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Co-creation of a complex, multicomponent rehabilitation intervention and feasibility trial protocol for the PostUraL tachycardia Syndrome Exercise (PULSE) study

BACKGROUND: There is a dearth of research to support the treatment of people with postural tachycardia syndrome (PoTS). Despite expert consensus suggesting exercise is recommended for this patient group, there are no randomised control trials examining this rigorously. The aim was to co-create a fea...

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Autores principales: Pearce, Gemma, Holliday, Nikki, Sandhu, Harbinder, Eftekhari, Helen, Bruce, Julie, Timms, Emma, Ablett, Laura, Kavi, Lesley, Simmonds, Jane, Evans, Rebecca, Magee, Paul, Powell, Richard, Keogh, Shane, McGregor, Gordon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10426060/
https://www.ncbi.nlm.nih.gov/pubmed/37582801
http://dx.doi.org/10.1186/s40814-023-01365-4
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author Pearce, Gemma
Holliday, Nikki
Sandhu, Harbinder
Eftekhari, Helen
Bruce, Julie
Timms, Emma
Ablett, Laura
Kavi, Lesley
Simmonds, Jane
Evans, Rebecca
Magee, Paul
Powell, Richard
Keogh, Shane
McGregor, Gordon
author_facet Pearce, Gemma
Holliday, Nikki
Sandhu, Harbinder
Eftekhari, Helen
Bruce, Julie
Timms, Emma
Ablett, Laura
Kavi, Lesley
Simmonds, Jane
Evans, Rebecca
Magee, Paul
Powell, Richard
Keogh, Shane
McGregor, Gordon
author_sort Pearce, Gemma
collection PubMed
description BACKGROUND: There is a dearth of research to support the treatment of people with postural tachycardia syndrome (PoTS). Despite expert consensus suggesting exercise is recommended for this patient group, there are no randomised control trials examining this rigorously. The aim was to co-create a feasibility trial protocol and a rehabilitation intervention for people living with PoTS. METHODS: The intervention and feasibility trial design were co-created as part of the PostUraL tachycardia Syndrome Exercise (PULSE) study. We used the ‘three co’s framework’ of co-define, co-design and co-refine. Recruitment included key national charities and National Health Service Trusts treating people living with PoTS in the UK. Eighteen patient and public involvement members attended the co-define session, and 16 co-creators with a mix of expertise attended the subsequent co-design and co-refine sessions. Seven intervention practitioners were trained in the rehabilitation intervention, providing feedback for further co-refinement. RESULTS: The final co-created intervention comprises online physical activity, and lifestyle and behaviour change support sessions. It is based on functional movement activities using a patient-centred approach tailored to individual needs. Physical activity intensity is guided by individuals’ perception of effort rather than by objective measures. Recumbent bikes are provided for home use. Patients deemed randomisation to be acceptable because research in this area was considered important. CONCLUSIONS: An innovative approach was used to co-create the PULSE intervention and feasibility trial protocol to meet the evidence-based and logistical needs of people living with PoTS, clinicians, service deliverers, third-sector organisations, academics and funders. This can be used as a successful example and template for future research internationally. People living with PoTS were recognised as experts and involved in every aspect of conceptualisation, design and refinement. This complex rehabilitation intervention is currently being tested in a randomised feasibility trial comparing the PULSE intervention with best-practice usual care for people living with PoTS. TRIAL REGISTRATION: ISRCTN45323485 was registered on April 7, 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-023-01365-4.
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spelling pubmed-104260602023-08-16 Co-creation of a complex, multicomponent rehabilitation intervention and feasibility trial protocol for the PostUraL tachycardia Syndrome Exercise (PULSE) study Pearce, Gemma Holliday, Nikki Sandhu, Harbinder Eftekhari, Helen Bruce, Julie Timms, Emma Ablett, Laura Kavi, Lesley Simmonds, Jane Evans, Rebecca Magee, Paul Powell, Richard Keogh, Shane McGregor, Gordon Pilot Feasibility Stud Research BACKGROUND: There is a dearth of research to support the treatment of people with postural tachycardia syndrome (PoTS). Despite expert consensus suggesting exercise is recommended for this patient group, there are no randomised control trials examining this rigorously. The aim was to co-create a feasibility trial protocol and a rehabilitation intervention for people living with PoTS. METHODS: The intervention and feasibility trial design were co-created as part of the PostUraL tachycardia Syndrome Exercise (PULSE) study. We used the ‘three co’s framework’ of co-define, co-design and co-refine. Recruitment included key national charities and National Health Service Trusts treating people living with PoTS in the UK. Eighteen patient and public involvement members attended the co-define session, and 16 co-creators with a mix of expertise attended the subsequent co-design and co-refine sessions. Seven intervention practitioners were trained in the rehabilitation intervention, providing feedback for further co-refinement. RESULTS: The final co-created intervention comprises online physical activity, and lifestyle and behaviour change support sessions. It is based on functional movement activities using a patient-centred approach tailored to individual needs. Physical activity intensity is guided by individuals’ perception of effort rather than by objective measures. Recumbent bikes are provided for home use. Patients deemed randomisation to be acceptable because research in this area was considered important. CONCLUSIONS: An innovative approach was used to co-create the PULSE intervention and feasibility trial protocol to meet the evidence-based and logistical needs of people living with PoTS, clinicians, service deliverers, third-sector organisations, academics and funders. This can be used as a successful example and template for future research internationally. People living with PoTS were recognised as experts and involved in every aspect of conceptualisation, design and refinement. This complex rehabilitation intervention is currently being tested in a randomised feasibility trial comparing the PULSE intervention with best-practice usual care for people living with PoTS. TRIAL REGISTRATION: ISRCTN45323485 was registered on April 7, 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-023-01365-4. BioMed Central 2023-08-15 /pmc/articles/PMC10426060/ /pubmed/37582801 http://dx.doi.org/10.1186/s40814-023-01365-4 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Pearce, Gemma
Holliday, Nikki
Sandhu, Harbinder
Eftekhari, Helen
Bruce, Julie
Timms, Emma
Ablett, Laura
Kavi, Lesley
Simmonds, Jane
Evans, Rebecca
Magee, Paul
Powell, Richard
Keogh, Shane
McGregor, Gordon
Co-creation of a complex, multicomponent rehabilitation intervention and feasibility trial protocol for the PostUraL tachycardia Syndrome Exercise (PULSE) study
title Co-creation of a complex, multicomponent rehabilitation intervention and feasibility trial protocol for the PostUraL tachycardia Syndrome Exercise (PULSE) study
title_full Co-creation of a complex, multicomponent rehabilitation intervention and feasibility trial protocol for the PostUraL tachycardia Syndrome Exercise (PULSE) study
title_fullStr Co-creation of a complex, multicomponent rehabilitation intervention and feasibility trial protocol for the PostUraL tachycardia Syndrome Exercise (PULSE) study
title_full_unstemmed Co-creation of a complex, multicomponent rehabilitation intervention and feasibility trial protocol for the PostUraL tachycardia Syndrome Exercise (PULSE) study
title_short Co-creation of a complex, multicomponent rehabilitation intervention and feasibility trial protocol for the PostUraL tachycardia Syndrome Exercise (PULSE) study
title_sort co-creation of a complex, multicomponent rehabilitation intervention and feasibility trial protocol for the postural tachycardia syndrome exercise (pulse) study
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10426060/
https://www.ncbi.nlm.nih.gov/pubmed/37582801
http://dx.doi.org/10.1186/s40814-023-01365-4
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