Yes, but I would amend that to global rather than particularly in the UK. The UK is most visible to us, and its where a lot of the research is done, but uncritical acceptance appears global to me. Its only now after multiple independent reviews and multiple failures to get any objective evidence that things are changing.
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Protocol ReCOVer: A RCT testing the efficacy of CBT for preventing chronic post-infectious fatigue among patients diagnosed with COVID-19.
- Thread starter Grigor
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Esther12
Senior Member (Voting Rights)
At the same time, asking participants to wear actometers for at least six months (you need at least two time points) is much more of a burden. I wonder if they'll look at whether activity stayed constant over the 12 days, or changed over that time.
of course they could always discount those results afterwards as not objective after all because of economic changes. but still best to not include them at all.
A lot of people wear a Fitbit or equivalent 365 days a year
Snow Leopard
Senior Member (Voting Rights)
Or they could hold on to the data for many years until they have enough data from multiple studies to perform a meta-analysis and then conclude that hours worked is not associated with recovery of "severe post-infectious fatigue following COVID-19" therefore it should never be used as an outcome measure for an upcoming "final, kind of, definitive trial".
(I apologize to anyone who doesn't know the various references I am hinting at)
Keela Too
Senior Member (Voting Rights)
Totally agree with a longer time period. Though I think even a month is rather too short.
I remember early in my illness trying to “gradually increase” my level of activity and crashing every 6 weeks to a lower level (which after the crash caused a long-term ratcheting downwards of my health after each period of apparent “improvement”!).
Of course each time I thought I could return to where I had been prior to the crash, which set me up for creating the next one. Accepting how little I could do (even if feeling okay at the time) without harming my future health was incredibly tough!
Thankfully I have more flexibility now, but I am always alert to tell-tale signs!
So I’d err on the 3 month side, and if the trend was still changing (up or down), that the measurements should continue. (A bit like measuring the dry weight of something, when you keep on with the drying and measuring process til you get a consistent weight.)
No more so than wearing a t-shirt or a digital watch. Fitbits, for example, weigh less than 30g (≈1oz), and are designed to be as unobtrusive as possible.
I've worn a fitbit instead of a watch for several years now. It tells me the time, my current heart rate usually reasonably accurately and how many steps or equivalent I've done. Apart from needing to remember to charge it about once a week, it's no more trouble than wearing a watch.
I think any study monitoring activity for pwME, pwLC etc, needs to run for at least 3 months and have a 3 month long follow up a year later, wearing the actimeter throughout the 3 months each time. Or better still, run it for a year.
I think any study monitoring activity for pwME, pwLC etc, needs to run for at least 3 months and have a 3 month long follow up a year later, wearing the actimeter throughout the 3 months each time. Or better still, run it for a year.
rvallee
Senior Member (Voting Rights)
I haven't read in-depth but am curious about how candid they will be about it to the patients, seeing how they define it here. The level of candor from these people is basically "snitch in prison trying to worm out of a bad situation".
Then again PACE did the same, explicitly had the illness beliefs woo in its official documents but presented it otherwise to the patients, who wouldn't know any better unless they read the manual (or listened to the sub-text but whatever).
rvallee
Senior Member (Voting Rights)
Lots of pwME wear them all the time and have for years. It would be a selective factor for people who can't tolerate them but they're common enough that it doesn't make much sense to get blocked by this.
Especially when the "treatment" is an exercise program.
Esther12
Senior Member (Voting Rights)
I don't wear a watch because it's too much trouble - I might be unusually lazy.
hibiscuswahine
Senior Member (Voting Rights)
Yes, the actigraph adds bias, and suggests they don’t trust the clients activity diary, and want an “objective measure”.
Usual priming the patient for their CBT outcomes. How to be a good patient for the therapist.
Cognitive behavioural variables, that’s a new one. BPS variables. Transdiagnostic got mentioned, part of the PPS model developed by Chalder
this was an odd one as a final realised goal
They wanted people initially to stop napping and spread their activities out but then they had to quit that. How confusing for the patient!
A regular sleep wake pattern is good and should be encouraged for all people. It is so often not achievable in ME/CFS and if interrupted by various factors often causes flares and relapses. Not that they would care.
Usual priming the patient for their CBT outcomes. How to be a good patient for the therapist.
Cognitive behavioural variables, that’s a new one. BPS variables. Transdiagnostic got mentioned, part of the PPS model developed by Chalder
this was an odd one as a final realised goal
They wanted people initially to stop napping and spread their activities out but then they had to quit that. How confusing for the patient!
