U.K. trial Rehabilitation exercise and psychological support after Covid 19 infection (REGAIN) Warwick University

[rvallee]

This is a paper about the fact that they're doing a trial that will be published in a paper?

The idea of taking into account ME and PEM is contradicted by pretty much all the choices that went into this. It's beyond any possible doubt that this BPS stuff is useless. It was invented explicitly on the belief that this is not a real condition, rather a disorder of perception. Or whatever. This is not even disputable.

It's simply an insult to keep on wasting people's lives while pretending this is anything but continuing the same denial and gaslighting that blocked all efforts to help us and ruined millions of lives. They can say whatever they want, it's what they're doing that counts and this is harmful.

 

[RedFox]

"Post exertional malaise

During the development phase, the trial team were contacted by several organisations representing the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) community with concerns relating to the potential harms of unsupervised vigorous exercise for people with long-COVID, in particular the risk of post-exertional malaise18. We recognised the lived experience and expertise within these groups and sought to ensure that REGAIN practitioners were appropriately trained in risks relating to post-exertional malaise. Furthermore, early identification screening measures for post-exertional malaise were incorporated into the intervention protocols, particularly during the initial one-to-one consultation and every subsequent exercise session. Practitioners were encouraged to monitor the progress of participants during and after exercise sessions in order to ensure that exercise intensity and volume were within individuals’ capabilities and did not cause undue persistent fatigue or other problems."

Encouraging. We'll see whether screening for PEM is properly executed. It would be far better to simply exclude people with PEM. Assuming it's actual psychological support and not ME-CBT, it's a bandaid on a bullet hole.

 

[Sean]

Practitioners were encouraged to monitor the progress of participants during and after exercise sessions in order to ensure that exercise intensity and volume were within individuals’ capabilities and did not cause undue persistent fatigue or other problems.

Encouraged?

Hmm.

How about compulsory, independently monitored, and fully transparent to patients before they sign up for the trial?

 

[RedFox]

I didn't notice the word "encouraged" there. In that case, it's just PEM-washing. (Saying they're managing PEM safely without actually doing anything). I hope I'm wrong.
The only ethical way to conduct an exercise study on LC patients is to screen for and exclude people experiencing PEM.

 

[bobbler]

https://openresearch.nihr.ac.uk/articles/3-10

RESEARCH ARTICLE
Clinical trial
Development of an online intervention for the Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) trial
[version 1; peer review: awaiting peer review]

Stuart Ennis1,2, Peter Heine1,2, Harbinder Sandhu1, Bart Sheehan3, Joyce Yeung
1, David McWilliams4, Christina Jones5, Martin Underwood1, Julie Bruce1, Kate Seers6, Gordon McGregor1,2,7

Author details

Abstract

Background:

Up to half of people hospitalised with COVID-19 report diverse and persistent symptoms affecting quality of life for months and sometimes years after discharge (long-COVID). We describe the development of an online group exercise and behavioural support intervention for people who continue to experience such physical and/or emotional health problems more than three months after hospital discharge.

Methods:

Intervention development was informed by the Medical Research Council framework for complex interventions. Our multidisciplinary team of academics, clinicians, and people with long-COVID, had collective expertise in the development and testing of complex interventions. We integrated a bio-psycho-social model of care drawing on rehabilitation literature for long-term health conditions and experiences from our pre-pilot study. Multiple stakeholder meetings were held to refine the intervention which was designed to be deliverable within the UK National Health Service. We adhere to TIDieR guidance for transparent and explicit reporting of telehealth interventions.

Results:

The final REGAIN online exercise and behavioural support intervention consisted of an initial 1:1 consultation with a trained practitioner, followed by eight online group exercise, and six group support, sessions delivered over eight weeks. Participants could also access an online library of on-demand exercise and support videos.

Conclusions:

The final REGAIN intervention, combining exercise and behavioural support, is fully manualised with clear pathways to delivery and implementation. It is currently being tested in a randomised controlled trial. The intervention, developed with extensive patient and stakeholder engagement, could be incorporated into existing NHS rehabilitation programmes, should it prove to be clinically and cost-effective for people with long-COVID.

Trial registration: International Standard Randomised Controlled Trial Number (ISRCTN) 11466448: Rehabilitation exercise and psychological support after COVID-19 infection: REGAIN.

Keywords
rehabilitation, long-COVID, physical activity, online support, intervention development, physical activity

hopefully not too much of a sidenote, I thought it might be interesting context. One of the authors above, Harbinder Sandhu, is in the following article (or maybe advertorial as it is 'in partnership') on Burnout: https://vogue.sg/vogue-salon-breaking-the-burnout-cycle/