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Protocol update for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome : the PULSE study
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(2022) Protocol update for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome : the PULSE study. Pilot and Feasibility Studies, 8 (1). 101. doi:10.1186/s40814-022-01056-6 ISSN 2055-5784.
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WRAP-protocol-update-randomised-controlled-feasibility-trial-exercise-rehabilitation-people-postural-tachycardia-syndrome-2022.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (1071Kb) | Preview |
Official URL: https://doi.org/10.1186/s40814-022-01056-6
Abstract
Background: The PULSE (PostUraL tachycardia Syndrome Exercise) study is a randomised controlled trial assessing the feasibility of conducting a multicentre RCT testing supervised exercise rehabilitation with behavioural and motivational support, compared to best-practice usual care, for people with Postural Tachycardia Syndrome (PoTS). The original trial protocol was published in BMC Pilot & Feasibility Studies (accessible at https://doi.org/10.1186/s40814-020-00702-1). The PULSE intervention consists of (1) individual assessment; (2) 12-week, twice-weekly, supervised exercise training; (3) behavioural and motivational support; and (4) guided lifestyle physical activity. The control intervention is best-practice usual care with a single 30-min, one-to-one practitioner appointment, and general advice on safe and effective physical activity. Sixty-two people (aged 18–60 years) with a confirmed diagnosis of PoTS will be invited to enrol on a feasibility RCT with an embedded qualitative study. The primary outcome will be feasibility; process-related measures will include eligibility, recruitment, randomisation and withdrawal rates, along with indicators of exercise programme adherence and acceptability. Secondary physiological, clinical and health-related outcomes will be assessed. In response to the COVID-19 pandemic, here we describe amendments to the trial protocol. Methods: Restrictions imposed by the COVID-19 pandemic meant it was necessary to change the delivery of the PULSE and control interventions. These changes reflected the need to limit the risk of COVID-19 transmission in a clinical population, some of whom were at increased risk of contracting the virus and suffering serious illness. The major change was that the originally intended centre-based PULSE and control interventions would now be delivered remotely on-line. Subsequently, there were minor changes to the participant eligibility criteria. These decisions followed an on-line co-creation session with people affected by PoTS, and relevant public and professional stakeholders. Conclusions: We present an update of the original trial protocol in response to the COVID-19 pandemic. No participants were recruited to the original protocol; thus, results will reflect the on-line delivery of the intervention. PULSE will be the first randomised trial to assess the feasibility of conducting a definitive multi-centre RCT testing supervised on-line exercise rehabilitation with behavioural and motivational support, compared to best-practice usual care, for people with PoTS. Trial registration: ISRCTN45323485 registered on 7 April 2020.
| Item Type: | Journal Article | ||||||
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| Subjects: | R Medicine > RC Internal medicine R Medicine > RM Therapeutics. Pharmacology |
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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 > Health Sciences 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, Dysautonomia, Exercise therapy, Clinical trials, Heart -- Diseases -- Patients -- Rehabilitation | ||||||
| Journal or Publication Title: | Pilot and Feasibility Studies | ||||||
| Publisher: | BioMed Central Ltd. | ||||||
| ISSN: | 2055-5784 | ||||||
| Official Date: | 7 May 2022 | ||||||
| Dates: |
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| Volume: | 8 | ||||||
| Number: | 1 | ||||||
| Article Number: | 101 | ||||||
| DOI: | 10.1186/s40814-022-01056-6 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||
| Date of first compliant deposit: | 9 June 2022 | ||||||
| Date of first compliant Open Access: | 9 June 2022 | ||||||
| RIOXX Funder/Project Grant: |
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