Activity monitoring and patient-reported outcome measures in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome patients, 2022, Rekeland et al

[SNT Gatchaman]

Activity monitoring and patient-reported outcome measures in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome patients
Rekeland IG, Sørland K, Bruland O, Risa K, Alme K, Dahl O, Tronstad KJ, Mella O, Fluge Ø

Introduction: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a disease with no validated specific and sensitive biomarker, and no standard approved treatment. In this observational study with no intervention, participants used a Fitbit activity tracker. The aims were to explore natural symptom variation, feasibility of continuous activity monitoring, and to compare activity data with patient reported outcome measures (PROMs).

Materials and methods: In this pilot study, 27 patients with mild to severe ME/CFS, of mean age 42.3 years, used the Fitbit Charge 3 continuously for six months. Patients wore a SenseWear activity bracelet for 7 days at baseline, at 3 and 6 months. At baseline and follow-up they completed the Short Form 36 Health Survey (SF-36) and the DePaul Symptom Questionnaire-Short Form (DSQ-SF).

Results: The mean number of steps per day decreased with increasing ME/CFS severity; mild 5566, moderate 4991 and severe 1998. The day-by-day variation was mean 47% (range 25%-79%). Mean steps per day increased from the first to the second three-month period, 4341 vs 4781 steps, p = 0.022. The maximum differences in outcome measures between 4-week periods (highest vs lowest), were more evident in a group of eight patients with milder disease (baseline SF-36 PF > 50 or DSQ-SF < 55) as compared to 19 patients with higher symptom burden (SF-36 PF < 50 and DSQ-SF > 55), for SF-36 PF raw scores: 16.9 vs 3.4 points, and for steps per day: 958 versus 479 steps. The correlations between steps per day and self-reported SF-36 Physical function, SF-36 Social function, and DSQ-SF were significant. Fitbit recorded significantly higher number of steps than SenseWear. Resting heart rates were stable during six months.

Conclusion: Continuous activity registration with Fitbit Charge 3 trackers is feasible and useful in studies with ME/CFS patients to monitor steps and resting heart rate, in addition to self-reported outcome measures.

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[Trish]

This looks like a useful study, and I hope will encourage clinical trial researchers to include continuous activity monitoring throughout their trials.

 

[Sid]

mild 5566, moderate 4991 and severe 1998

That's a lot of steps, especially for severe patients. When I was severe I was doing less than 500 steps per day.

Fitbit recorded significantly higher number of steps than SenseWear.

Not surprised to see this. I've long suspected that Fitbit is inaccurate and tracks arm movements.

Good study, useful results.

 

[Trish]

I don't think it matters that a wrist worn Fitbit measures significant arm movements as well as steps. For me at least, I find things like dressing, or trying to hold my body upright while being pushed along bumpy ground in a wheelchair, are physically just as draining as my small steps shuffling around the house. It's all physical activity.

So long as a study looks at each individual's change over time, rather than just averaging everyone, it should pick up patterns of improvement, worsening or fluctuation.

 

[NelliePledge]

Yeah I record more on days when I’m doing (clothes) washing

and yeah those numbers seem high I’m moderate and on bad days less than 1000 steps

 

[rvallee]

One thing I would like to know is what number of daily steps would our BPS overlords deem appropriate to dismiss severe deconditioning, the kind they always refer to as being bedbound for an extended period, as a reason for symptoms? Not high performance, enough to cause the serious symptoms since a significant % of the population out there lives perfectly healthy but sedentary lives, not being any more active than this but suffering no notable illness, nothing they would consider amounting to illness.

Since the average is somewhere in the 5K-10K and most patients are close to that, how can they maintain their claims that this is the result of severe inactivity, when 5K is more than plenty enough to dismiss this? When likely well over a billion people out there live similarly low activity lives without the heavy burden of chronic illness.

Not that I'd expect this admission to embarrass anyone, cognitive dissonance is a requisite for this ideology, but I'm disgusted by the ongoing lying about things that have been debunked long ago.

Because this flies in the face of GET. Which was always silly, but GET is a veritable obsession and a necessary factor for the ideology. And yet it's a complete fabrication, verifiably false. And this is in addition to the number of pwLC who were at peak physical conditions mere days before their illness began.

