Physical Activity Maintenance Intervention for People With Stroke (PREP Maintain)
28 aprile 2026 aggiornato da: Katy Pedlow, University of Ulster
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.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
34
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Belfast, Regno Unito
- Ulster University
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Belfast, Regno Unito, BT15 1ED
- Ulster University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
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.)
Exclusion Criteria:
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
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Co-designed PA maintenance program
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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International Physical Activity Questionnaire short form
Lasso di tempo: Baseline (pre intervention), post intervention (week 6) and 3 months post intervention completion
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Self report questionnaire measuring physical activity levels related to low, moderate and high intensity activity and amount of time sitting
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Baseline (pre intervention), post intervention (week 6) and 3 months post intervention completion
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
12 dicembre 2024
Completamento primario (Stimato)
4 luglio 2026
Completamento dello studio (Stimato)
28 agosto 2026
Date di iscrizione allo studio
Primo inviato
27 gennaio 2025
Primo inviato che soddisfa i criteri di controllo qualità
28 aprile 2026
Primo Inserito (Effettivo)
6 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
6 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
28 aprile 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- REC/24/0044
- FCNUR-24-062 (Altro identificatore: Ulster University)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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