Experimental | Other: Physical activity maintenanceA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- PREP Participants:
- PREP Staff/Health Care workers:
Key exclusion criteria (9 listed)
- PREP Participants:
- PREP Staff/Health care workers:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity maintenanceCo-designed PA maintenance program | Other | Cohort |
Primary outcome
International Physical Activity Questionnaire short form
Time frame: Baseline (pre intervention), post intervention (week 6) and 3 months post intervention completion
Self report questionnaire measuring physical activity levels related to low, moderate and high intensity activity and amount of time sitting
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background: PubMed 31236480Norrving 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.
- Background: PubMed 37353847Irvine 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.
- Background: PubMed 22300728Patterson 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.
- Background: PubMed 26257146English 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.
- Background: PubMed 36123973Shrivastav 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.
- Background: PubMed 31011851Kramer 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.
- Background: PubMed 30051462Lynch 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.
- Background: PubMed 32196635Saunders 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.
- Background: PubMed 30689666Yeoh 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.
- Background: PubMed 32380998Williams 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.
- Background: PubMed 17074863Bate 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.
- Background: PubMed 28870192Hawkins 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.
- Global Health Estimates provides statistics on health problems worldwideLink provided by the sponsor.
- World Stroke Organization: Global Stroke Fact SheetLink provided by the sponsor.
- Web-based implement Toolkit (WIT)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity maintenance in people with Stroke, run by University of Ulster at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Physical Activity Questionnaire short form (time frame: Baseline (pre intervention), post intervention (week 6) and 3 months post intervention completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07569497, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.