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

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 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.

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

“…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.…”

“…Underpinned by a participatory action research (24)(25)(26) and design thinking approach (27) (28), this project aimed to design and develop a complex rehabilitation intervention and feasibility trial protocol for people living with PoTS. This co-creation project was the rst stage of the PostUraL tachycardia Syndrome Exercise (PULSE) study, which ultimately aims to investigate the feasibility of conducting a multi-centre RCT testing a comprehensive cocreated exercise rehabilitation intervention for people living with PoTS, compared to best practice usual care (29) (30).…”

Postural orthostatic tachycardia syndrome and other related dysautonomic disorders after SARS-CoV-2 infection and after COVID-19 messenger RNA vaccination

“…In the case of POTS related to SARS-CoV-2 infection, published cases have supported the recommendation of various non-pharmacological interventions, such as increased salt and fluid intake (unless contraindicated), waist-high compression garments, and regular and graduate-supervised exercises ( 84 , 85 ). The utility of an exercise program in a recumbent or semi-recumbent position (rowing or cycling) for 8 weeks, followed by a subsequent 4-week jogging phase, has been demonstrated ( 86 ).…”

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

“…Underpinned by a participatory action research [ 24 – 26 ] and design thinking approach [ 27 , 28 ], this project aimed to design and develop a complex rehabilitation intervention and feasibility trial protocol for people living with PoTS. This co-creation project was the first stage of the PostUraL tachycardia Syndrome Exercise (PULSE) study, with future stages of this research programme aiming to investigate the feasibility of conducting a multi-centre RCT testing the comprehensive co-created exercise rehabilitation intervention for people living with PoTS, compared to best practice usual care [ 29 , 30 ].…”

“…Guidance was used for reporting feasibility development [ 33 ] and maximising the use of qualitative approaches by embracing the iterative and dynamic nature of intervention development [ 34 ]. Detail relating to the template for intervention description and replication (TIDieR) [ 35 ], and the Consensus on Exercise Reporting Template (CERT) [ 36 ] 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.…”