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

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will be feasibility; process-related measures will include the number of people eligible, recruited, randomised and withdrawn, along with indicators of exercise programme adherence and acceptability.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

Co-creation of a complex, multicomponent rehabilitation intervention and feasibility trial protocol for the PostUraL tachycardia Syndrome Exercise (PULSE) study

“…However, others felt that ensuring there were other people with a PoTS diagnosis in the group would increase acceptability and thus adherence to the trial. The physical activity intervention is described in more detail elsewhere (29). Brie y, physical activity will be undertaken in a controlled gym environment with progression staged in response to participant tolerance and symptoms.…”

“…However, it was also argued that being unable to complete the test due to anxiety, symptom severity or physical tness levels would be a measurement in itself. Following this co-re nement session, the feasibility trial protocol was nalised for submission to NHS and Coventry University ethical approval processes (changes to the protocol and intervention from this stage are summarised in additional le 1) and published (29).…”

“…Guidance was used for reporting feasibility development (32) and maximising the use of qualitative approaches by embracing the iterative and dynamic nature of intervention development (33). Detail relating to the template for intervention description and replication (TIDieR) (34), and the Consensus on Exercise Reporting Template (CERT) (35) is provided in the published protocols (29) (30). This co-creation process adds novelty to that information by providing the underpinning reasons as to why and how decisions were made.…”

“…The Covid-19 pandemic, which instigated restrictions on movement and 'social mixing' in the UK intermittently throughout 2020 and 2021, meant that the intervention as originally funded and co-designed, with in-person, centrebased delivery, was no longer possible. To address this issue, an additional online co-re ne session was conducted to discuss adaptation of the original intervention and trial protocol (29) to adhere to COVID-19 guidelines. In total 11 co-creators took part, alongside 4 facilitators.…”

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

“…This update relates to the ‘Protocol for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study’ [ 1 ]. The trial received ethical approval from the East Midlands, Nottingham Research Ethics Committee (20/EM/0077) and Health Research Authority on 3 April 2020.…”