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

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https://www.researchsquare.com/article/rs-2642799/v1

Background: There is a dearth of research to support the treatment of people with Postural Tachycardia Syndrome (PoTS). Despite expert consensus suggesting exercise is recommended for this patient group, there are no randomised control trials examining this rigorously. The aim was to co-create a feasibility trial protocol and a rehabilitation intervention for people living with PoTS.

Methods: The intervention and feasibility trial design were co-created as part of the PostUraL tachycardia Syndrome Exercise (PULSE) study. We used the ‘three co’s framework’ of co-define, co-design and co-refine. Recruitment included key national charities and National Health Service Trusts treating people living with PoTS in the United Kingdom.18 Patient and Public Involvement members attended the co-define session, and 16 co-creators with a mix of expertise attended the subsequent co-design and co-refine sessions. Seven intervention practitioners were trained in the rehabilitation intervention, providing feedback for further co-refinement.

Results: The final co-created intervention comprises online physical activity, and lifestyle and behaviour change support sessions. It is based on functional movement activities using a patient-centred approach tailored to individual needs. Physical activity intensity is guided by individuals’ perception of effort rather than by objective measures. Recumbent bikes are provided for home use. Patients deemed randomisation to be acceptable because research in this area was considered important.

Conclusions: An innovative approach was used to co-create the PULSE intervention and feasibility trial protocol to meet the evidence-based and logistical needs of people living with PoTS, clinicians, service deliverers, third sector organisations, academics and funders. This can be used as a successful example and template for future research internationally. People living with PoTS were recognised as experts and involved in every aspect of conceptualisation, design and refinement. This complex rehabilitation intervention is currently being tested in a randomised feasibility trial comparing the PULSE intervention with best-practice usual care for people living with PoTS.

 

"Broadly, co-creators agreed with the inclusion and exclusion criteria for the trial. It was agreed that people experiencing chronic fatigue should be included, as long as fatigue was carefully monitored and managed during the trial, with particular attention to identifying and avoiding post-exertional malaise"

 

With my POTs, just standing up increases my heart rate to over 80% of the safe maximum according to this chart -

https://www.allinahealth.org/health...e/measuring-how-your-heart-reacts-to-exercise

It never goes be1ow this if I'm doing any activity requiring standing, such as making a cup of tea, feeding the cats, hanging up washing etc. So I'm 'exercising at an intense 1eve1' whenever I'm not 1ying down (sitting a1so raises my pu1se rate significant1y). I 1ive a1one and don't have anyone come to do anything for me, so it's hard to see how I can be deconditioned despite having severe ME (90% bedbound, 100% housebound for severa1 years now) since I'm having to do short bursts of 'intense activity' throughout the day.

 

Is the aim to reduce patients' POTs symptoms (i.e. to reduce their increase in pu1se rate on standing)? Nothing is mentioned, it just seems 1ike the purpose is to get them to exercise more...

 

Horrifying.

 

To people who think that POTS is just a version of deconditioning, or whatever, they are the same goal.

It's truly absurd how little medicine understands about deconditioning when you add all this up. It may as well be nothing at all.

 

To be fair to my own GP, we were going to try medication for it (e.g. tria11ing beta b1ockers initia11y) but then the pandemic happened. After that I've had a 1ot of other medica1 conditions that have de-prioritised getting the POTs investigated further.