If the truth is irrelevant in medicine, I have no idea how this is all even supposed to work. We're supposed to deal with facts here, and instead we're oppressed based entirely on feelings built on lies. And that's just wrong, plain and straight wrong.

 

[Jonathan Edwards]

Good to see this has been accomplished. It would be nice to see some detailed analysis of activity patterns.

 

[DokaGirl]

Yeah I record more on days when I’m doing (clothes) washing

and yeah those numbers seem high I’m moderate and on bad days less than 1000 steps

Yes, the numbers seem too high.

 

[DokaGirl]

One thing I would like to know is what number of daily steps would our BPS overlords deem appropriate to dismiss severe deconditioning, the kind they always refer to as being bedbound for an extended period, as a reason for symptoms? Not high performance, enough to cause the serious symptoms since a significant % of the population out there lives perfectly healthy but sedentary lives, not being any more active than this but suffering no notable illness, nothing they would consider amounting to illness.

Since the average is somewhere in the 5K-10K and most patients are close to that, how can they maintain their claims that this is the result of severe inactivity, when 5K is more than plenty enough to dismiss this? When likely well over a billion people out there live similarly low activity lives without the heavy burden of chronic illness.

Not that I'd expect this admission to embarrass anyone, cognitive dissonance is a requisite for this ideology, but I'm disgusted by the ongoing lying about things that have been debunked long ago.

Because this flies in the face of GET. Which was always silly, but GET is a veritable obsession and a necessary factor for the ideology. And yet it's a complete fabrication, verifiably false. And this is in addition to the number of pwLC who were at peak physical conditions mere days before their illness began.

If the truth is irrelevant in medicine, I have no idea how this is all even supposed to work. We're supposed to deal with facts here, and instead we're oppressed based entirely on feelings built on lies. And that's just wrong, plain and straight wrong.

Excellent point about the average person out there may do pretty much the same amount of steps as pwME, or somewhat more, but not extraordinarily more.

And, as you say, how can this similar amount of steps for pwME be called deconditioning, when the average person out there is not blamed for being deconditioned?

 

[BrightCandle]

Yes, the numbers seem too high.

Way too high. When I was severe even with it counting my arm movements I rarely got above 100.

 

[Michelle]

It would be interesting to see how step counts correlate with, say, the Karnofsky scale (the only questionnaire Solve ME/CFS Initiative is using that seems at all relevant to my daily life) as that asks questions related to other types of activity (how long can you be out of bed, etc.). At the moment my step counts are now between 500-700 a day compared to 350 a year ago, but I'm actually able to spend several hours a day out of bed compared to only an hour a year ago--something that feels like a huge change in quality of life that isn't reflected in my step counts. I also use "metrics" like can I sit up in bed and do embroidery or crochet? How much can I read? Cook?

While I generally only use a pedometer clipped to my underwear, I have played around with a knock-off FitBit in addition to the pedometer. My memory is that when my pedometer was showing 350 or so steps/day, the FitBit was showing 900 or so steps (and like a lot of people, their "severe" numbers seem awfully high to me, even with the problem around wrist measurements). But I agree with @Trish that the important thing is a consistent metric.

 

[Keela Too]

The point about the “maximum difference” is interesting. I’m assuming that means how much more the high activity days are than the average days.

When I was severe (in my case around 500 steps a day) I had VERY little flexibility. 600 steps was almost impossible due to the disproportionately greater PEM.

Now that I’m doing so much better (current annual average step count around 4500) I find I also have vastly greater flexibility. I did 8000 steps today, and although that’s not something I could repeat every day, it is now feasible without serious consequences.

I’d love to know what has changed, that I can now have so much greater freedom. Yet still be ill enough that I can’t get fitter through my own efforts, nor push through if my body just says NO!

 

[SNT Gatchaman]

Out of interest I collated my steps, distance, walk speed/stability graphs. These are captured in the background by iPhone/Apple Watch. For reference, I started to become sick in Dec 20/Jan 21, carried on for 6 months but fell off the perch in late Jun 21. I have cycling graphs which showed a stable 21 km daily average for years that stopped dead at that time.

