We aim to assess the feasibility of a supervised exercise rehabilitation intervention with behavioural and motivational support, compared to best practice usual care, for people with PoTS. We will enrol people with PoTS on a randomised feasibility trial, test physiological and health-related outcome measures, and explore participant experience. This study has four objectives:
1. Finalise the pathway to exercise rehabilitation: People with PoTS are not routinely referred for exercise rehabilitation. We will screen all people with PoTS attending syncope outpatient clinics at two hospitals during a three-month period. This will allow us to fully understand the clinical pathway from diagnosis and treatment, to exercise rehabilitation. We will refine and finalise screening and recruitment procedures, and the inclusion/exclusion criteria for a randomised feasibility study.
2. Refine/finalise an exercise rehabilitation intervention: Building on existing evidence and pilot experience from our centres, we will refine and finalise the Postural Tachycardia Syndrome Exercise (PULSE) intervention and delivery model. Using co-production, we will extensively involve people affected by PoTS, and relevant stakeholders, in refining the intervention.
3. Undertake a randomised feasibility study: 62 participants (31 intervention, 31 control) will be randomised to the PULSE intervention or usual care. Process-related measures will include eligibility, recruitment, and intervention and outcome measure adherence. Physiological, clinical and health related measures will include the short physical performance battery, increase in heart rate from supine to 10-minute stand, and quality of life.
4. Conduct a qualitative analysis: To explore perceptions, opinions, acceptability and experiences of trial procedures, the PULSE intervention, and outcome measures, we will interview a sample of participants who finish the study, participants who drop-out, and those who declined participation.
Who is eligible for the PulSE study?
Only adults with a formal diagnosis of PoTS will be eligible. Other criteria will be agreed during three months of stakeholder engagement and co-production meetings. People affected by PoTS, and other stakeholders, will work directly with the research team to agree the eligibility criteria.