A regular sleep wake pattern is good and should be encouraged for all people. It is so often not achievable in ME/CFS and if interrupted by various factors often causes flares and relapses. Not that they would care.
I want to know how many years you have to do this to see results? Yes, I mean years. Then how do you deal with the extremely dangerous side effects? I did this for well over two years, and had to deal with regularly passing out from my OI, sometimes three times in five minutes, on stairs. In my case sleep hygiene leads to sleep deprivation which leads to worsening of orthostatic intolerance, and that is before we get to microsleeps and waking dreams.
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Arvo
Senior Member (Voting Rights)
Here's the recruitment page: Moe na COVID-19? | Doe mee aan de ReCOVer studie
They outright state: "We already know that chronic fatigue can succesfully be treated with cognitive behaviour therapy."
To continue: "We wonder if cognitive behaviour therapy can also help prevent that fatigue after COVID-19 becomes chronic."
("We weten al dat chronische vermoeidheid succesvol kan worden behandeld met cognitieve gedragstherapie. We vragen ons af of cognitieve gedragstherapie ook kan helpen voorkomen dat vermoeidheid na COVID-19 chronisch wordt.")
In the opening part of the text it is emphasised twice that the study will be about seeing if CBT prevents chronic fatigue.
It also says that participants from the control group who are still fatigued after the trial will still* be offered "Fit after COVID".
*It doesn't translate well, but the word "alsnog" in Dutch implies that they have missed out the first time, like something is corrected which should have happened in the first round.
(Deelnemers uit de controlegroep die na afronding van het onderzoek nog steeds moe zijn, krijgen alsnog “Fit na COVID” aangeboden.)
This doesn't only influence the control group in how they would subjectively assess their condition in the trial (because it is set against a we-know-this-works treatment the other group is getting, which they know will be offered to them too after they are done), but it also prevents long term follow up comparison between the groups.
I don't know if it's usual, but the study aim is also emphasised (again) explicitly: "The hope is that patients are less tired after "Fit after COVID" and the fatigue complaints do not get chronic"
(De hoop is dat patiënten minder moe zijn na “Fit na COVID” en de vermoeidheidsklachten niet chronisch worden.) So both treatment arms will have this expectation of the treatment when they apply.
Also application was for patients who were fatigued between 3-12 months, a lot of time to recover naturally anyway (as lots of Long COVID patients have thankfully been doing in the first 18 months). This fact alone will give no doubt about this trial being called "succesful", because it's a sure thing that there will be improvement in treatment arm patients.
And then there's the prominent logo's and mention of five participating hospitals. Combined with the rest it seems used to instill a sense of authority/effectiveness.
They at least didn't at the recruitment page. The trial was full on 27-8-2021, and they started recruiting at least since February, so I'm guessing they are well on their way.
edited: small bit of clarifying text added
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Keela Too
Senior Member (Voting Rights)
Adds bias?
I would have thought activity diaries would be much more biased no matter how carefully completed.
I know I couldn’t find a suitable way of subjectively measuring my activity, and that despite their quirks, I found that a step-counter was MUCH more useful to me in estimating my daily exertion levels.
Edit to add: I’m aware that a patient might alter their behaviour “knowing” they are wearing a measuring device, but I think that alteration is surely much less than the subjective alterations, of “I think I’m doing better, so I’ll report that I definitely am doing better” type of measure.
Peter T
Senior Member (Voting Rights)
Indeed I would have thought keeping an activity diary could be as likely or even more likely to cause changes in behaviour than a worn measuring device. Over time it is possible to forget you are wearing a device, but keeping a diary is by necessity always a conscious act.
hibiscuswahine
Senior Member (Voting Rights)
To the questions above @Peter, @Keela Too
Any recorded activity or new intervention, not normally done by the patient adds bias, people are motivated to do this activity to fill it in for a person they perceive to be in authority eg. therapist, to be a good study participant.
Similarly with wearing an actigraph (embedded in an iWatch and presumably a Fitbit). When you have to actively put this on, after showering, wear it an bed etc it is a conscious action.
I personally don’t use tech or diaries, I work out how I am feeling by listening to my body and making my own judgement on my physical state of health and what measures I should be doing to improve things based on past experience.
