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. 2020 Oct 19:6:157.
doi: 10.1186/s40814-020-00702-1. eCollection 2020.

Protocol for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study

Gordon McGregor  1   2   3 , Siew Wan Hee  4 , Helen Eftekhari  5 , Nikki Holliday  2 , Gemma Pearce  2 , Harbinder Sandhu  3 , Jane Simmonds  6 , Shivam Joshi  7 , Lesley Kavi  8 , Julie Bruce  3 , Sandeep Panikker  5 , Boon Lim  9 , Sajad Hayat  10
Affiliations

Protocol for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study

Gordon McGregor et al. Pilot Feasibility Stud. .

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will be feasibility; process-related measures will include the number of people eligible, recruited, randomised and withdrawn, along with indicators of exercise programme adherence and acceptability.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.

Keywords: Cardiac rehabilitation; Complex intervention; Dysautonomia; Exercise; Feasibility; Postural orthostatic tachycardia syndrome; Randomised controlled trial; Rehabilitation.

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Conflict of interest statement

Competing interestsNone

Figures

Fig. 1
Fig. 1
Study flow chart
Fig. 2
Fig. 2
Schedule of enrolment, interventions and assessments
See this image and copyright information in PMC

References

    1. Sheldon RS, Grubb BP, 2nd, Olshansky B, Shen WK, Calkins H, Brignole M, et al. 2015 heart rhythm society expert consensus statement on the diagnosis and treatment of postural tachycardia syndrome, inappropriate sinus tachycardia, and vasovagal syncope. Heart Rhythm. 2015;12(6):e41–e63. doi: 10.1016/j.hrthm.2015.03.029. - DOI - PMC - PubMed
    1. Freeman R, Wieling W, Axelrod FB, Benditt DG, Benarroch E, Biaggioni I, et al. Consensus statement on the definition of orthostatic hypotension, neurally mediated syncope and the postural tachycardia syndrome. Clin Auton Res. 2011;21(2):69–72. doi: 10.1007/s10286-011-0119-5. - DOI - PubMed
    1. Karas B, Grubb BP, Boehm K, Kip K. The postural orthostatic tachycardia syndrome: a potentially treatable cause of chronic fatigue, exercise intolerance, and cognitive impairment in adolescents. Pacing Clin Electrophysiol. 2000;23(3):344–351. doi: 10.1111/j.1540-8159.2000.tb06760.x. - DOI - PubMed
    1. McDonald C, Koshi S, Busner L, Kavi L, Newton JL. Postural tachycardia syndrome is associated with significant symptoms and functional impairment predominantly affecting young women: a UK perspective. BMJ Open. 2014;4(6):e004127. doi: 10.1136/bmjopen-2013-004127. - DOI - PMC - PubMed
    1. Hakim A, O'Callaghan C, De Wandele I, Stiles L, Pocinki A, Rowe P. Cardiovascular autonomic dysfunction in Ehlers-Danlos syndrome-hypermobile type. Am J Med Genet C: Semin Med Genet. 2017;175(1):168–174. doi: 10.1002/ajmg.c.31543. - DOI - PubMed

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