200 million, now that's proper budget with which you can do a tremendous amount of exercise and lifestyle intervention studies.
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USA: The RECOVER Initiative - Long Covid research
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200 million, now that's proper budget with which you can do a tremendous amount of exercise and lifestyle intervention studies.
Mij
Senior Member (Voting Rights)
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rvallee
Senior Member (Voting Rights)
Infection-associated chronic conditions, such as Long COVID, have been notoriously difficult to solve. Despite years of research, the underlying biological mechanisms for conditions such as myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), Post-Treatment Lyme Disease Syndrome and a host of other infection-associated chronic conditions have not been identified, and many symptoms of these conditions remain difficult to treat. However, unlike some infection-associated chronic conditions for which the source of infection is unknown, we know that Long COVID is caused by the SARS-CoV-2 virus, which may prove advantageous in research.
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These studies, and others will provide important insights into Long COVID and will improve our understanding of other infection-associated chronic conditions with similar symptoms to inform treatments.
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These studies, and others will provide important insights into Long COVID and will improve our understanding of other infection-associated chronic conditions with similar symptoms to inform treatments.
The announcement is signed by the new NIH director, Monica M. Bertagnolli.
The years of research-trope always feels like a kick in the nards when it comes from influential people/organizations. Whilst technically true I doubt 3 guys and their lab robot processing blood results for 20 years would constitute years of research for any other line of inquiry.
And yes I know I'm selling a lot of people short here, I just wish those people would get funded properly so we can get out of this hellhole in due time.
That should be enough funding to now not only run their highly promising study on Red Light Therapy, but even Green Light Therapy and possibly even the whole colour pallet.
On a more serious note: I desperately hope the money will be spent on promising research looking at pathomechanisms and not majorly wasted again as this could be the last round of funds if the research leads nowhere.
On a more serious note: I desperately hope the money will be spent on promising research looking at pathomechanisms and not majorly wasted again as this could be the last round of funds if the research leads nowhere.
Kalliope
Senior Member (Voting Rights)
Sorry if this is the wrong thread. Thought this seemed like a good general article on Long Covid and then came this:
Medscape: Virus and Booster Apathy Could Be Fueling Long COVID
"There still isn't a great way to treat any of this," said Risbano, whose clinic is involved with the National Institute of Health's RECOVER-VITAL trial, which is evaluating potential treatments including Paxlovid and exercise to treat autonomic dysfunction with similarities to myalgic encephalomyelitis/chronic fatigue syndromeand POTS, exercise intolerance, and neurocognitive effects such as brain fog.
Risbano and colleagues have found that physical therapy and exercise training have helped patients with exercise intolerance and neurocognitive problems. "It's not a quick thing where they go through one visit and are better the next day," he stressed. "It takes a little bit of time, a little bit of effort, a little bit of homework — there are no silver bullets, no magic medications."
Medscape: Virus and Booster Apathy Could Be Fueling Long COVID
"There still isn't a great way to treat any of this," said Risbano, whose clinic is involved with the National Institute of Health's RECOVER-VITAL trial, which is evaluating potential treatments including Paxlovid and exercise to treat autonomic dysfunction with similarities to myalgic encephalomyelitis/chronic fatigue syndromeand POTS, exercise intolerance, and neurocognitive effects such as brain fog.
Risbano and colleagues have found that physical therapy and exercise training have helped patients with exercise intolerance and neurocognitive problems. "It's not a quick thing where they go through one visit and are better the next day," he stressed. "It takes a little bit of time, a little bit of effort, a little bit of homework — there are no silver bullets, no magic medications."
Mij
Senior Member (Voting Rights)
https://trials.recovercovid.org/autonomic
NIH opens long Covid trials to evaluate treatments for autonomic nervous system dysfunction
Part of NIH’s RECOVER Initiative, trials will test at least three treatments for symptoms such as fast heart rate, dizziness and fatigue.
https://www.nih.gov/news-events/new...eatments-autonomic-nervous-system-dysfunction
NIH opens long Covid trials to evaluate treatments for autonomic nervous system dysfunction
Part of NIH’s RECOVER Initiative, trials will test at least three treatments for symptoms such as fast heart rate, dizziness and fatigue.
https://www.nih.gov/news-events/new...eatments-autonomic-nervous-system-dysfunction
From X
Can we clone Todd Davenport ?
