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Protocol for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome : the PULSE study
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McGregor, Gordon, Hee, Siew Wan, Eftekhari, Helen, Holliday, Nikki, Pearce, Gemma, Sandhu, Harbinder, Simmonds, Jane, Joshi, Shivam, Kavi, Lesley, Bruce, Julie, Panikker, Sandeep, Lim, Boon and Hayat, Sajad (2020) Protocol for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome : the PULSE study. Protocol for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study, 6 . 157 . doi:10.1186/s40814-020-00702-1
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WRAP-protocol-randomised-controlled-feasibility-trial-exercise-rehabilitation-peoplepostural-tachycardia-syndrome-Bruce-2020.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (801Kb) | Preview |
Official URL: https://doi.org/10.1186/s40814-020-00702-1
Abstract
Background:
Postural orthostatic tachycardia syndrome (POTS) is an autonomic nervous system disorder causing an abnormal cardiovascular response to upright posture. It affects around 0.2% of the population, most commonly women aged 13 to 50 years. POTS can be debilitating; prolonged episodes of pre-syncope and fatigue can severely affect activities of daily living and health-related quality of life (HRQoL). Medical treatment is limited and not supported by randomised controlled trial (RCT) evidence. Lifestyle interventions are first-line treatment, including increased fluid and salt intake, compression tights and isometric counter-pressure manoeuvres to prevent fainting. Observational studies and small RCTs suggest exercise training may improve symptoms and HRQoL in POTS, but evidence quality is low.
Methods:
Sixty-two people (aged 18–40 years) with a confirmed diagnosis of POTS will be invited to enrol on a feasibility RCT with embedded qualitative study. The primary outcome will be feasibility; process-related measures will include the number of people eligible, recruited, randomised and withdrawn, along with indicators of exercise programme adherence and acceptability. Secondary physiological, clinical and health-related outcomes including sub-maximal recumbent bike exercise test, active stand test and HRQoL will be measured at 4 and 7 months post-randomisation by researchers blinded to treatment allocation. The PostUraL tachycardia Syndrome Exercise (PULSE) intervention consists of (1) individual assessment; (2) 12-week, once to twice-weekly, supervised out-patient exercise training; (3) behavioural and motivational support; and (4) guided lifestyle physical activity. The control intervention will be best-practice usual care with a single 30-min, one-to-one practitioner appointment, and general advice on safe and effective physical activity. For the embedded qualitative study, participants (n = 10 intervention, n = 10 control) will be interviewed at baseline and 4 months post-randomisation to assess acceptability and the feasibility of progressing to a definitive trial.
Discussion:
There is very little high-quality research investigating exercise rehabilitation for people with POTS. The PULSE study will be the first randomised trial to assess the feasibility of conducting a definitive multicentre RCT testing supervised 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 > R Medicine (General) R Medicine > RC Internal medicine R Medicine > RJ Pediatrics |
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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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| Library of Congress Subject Headings (LCSH): | Posture disorders, Posture disorders -- Exercise therapy, Dysautonomia, Autonomic nervous system -- Diseases, Standing position -- Health aspects, Heart -- Diseases -- Patients -- Rehabilitation , Clinical trials | |||||||||
| Journal or Publication Title: | Protocol for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study | |||||||||
| Publisher: | Pilot and Feasibility Studies | |||||||||
| Official Date: | 19 October 2020 | |||||||||
| Dates: |
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| Volume: | 6 | |||||||||
| Article Number: | 157 | |||||||||
| DOI: | 10.1186/s40814-020-00702-1 | |||||||||
| Status: | Peer Reviewed | |||||||||
| Publication Status: | Published | |||||||||
| Access rights to Published version: | Open Access (Creative Commons) | |||||||||
| Date of first compliant deposit: | 23 October 2020 | |||||||||
| Date of first compliant Open Access: | 27 October 2020 | |||||||||
| RIOXX Funder/Project Grant: |
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