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

Warwick Uni press release from December about this trial, https://warwick.ac.uk/newsandevents...ctured_exercise_benefits_long_covid_patients1

 

They are blatantly lying about the "other studies" that showed benefits from exercise. No such studies exist, they conclude no impact on overall health, the only noticeable thing was slightly improved performance by some on the limited tests used to measure performance, like 6MWT, not controlled to whether this performance was gained at the expense of normal activities, which: duh.

Straight up lying to justify a study that has no merit and will eat 1/4 of the pennies dedicated to a public health crisis, especially as they dare claim this is not about increasing performance, rather about improving overall health, which is precisely what the very limited number of studies they use to justify this, 3 by my count but they don't even dare cite them, showed. No basis for why this is necessary, it only aims to "encourage" people to do various activities, as if people with LC are just confused people who can't figure out how to... do activities. I can't even understand the thought process here, it's too irrational.

The very same has been shown by ongoing LC rehabilitation programs. If the patients do nothing else, they may slightly increase their performance on a very limited test, at the expense of other activities, but it has no impact on ability to function or any measurable benefit.

Lying about health care matters. Absurd. But the NICE guidance on LC guarantees it and so the first year of LC research just has to be fully wasted repeating the same failures all over again, for the same reasons. And one thing I noted is that most, if not all, the physicians who have LC have mentioned they tried GET. Even experiencing it, it made sense to them that even though deconditioning does not explain any of this, it should work.

 

Update from @PhysiosforME

REGAIN trial for Long Covid

https://www.physiosforme.com/post/regain-trial-for-long-covid?postId=6000594ec7b36300185f8797

 

Thank you @PhysiosforME .

Apologies if I missed it but has the trial at that point been altered to include robust (objective outcomes) as primary endpoints?

If I remember correctly, the first trial protocol didn't include objective outcomes at primary endpoints.

 

You beat me to it - thank you for sharing this. We have written to the National Institute for Health Research with our concerns so will keep you posted

 

Hmmmmmmmmm
We shall see

 

As a long suffering lay person, I find this disgusting. It's outrageous that these people are given funding time and again. Funding for support after Covid!

They are just a pick and mix of the interchangeable!

http://wrap.warwick.ac.uk/view/divisions/wrin/2019.default.html

They're stealing money for their childish anacronyms. The whole thing is rigged and it's very disheartening. Thank you for all your effort.

 

#MEAction Discussions With REGAIN Trial Clinicians Led To Staff Training On PEM, https://www.meaction.net/2021/06/11...rial-clinicians-led-to-staff-training-on-pem/

@PhysiosforME

 

Good to know thanks for sharing - obviously the amount of challenge about PEM became too much to ignore!

 

Trial By Error: Can Someone Please Slap a Warning Label on this Exercise-and-Rehab Long Covid Study?

"I’ve been writing for a while about the rush to treat long Covid patients with the outdated and debunked approach long applied to ME/CFS. A major effort to demonstrate that an exercise program can lead to “recovery” from long Covid, sponsored by the University of Warwick and funded with £1.200,000 from the UK’s National Institute for Health Research, is currently recruiting. It goes without saying that the REGAIN study is seriously flawed–as we have come to expect from this type of research."

https://www.virology.ws/2022/03/30/...-on-this-exercise-and-rehab-long-covid-study/

 

Dr Asad Khan
has been vociferous on Twitter re those with LC avoiding this trial.
He's also been vociferous on the ReDIRECT trial where diet is being assessed

Diet and exercise - who knew ?
https://twitter.com/user/status/1479039499950866434

 

Meanwhile, in real life, the most common problem I see on the issue of food is being able to eat enough and losing too much weight as a result. People have to try radical dietary changes without any support from professionals. They struggle to keep food down, while some face the difficulty of being unable to eat either because they can't even sit up, or because it massively raises their heart rate.

And then of course there are those who are struggling to eat because they have had no income for too long and cannot find any support.

I am significantly underweight. Not to the point where it's a problem but it's easy to find evidence that this is utterly foolish and pointless.

 

I've emailed the REGAIN team, politely naturally, to ask a few questions and alert them to some criticisms and publications.

I'll let you know if I get a wee response

 

Trial By Error: More on the REGAIN Trial for Long Covid Patients

"I wrote recently about the problematic REGAIN study from the University of Warwick, which is testing an exercise-and-psychological-rehab program as a treatment for long Covid patients. Unfortunately, neither the protocol nor the participant information sheet, to which participants are referred during the consenting process, mentions the core ME/CFS symptom of post-exertional malaise (PEM), which has also been reported in long Covid.

The FAQ does mention PEM. However, since patients are not required to read the FAQ, there is no guarantee that those currently enrolling in this study will know or have heard anything about this potential risk. Moreover, the FAQ suggests that PEM likely impacts only a “small set” of long Covid patients but provides no evidence to back up this claim. In fact, surveys have indicated that many long Covid patients experience PEM—not just a “small set” of them."

https://www.virology.ws/2022/04/08/trial-by-error-more-on-the-regain-trial-for-long-covid-patients/

 

To paraphrase, the researchers are saying little is known about LC, but there are no "Serious Adverse Events" expected by putting study subjects through GET and CBT.

This seems to violate the precautionary principle, which those in emergency settings use: make sure it's safe before you proceed.

The researchers appear to be confident that no harm will come to the participants, even though knowledge about this disease is in its infancy.

Again, circular explanations: no harm will come to you, because I say no harm will come to you.

Already dismissing LC as psychological?

What about neurological and cardiological findings that show evidence of physical problems? What about PEM?

Here we go again.

 

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

 

"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."