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Co-creation of a complex, multicomponent rehabilitation intervention and feasibility trial protocol for the PostUraL tachycardia Syndrome Exercise (PULSE) study
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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 and McGregor, Gordon (2023) Co-creation of a complex, multicomponent rehabilitation intervention and feasibility trial protocol for the PostUraL tachycardia Syndrome Exercise (PULSE) study. Pilot and Feasibility Studies, 9 (1). 143. doi:10.1186/s40814-023-01365-4 ISSN 2055-5784.
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WRAP-Co-creation-complex-multicomponent-rehabilitation-intervention-feasibility-trial-protocol-PostUraL-tachycardia-Syndrome-Exercise-(PULSE)-study-2023.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (1808Kb) | Preview |
Official URL: https://doi.org/10.1186/s40814-023-01365-4
Abstract
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.
Item Type: | Journal Article | |||||||||
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Subjects: | R Medicine > R Medicine (General) R Medicine > RA Public aspects of medicine R Medicine > RC Internal medicine |
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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SWORD Depositor: | Library Publications Router | |||||||||
Library of Congress Subject Headings (LCSH): | Tachycardia , Tachycardia -- Patients -- Rehabilitation, Heart -- Diseases -- Patients -- Rehabilitation , Dysautonomia , Clinical trials, Exercise | |||||||||
Journal or Publication Title: | Pilot and Feasibility Studies | |||||||||
Publisher: | BioMed Central Ltd. | |||||||||
ISSN: | 2055-5784 | |||||||||
Official Date: | 15 August 2023 | |||||||||
Dates: |
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Volume: | 9 | |||||||||
Number: | 1 | |||||||||
Article Number: | 143 | |||||||||
DOI: | 10.1186/s40814-023-01365-4 | |||||||||
Status: | Peer Reviewed | |||||||||
Publication Status: | Published | |||||||||
Access rights to Published version: | Open Access (Creative Commons) | |||||||||
Date of first compliant deposit: | 18 October 2023 | |||||||||
Date of first compliant Open Access: | 20 October 2023 | |||||||||
RIOXX Funder/Project Grant: |
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