@alex3619 You appear not to agree with my statement and want answers that I am unable to give. I have significant sleep problems to do with circadian rhythm and myalgia/arthralgia and just run with them. Currently I am constant state of PEM, no matter what I do and will take months, maybe even years to recover. People all have different trajectories and comorbidities to their illness, some have more sleep problems than others. We all appear to do a variety of stop, rest, pace and when I am in relapse it is stop, go to bed, rest, may sleep. Maybe I am alone in trying to keep to a regular “big sleep overnight” (even with multiple wakings) and rise about the same time very early in the morning….Usually this gradually eases off, may be due to better pacing but some times quite idiosyncratic and I start to wake later and often my PEM is less severe and I know I am in recovery from the depths of this relapse/loss of functioning. Clearly we have different manifestations of the illness. I also choose to take a very low dose of sleeping medication which has helped considerably.
Any recorded activity or new intervention, not normally done by the patient adds bias, people are motivated to do this activity to fill it in for a person they perceive to be in authority eg. therapist, to be a good study participant.
Similarly with wearing an actigraph (embedded in an iWatch and presumably a Fitbit). When you have to actively put this on, after showering, wear it an bed etc it is a conscious action.
I personally don’t use tech or diaries, I work out how I am feeling by listening to my body and making my own judgement on my physical state of health and what measures I should be doing to improve things based on past experience.
@alex3619 You appear not to agree with my statement and want answers that I am unable to give. I have significant sleep problems to do with circadian rhythm and myalgia/arthralgia and just run with them. Currently I am constant state of PEM, no matter what I do and will take months, maybe even years to recover. People all have different trajectories and comorbidities to their illness, some have more sleep problems than others. We all appear to do a variety of stop, rest, pace and when I am in relapse it is stop, go to bed, rest, may sleep. Maybe I am alone in trying to keep to a regular “big sleep overnight” (even with multiple wakings) and rise about the same time very early in the morning….Usually this gradually eases off, may be due to better pacing but some times quite idiosyncratic and I start to wake later and often my PEM is less severe and I know I am in recovery from the depths of this relapse/loss of functioning. Clearly we have different manifestations of the illness. I also choose to take a very low dose of sleeping medication which has helped considerably.
I have no problem with this. I was not questioning you specifically, but the whole notion of sleep hygiene. Over time I have seen some patients get worse and worse sleep. I am one of them. Under three years sick its not too bad. Over 10 years or so it can get quite bad. Every decade or so sees a worsening of my sleep. Once I hit non 24 I thought it was as bad as it could go. I was wrong. There are at least two stages after that, both of which I experience.
If the problem is sleep entrainment I expect that non 24 is as bad as it will go.
If the problem is loss of sleep entrainment in sighted people then sleep hygiene can be great. If the problem is actual dysfunction of the brain due to other reasons it might help a bit but will probably fail.
As a side note, something I speculate about, salicylate sensitivity can manifest as a sleep disorder due to a negative effect on PGD2 synthesis in the brain, and this is required for sleep. Sleep is an active process, not passive, and if that process is impeded then sleep will be degraded.
Sleep chemistry also requires that different parts of the brain coordinate with each other. I suspect that is happening much less in many with ME due to an old Komarof study.
Because of breathing related disorders I do not take sleeping pills. I actually need to be able to wake up instantly if there is a problem. This makes things more difficult.
In any case I know someone who takes a whole lot of different sleep meds, but each one only for a few nights so there is not time to develop tolerance. Then they move to the next med, and continue in a cycle of changing meds. This approach may or may not be useful to some people.
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That was me for a while in the 90s. Rest, time, attention to muscle stress, and pacing were the only things that helped, and it was not a rapid improvement. Indeed it took me about 20 years with extreme muscle pain (less extreme in the last 5 years) before it mostly went away. Its still there though, the pain will flare up if I overdo things.
One of the things that made the muscle pain worse for me, aside from working at a job that aggravated it, was physio exercises. The most extreme issue was static muscle load. Whenever a muscle had to hold a position for a while that muscle started hurting. Any use of that muscle after that made it worse.
Patient experiences are different especially over time. Its not the same illness for many of us at 30 years as it was at 20 or 10. However, based on very limited anecdotal evidence, in some ways patient symptoms might slowly become more similar after a few decades. This is speculative and I would love very long term patients to comment on this.
Keeping a diary definitely impacts behavior. this is well-known in studies of diet, when people keep a food diary for 3 days or a week. No one wants to write down chocolate bars and donuts and supersize glasses of Coke. So they tend to forget to write them down, or simply avoid those foods during the process--not even necessarily on purpose. It's just the nature of observing and recording your own behavior.