I spoke with members of the NIH RECOVER oversight committee in a meeting that was going to include the RECOVER-ENERGIZE PI before it didn't. My input was to include pacing in an adaptive design to ensure participants could move in and out of exercise groups if they crashed.
Instead, what we got was the UK PACE trial without the CBT arm. In other words, repeating the same mistakes at scale that we've already made with ME/CFS. Pacing is a core competency of attempting to live with PEM, not a separate intervention to be compared to others.
The current conceptualization of RECOVER-ENERGIZE fails to reflect the reality of PEM and how strategies to balance activity with rest are used to manage PEM. So, not only is the trial unrealistic, it's unlikely to balance risks and harms to participants. It shouldn't pass IRB.
I provided the feedback that the RECOVER projects are artificially siloed because each project focuses on a small piece of the same phenomenon--PEM. From the top of the project on down, it is clear there are smart, well-meaning people working on this who don't understand PEM.
This is best encapsulated by the remarks of the RECOVER-ENERGIZE PI on a recent podcast, which suggest he is thinking about PEM as his research background and training would suggest in heart failure. PEM is a lot of things, and some of those things look like heart failure. But...
...PEM pathophysiologically isn't really like heart failure, doesn't behave clinically like heart failure in a substantial way, and doesn't respond to heart failure similarly to heart failure. Critically, exercise responses in people with heart failure and PEM are different.
But, we're going to get a heart failure intervention trial for PEM. I just wish someone along the way would have listened to lived experience or prior scientific endeavors to understand PEM before proceeding forward with decisions that apparently have been difficult to un-make.
I don’t know. Maybe I am completely naïve, but finding someone who understands the disease that’s the subject of a study to lead that study doesn’t seem beyond the realm of reasonableness to me.
I have no illusions I’ve got the kind of entitlement where I just clap my hands and everything I say suddenly happens, but let’s just say as an exercise scientist and physical therapist who has studied PEM for 15 years, this is not at all what I would do nor advocated to be done.
Can we clone Todd Davenport ?
I spoke with members of the NIH RECOVER oversight committee in a meeting that was going to include the RECOVER-ENERGIZE PI before it didn't. My input was to include pacing in an adaptive design to ensure participants could move in and out of exercise groups if they crashed.
Instead, what we got was the UK PACE trial without the CBT arm. In other words, repeating the same mistakes at scale that we've already made with ME/CFS. Pacing is a core competency of attempting to live with PEM, not a separate intervention to be compared to others.
The current conceptualization of RECOVER-ENERGIZE fails to reflect the reality of PEM and how strategies to balance activity with rest are used to manage PEM. So, not only is the trial unrealistic, it's unlikely to balance risks and harms to participants. It shouldn't pass IRB.
I provided the feedback that the RECOVER projects are artificially siloed because each project focuses on a small piece of the same phenomenon--PEM. From the top of the project on down, it is clear there are smart, well-meaning people working on this who don't understand PEM.
This is best encapsulated by the remarks of the RECOVER-ENERGIZE PI on a recent podcast, which suggest he is thinking about PEM as his research background and training would suggest in heart failure. PEM is a lot of things, and some of those things look like heart failure. But...
...PEM pathophysiologically isn't really like heart failure, doesn't behave clinically like heart failure in a substantial way, and doesn't respond to heart failure similarly to heart failure. Critically, exercise responses in people with heart failure and PEM are different.
But, we're going to get a heart failure intervention trial for PEM. I just wish someone along the way would have listened to lived experience or prior scientific endeavors to understand PEM before proceeding forward with decisions that apparently have been difficult to un-make.
I don’t know. Maybe I am completely naïve, but finding someone who understands the disease that’s the subject of a study to lead that study doesn’t seem beyond the realm of reasonableness to me.
