Physical Activity Maintenance Intervention for People With Stroke (PREP Maintain)
28. april 2026 opdateret af: 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.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
34
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Belfast, Det Forenede Kongerige
- Ulster University
-
Belfast, Det Forenede Kongerige, BT15 1ED
- Ulster University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Co-designed PA maintenance program
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
International Physical Activity Questionnaire short form
Tidsramme: 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
|
Baseline (pre intervention), post intervention (week 6) and 3 months post intervention completion
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
12. december 2024
Primær færdiggørelse (Anslået)
4. juli 2026
Studieafslutning (Anslået)
28. august 2026
Datoer for studieregistrering
Først indsendt
27. januar 2025
Først indsendt, der opfyldte QC-kriterier
28. april 2026
Først opslået (Faktiske)
6. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. april 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- REC/24/0044
- FCNUR-24-062 (Anden identifikator: Ulster University)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Physical activity maintenance
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RekrutteringFysisk aktivitet | Insulin resistens | Pubertet | PCOS (polycystisk ovariesyndrom)Forenede Stater
-
University of Vic - Central University of CataloniaIRIS-CC; AGAURAktiv, ikke rekrutterendePsykisk sundhedsproblemSpanien
-
Wake Forest University Health SciencesNational Heart, Lung, and Blood Institute (NHLBI)AfsluttetFysisk aktivitetForenede Stater
-
The Miriam HospitalUkendtSlag | Stillesiddende livsstil | Iskæmisk angreb, forbigående | Dyrke motionForenede Stater
-
Centre Hospitalier Universitaire de Saint EtienneNational Cancer Institute, FranceAfsluttetKræft prostataFrankrig
-
The University of Hong KongRekrutteringDemens | Plejerbyrde | Kognitiv svækkelse, mild | Demens, mildHong Kong
-
Northeastern UniversitySociety for Pediatric Psychology; APA: American Psychological AssociationRekrutteringAutismespektrumforstyrrelse (ASD)Forenede Stater
-
Cairo UniversityTilmelding efter invitation
-
IVI BilbaoInstituto Valenciano de Infertilidad, IVI VALENCIAAfsluttet