| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | 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 Hayat, Sajad |
| 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will be feasibility; process-related measures will include the number of people eligible, recruited, randomised and withdrawn, along with indicators of exercise programme adherence and acceptability.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. |
| Related Links | https://pilotfeasibilitystudies.biomedcentral.com/counter/pdf/10.1186/s40814-020-00702-1.pdf |
| Ending Page | 11 |
| Page Count | 11 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| ISSN | 20555784 |
| DOI | 10.1186/s40814-020-00702-1 |
| Journal | Pilot and Feasibility Studies |
| Issue Number | 1 |
| Volume Number | 6 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2020-10-19 |
| Access Restriction | Open |
| Subject Keyword | Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences Postural orthostatic tachycardia syndrome Exercise Rehabilitation Dysautonomia Cardiac rehabilitation Randomised controlled trial Complex intervention Feasibility Medicine/Public Health |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine |
| Journal Impact Factor | 1.5/2023 |
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