I have no illusions I’ve got the kind of entitlement where I just clap my hands and everything I say suddenly happens, but let’s just say as an exercise scientist and physical therapist who has studied PEM for 15 years, this is not at all what I would do nor advocated to be done.
Please read this thread:
https://twitter.com/user/status/1788017390162153971
https://twitter.com/user/status/1787963100328591613
I’m going to summarize the interview with Dr. Adrian Hernandez, at Duke, who is coordinating RECOVER’s trials. Dr. Hernandez’s comments are disappointing, and I think shed light on what went wrong with RECOVER
I’ve tried so hard with this account to keep it very level-headed with researchers, but I can’t hold my tongue about what happened with RECOVER. Nobody at the NIH, Duke, NYU, or RTI leading this $1.15bn effort is qualified, and this “collegiality” may cost me a lot of my life
And then this Yamey guy muted the thread.
https://twitter.com/user/status/1788017390162153971
https://twitter.com/user/status/1787963100328591613
I’m going to summarize the interview with Dr. Adrian Hernandez, at Duke, who is coordinating RECOVER’s trials. Dr. Hernandez’s comments are disappointing, and I think shed light on what went wrong with RECOVER
I’ve tried so hard with this account to keep it very level-headed with researchers, but I can’t hold my tongue about what happened with RECOVER. Nobody at the NIH, Duke, NYU, or RTI leading this $1.15bn effort is qualified, and this “collegiality” may cost me a lot of my life
And then this Yamey guy muted the thread.
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Kalliope
Senior Member (Voting Rights)
NIH News Releases:
NIH to open long COVID clinical trials to study sleep disturbances, exercise intolerance, and post exertional malaise
quote:
RECOVER-SLEEP clinical trials will soon begin enrolling participants and include:
NIH to open long COVID clinical trials to study sleep disturbances, exercise intolerance, and post exertional malaise
quote:
RECOVER-SLEEP clinical trials will soon begin enrolling participants and include:
- A trial to test two drugs (modafinil and solriamfetol) approved by the Food and Drug Administration to treat people who have problems staying awake during the day, known as hypersomnia. These medications are well-known but have not been studied widely in people with long COVID. Participants will be randomly assigned to receive either the active study drug or a placebo control for eight to 10 weeks, depending on the assigned study drug.
- A trial to test potential treatments for complex sleep disturbances due to long COVID, including melatonin, an over-the-counter supplement commonly used to treat people with sleep disorders and general insomnia; and light therapy, which is used to help people reset their sleep cycles. Participants will be randomly assigned to receive either melatonin or a placebo control, and either high-intensity (active) light therapy or low-intensity (placebo) light therapy for eight weeks.
- A trial to test a program that combines exercise training, strength and flexibility training, education, and social support, collectively known as personalized cardiopulmonary rehabilitation. The program is designed to help people who experience exercise intolerance with symptoms such as shortness of breath and fatigue during exercise after having COVID-19. All participants in RECOVER-ENERGIZE trials will be screened for PEM. Participants who are identified as having PEM, via a validated PEM questionnaire, will not be included in this trial. Participants will be randomly assigned to receive either personalized cardiopulmonary rehabilitation or basic exercise education for three months.
- A trial to test a program known as structured pacing, which is designed to help participants with PEM identify, control, and minimize symptoms that developed after having COVID-19 by regulating or pacing their daily activities. Currently, structured pacing is the only intervention used to treat PEM. The trial will not include any exercise training or physical movement to protect participants from developing worsened symptoms of PEM. Participants will be randomly assigned to receive either structured pacing with a trained coach or basic PEM education for three months.
Physical activity being tracked by Fitbit……..
rvallee
Senior Member (Voting Rights)
One thing that hasn't been addressed is frankly: why? What exactly is expected that this trial will inform, when there have been hundreds such trials already? Done on a large number of variations and conditions overlapping with Long Covid, out of which exactly nothing has been learned.