I don't think the paper's categorisation of 2000 steps/day as severe is realistic (or one of us has got an odd idea of what severe is). Interesting to compare with @Keela Too in the comment above. I'm barely over 500 steps and 500m per day, but I would consider myself at the mild end of moderate: able to continue a sedentary but intellectually demanding job half-time, 5 days/week for nearly all of this year.

The last graphs show the reduction in walking speed and stability: "the long COVID shuffle".

 

[Hutan]

Interesting, @SNTGatchman

"Walking asymmetry:
Walking asymmetry is the percent of time that a user's steps with one foot are faster or slower than the other foot. The system automatically records walking asymmetry samples on iPhone 8 or later. The user must carry their phone near their waist—such as in a pocket—and walk steadily on flat ground.

What is a good walking asymmetry percentage iPhone?
The average walking asymmetry for healthy, younger adults falls between 5 and 15 percent, while older adults are typically closer to 15 to 20 percent, according to a study in the journal Medicine & Science in Sports & Exercise"

Your post-ME/CFS/LC walking asymmetry data looks like how I feel about my walking. On some days, I have the gait, the power and the clumsiness of an elderly person, on other days, it's totally fine. SNTGatch, if you feel inclined to share, what were you doing in July 2022? I wonder if this would be a way to assess PEM, or changes in severity over time.

(If you'd rather I deleted this post or the last question, just let me know.)

 

[Sean]

The correlations between steps per day and self-reported SF-36 Physical function, SF-36 Social function, and DSQ-SF were significant.​

Interesting contrast to Wiborg's finding of no correlation between self-report fatigue and actimeter/actigraph results (for CBT intervention).

"Although CBT effectively reduced fatigue, it did not change the level of physical activity. Furthermore, changes in physical activity were not related to changes in fatigue."​

So, without that cognition modifying intervention patients are accurately reporting activity levels. With that cognition modifying intervention they are not.

Seems like evidence against the presumption of distorted cognition in patients, and for CBT actively distorting cognition in patients.

 

[SNT Gatchaman]

Your post-ME/CFS/LC walking asymmetry data looks like how I feel about my walking. On some days, I have the gait, the power and the clumsiness of an elderly person, on other days, it's totally fine. SNTGatch, if you feel inclined to share, what were you doing in July 2022? I wonder if this would be a way to assess PEM, or changes in severity over time.

Yes that was quite a surprise to see that sharp a change. I had been doing reasonably well over this year. Eg there are many days when I can walk around the house as normal, stand up from the couch almost as normal, but more recently days where I have to give myself a boost with arms, much as you would see in the elderly. It really feels as though my thigh muscles are hugely depowered, along with the rest. However that can be back to baseline even within a day, or certainly a week. Whether this is PEM from inadvertently overdoing it or just a wandering baseline due to other reasons (see below) I don't know. I do know it's not deconditioning - you can hardly recondition within 24 hours by doing nothing.

I think it can be hard to be objective about symptoms and levels of functioning. My wife can see the changes in me that I characterise as the "ups and downs" even when I can't. It's like seeing someone's face daily vs not seeing them for two years. I'm an optimist (still!) but this probably hinders me in recognising deterioration until it's overt. I can say I had a deterioration over July which seems to be improving again, but it took me a while to realise it was happening. I think wearable devices have the potential to highlight these changes. The graphs above do suggest that things are looking up again latterly. There was an associated increase in neuroinflammatory type symptoms of hypersensitivity and headache.

I don't know why. My recovery trajectory (if we can grace it with the term) feels like symptoms settling as a damped sine wave. For my mental model it seems as if auto-antibodies are settling and then rise again but not as much, which I see manifested in increasing/decreasing POTS symptoms along with fatigue. I don't know if any of that is what is actually happening though.

I am taking the usual supplement supports that people seem to try early on, plus a couple of prescribed and non-prescription medications that I think are relevant, helpful or at the least vascular-protective. I think any change to the regimen can upset the compromised system, and initially there often seems to be a deterioration before improvement. I'm carefully feeling my way with this, for the guidance is sorely lacking and I'm relying on evidence that is either high quality but very limited in scope or low quality, anecdotal data that make sense to me.