Because that last part is crucial. What exactly can it be said has been learned from those hundreds of trials? Absolutely nothing, they are not research. Pragmatic trials are not research, they are merely trying something and see how it goes.
So what will this umpteenth trial, larger but still largely on the same model, inform where hundreds of similar trials have failed so far to produce a single useful bit of evidence?
I've never seen anyone even bothering to answer this. It's merely asserted that something useful could come out of it, but it ignores the fact that this has been tried again and again and again before, and it has produced NOTHING.
Insanity.
Because that last part is crucial. What exactly can it be said has been learned from those hundreds of trials? Absolutely nothing, they are not research. Pragmatic trials are not research, they are merely trying something and see how it goes.
So what will this umpteenth trial, larger but still largely on the same model, inform where hundreds of similar trials have failed so far to produce a single useful bit of evidence?
I've never seen anyone even bothering to answer this. It's merely asserted that something useful could come out of it, but it ignores the fact that this has been tried again and again and again before, and it has produced NOTHING.
Insanity.
These are the 4 trials:
* stimulants to make people experiencing hypersomnia stay awake
* melatonin and light exposure to reset sleep cycles
* 'personalised cardiopulmonary rehabilitation' - exercise, education and social support (supposedly not for people with PEM)
* 'structured pacing' for people with PEM (either with a trained coach or 'basic PEM education for three months')
Some potential to harm, some small potential to help. My bet is that nothing much will help, but that some of this will be presented as being useful so clinicians can feel happy that there is something to offer.
* stimulants to make people experiencing hypersomnia stay awake
* melatonin and light exposure to reset sleep cycles
* 'personalised cardiopulmonary rehabilitation' - exercise, education and social support (supposedly not for people with PEM)
* 'structured pacing' for people with PEM (either with a trained coach or 'basic PEM education for three months')
Some potential to harm, some small potential to help. My bet is that nothing much will help, but that some of this will be presented as being useful so clinicians can feel happy that there is something to offer.
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Thanks for the analysis - I was hoping they'd - monitor sleep and if e.g. sleep was disrupted then look at other illnesses, with similarly disrupted sleep, and ask - how much of the symptoms are common i.e. related to sleep disturbance. Yes if "X" works in a known/understood illness (with a similar symptom) then try "X" in a controlled manner.These are the 4 trials:
* stimulants to make people experiencing hypersomnia stay awake
* melatonin and light exposure to reset sleep cycles
* 'personalised cardiopulmonary rehabilitation' - exercise, education and social support (supposedly not for people with PEM)
* 'structured pacing' for people with PEM (either with a trained coach or 'basic PEM education for three months')
Some potential to harm, some small potential to help. My bet is that nothing much will help, but that some of this will be presented as being useful so clinicians can feel happy that there is something to offer.
My initial reaction to their proposals is that they don't seem to be what's required - what's new - why don't they consult on proposed research!
They say they did. And Lucinda Bateman seems to be involved in, at least, the 'structured pacing' trial.
I'm not sure what 'structured pacing' is, but I doubt that it's the only intervention used to prevent post-exertional malaise. Still, I guess it's ok to find out how best to teach newly diagnosed people about PEM and activity management. I think the best way to reduce PEM is to support the person, financially so they can reduce work hours, and practically, so they can still live well while doing less. But I expect that's not what 'structured pacing' is all about.
Slide 19 of the presentation posted here: https://www.s4me.info/threads/usa-t...-long-covid-research.30525/page-7#post-531223
suggests it's a fairly energy-intensive process in itself - "Task analysis to identify and prioritize illness-impacted tasks and functions" and "Activity analysis to create strategies for getting must-do tasks done without causing PEM" etc - there's a pretty narrow Venn diagram overlap of "ill enough to benefit from this" and "well enough to do it".
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I reckon they should just do a large sleep study i.e. using high end actimetry - then look at possible interventions and run trials on groups who have an identified problem + existing treatment already approved. See what comes out of it!
Yes, there should be support systems (social security benefits etc.) - certainly I don't consider they're adequate in the UK!