What did I do just before July? I had added in a platelet blocker again, but I had taken that previously with apparent symptom improvement at the beginning of the year. Perhaps it resulted in mast cell triggering? Possibly more relevant though I've been trying to promote autophagy over the last three months, so worked up to an 18/6 (or at least 16/8) intermittent fasting and low carb protocol. I did try a one-off bigger fast previously but that was "grim". I have not tried a pharmaceutical autophagy promoter. My rationale is to try and induce mitophagy, turn over the busted mitochondria and try and improve both metabolic performance and get intracellular control of on-board EBV or whatever has broken free from my immune system. Again, I don't know if these things are sensible / supported, but it makes sense to me to try some things, within reason.

Of course it's possible that we simply can't do autophagy, if the pathways are broken as suggested here. In that case we're between a rock and the proverbial if that were the only way out. Roll on the scientific understanding.

 

[FMMM1]

Seems like evidence against the presumption of distorted cognition in patients, and for CBT actively distorting cognition in patients.

Yea I assume that's why folks like Brian Hughes highlight that unblinded studies, with subjective outcome criteria (questionnaires), are unreliable. I think Jonathan Edwards highlighted the placebo effect in his evidence to the PACE guideline review.
So basically they're telling you this treatment [CBT] works, you've received the treatment, fill in the questionnaire!

EDIT - thanks for the heads up-bit worried that the BPS folks will use this as "evidence" that questionnaires are reliable outcome indicators i.e. in unblinded studies.

 

[FMMM1]

It occurs to me that folks like Fluge and Mella (this group) are reliable scientists - others are consistently unreliable.

 

[rvallee]

The correlations between steps per day and self-reported SF-36 Physical function, SF-36 Social function, and DSQ-SF were significant.​

Interesting contrast to Wiborg's finding of no correlation between self-report fatigue and actimeter/actigraph results (for CBT intervention).

"Although CBT effectively reduced fatigue, it did not change the level of physical activity. Furthermore, changes in physical activity were not related to changes in fatigue."​

So, without that cognition modifying intervention patients are accurately reporting activity levels. With that cognition modifying intervention they are not.

Seems like evidence against the presumption of distorted cognition in patients, and for CBT actively distorting cognition in patients.

Which obviously should be the first thing to consider, that encouraging people to incorrectly report would yield incorrect reports.

It's amazing that this discrepancy has somehow lead to the absurd conclusion that it must be the objective data that are wrong. Hard to find a bigger red flag of pseudoscience than this: yes, the data show us wrong but we know better because we encourage them to report incorrectly. And it worked! Incredible.

 

[bobbler]

Yea I assume that's why folks like Brian Hughes highlight that unblinded studies, with subjective outcome criteria (questionnaires), are unreliable. I think Jonathan Edwards highlighted the placebo effect in his evidence to the PACE guideline review.
So basically they're telling you this treatment [CBT] works, you've received the treatment, fill in the questionnaire!

EDIT - thanks for the heads up-bit worried that the BPS folks will use this as "evidence" that questionnaires are reliable outcome indicators i.e.in unblinded studies.

And do it quickly before you relapse and finally admit to yourself that is what it is (after going through the self-kiddery of 'maybe it's a virus', 'maybe it is the dark', 'maybe it is short term as I've done too much', 'maybe it is something else', 'maybe I don't have CFS at all because my pattern doesn't follow what I'm told it should after all so I don't want to influence the results')

It's not just the encouraging distorted thinking, it's the encouraging the wrong type of people with the wrong attitude to be around those with CFS. It's awful to realise that you talked to someone who wasn't hearing what you said because they arrogantly believed they just needed to give you 5mins speaking to pretend but they knew better and if what you said differed from it then it was you.

Objective is a big step forward. But for me only over long time periods that accommodate for lack of leeway and the impact coming months down the line from not being allowed to reduce activity but it taking its toll brutally and slowly. I also second that the patterns are probably most interesting so anything that makes detail finer here will be useful.

On the other hand I haven't looked at this in detail but do think there needs to make sure there is careful moving on of methodology in these things, because of PEM and because so many are abandoned and their health isn't given leeway meaning what they do re: movement in a day is dictated by pain, injuries and essential to life tasks noone else will help with (telling themselves they are doing you a favour by refusing with weird ideological ideas) cropping up - and the more decrepit you are at that point the less efficiently you can do those. That's why I'd like 'illness measures' - whether that is HR for doing an activity and other things to be developed to describe this more effectively.