What ME research has used actimeters/Fitbits?

[Sasha]

We've been discussing on another thread the notion that it would be a good idea to establish better data about the natural course of ME over time via the use of actimeters (a popular, commercially available one is the Fitbit). This would help in the design of RCTs.

A hundred would probably do. Maybe we should write a grant application - if we could get 100 Spanish PCEM (personas con encefalitis miálgica) and 100 Norwegian MMME (mennesker med myalgisk encefalitt) we could get an EU grant. I was never that good at that but I might know a man that is.

Does anybody know if these Fitbits have actually been used in trials on PWME yet, or is everyone just talking about it?

I don't know about Fitbits specifically but actimeters were used in a European trial of CBT &/or GET that preceded PACE and demonstrated a lack of effect (hence the scandal over them being planned for PACE but dropped).

I think Fluge & Mella are using actimeters in their current Rtx trial (which you'll know all about).

I think that if they have been used up til now it will most likely have been in the context of CBT/GET trials and possibly sensible studies of activity in relation to the CPET/VO2 max PEM work.

@@Tom Kindlon? Do you know about this?

...actually I just searched within the forum and here's Dr Enlander in NY using Fitbits in his research:

http://forums.phoenixrising.me/index.php?threads/is-cdc-out-to-bury-pem.31292/page-5#post-481650

Anybody else know of any more?

 

[Sasha]

@Jonathan Edwards - both 'actimeter' and 'actometer' appear to be correct spellings - don't know if that will help on Pubmed.

 

[Sasha]

From an old thread:

http://forums.phoenixrising.me/index.php?threads/actimeter-data.15012/#post-244449

This paper releases actometer readings from three prior studies which had been presented as showing CBT to be effective, and it was only 9 years (I think) after the first study was released that we got the actometer readings showing no improvement in activity levels.

[edited for order of authors] "Wiborg JF, Knoop H, Stulemeijer M, Prins JB, Bleijenberg G." so "Wiborg et al., 2010". 'How does cognitive behaviour therapy reduce fatigue in patients with chronic fatigue syndrome? The role of physical activity.' Psychol Med. 2010 Aug;40(8):1281-7.

 

[Sasha]

More from that thread:

Identifying physical activity patterns in chronic fatigue syndrome using actigraphic assessment.
http://www.ncbi.nlm.nih.gov/pubmed/11164063

J Psychosom Res. 2000 Nov;49(5):373-9.
Identifying physical activity patterns in chronic fatigue syndrome using actigraphic assessment.
van der Werf SP1, Prins JB, Vercoulen JH, van der Meer JW, Bleijenberg G.
Author information

Abstract
OBJECTIVE:
Changes in physical activity are thought to play an important role in maintaining symptoms in chronic fatigue syndrome (CFS). The aim of this study was to describe intraindividual physical activity patterns in more detail and to identify pervasively passive patients.

METHODS:
With help of a movement-sensing device, physical activity levels were registered continuously over a 12-day period in 277 CFS patients. Within this registration period, the 10 largest activity peaks were computed. The intensity and duration of these activity peaks and their subsequent rest periods were described and compared to those of 47 healthy controls. In addition, the patients' 12 daily activity scores were used to identify patients who were characterised by low levels of physical activity throughout the registration period.

RESULTS:
The CFS sample had less intense and shorter activity peaks, while the average rest periods that followed these peaks lasted longer. Approximately one-fourth of the CFS sample differed distinctly from the control group and was labelled as pervasively passive.

CONCLUSION:
The measurements and classification of actual physical activity levels were found to reduce heterogeneity in the CFS population and therefore could provide the opportunity to optimise behavioural intervention protocols for CFS.

PMID:

11164063

[PubMed - indexed for MEDLINE]

 

[Sasha]

@Tom Kindlon, @Esther12, can you help at all?

 

[A.B.]

We've been discussing on another thread the notion that it would be a good idea to establish better data about the natural course of ME over time via the use of actimeters (a popular, commercially available one is the Fitbit). This would help in the design of RCTs.

What exactly are we looking for in other studies?

To clarify: I think the questions should be defined before we attempt to find the answers. We know that other studies have used actimeters.

 

[Sasha]

What exactly are we looking for in other studies?

Excellent question!

@Jonathan Edwards, I'm finding via Google quite a few references to studies of various kinds involving PWME and actimeters, though not necessarily RCTs and not necessarily published.

Presumably you don't want just any old grab-bag of rubbish. What would you like to see?

 

[Sasha]

Actually, @Jonathan Edwards, in the context of what we were talking about on the other thread:

There is, however, another problem that has just surfaced in my mind. ME fluctuates much more than a lot of autoimmune disease symptoms I suspect. It may be a bit like lupus that has 'flares' and plateaus, or MS with 'episodes' and recoveries. These conditions are difficult to make sense of in time curve terms after treatment whether the measure is objective or subjective.

The basic problem is that ME is about the most difficult thing one could need to assess in a trial situation. Which is why other notable trials have come up with a lemon. I have a feeling that we need completely different sorts of trial designs for this condition, but I am not quite sure how best to approach it.

I've been thinking that if prospective patients in a trial get considerable notice that they might be in a trial (as @deleder2k did, I think), then they could be issue with actimeters at that point and start wearing them continually so that there's a pre-trial baseline established of at least several months, which could help to interpret their post-treatment response.

Given your ideas about different types of ME, I wonder if this kind of data would show differences between subtypes in terms of whether their activity is basically just stable for years or shows lots of fluctuation (a different issue to what we were discussing, but I'm thinking a bit more generally about the uses of a non-intervention actimetry study of PWME).

 

[Jonathan Edwards]

It does look as if ME/CFS researchers prefer actometer whereas people who study cancer, mice and old people go for actimeter so thanks to Valentijn for the pointer. It looks as if Dutch groups have done some calibrating studies that indicate that the results from actometers make sense in terms of concurrent questionnaires on activity (or vice versa).

The question I have not yet seen answered is whether actometer readings over a week or two are useful in terms of an assessment of what is happening over a period of months. I have not yet seen what Sasha was suggesting which was to use actometers to see how variable activity is in ME regardless of treatment. This would be relevant to the reliability of any trial data particularly in terms of whether patients tried hard to keep up activity for the week of wearing the actometer and then collapsed into bed for a month. But it would be especially relevant to any attempt to understand treatment responses in terms of time courses - the key issue when it comes to working out how rituximab might be working. And it would be relevant to power estimations for trial design if actometer data were used as primary outcome - since these would depend on variance.

I guess I am thinking in terms of the calibration/validation work that went in to visual analogue scale methods for pain assessment in the 1970s. A lot of preliminary work was done to see whether these assessments could be used just before and after treatment or whether more was needed. I turned out that to be reliable patients really needed to get used to filling in a VAS on several occasions before they started a trial. The issues for actometers would be different but there might be equally important issues about reproducibility of another sort. Vast amounts of time and effort went into VAS research for arthritis drug trials because they were big business. Maybe if actometer data are to be taken seriously similar attention is needed. The problem is justifying that to a funding body rather than pharmaceutical sponsors.

 

[Jonathan Edwards]

Actually, @Jonathan Edwards, in the context of what we were talking about on the other thread:

I've been thinking that if prospective patients in a trial get considerable notice that they might be in a trial (as @deleder2k did, I think), then they could be issue with actimeters at that point and start wearing them continually so that there's a pre-trial baseline established of at least several months, which could help to interpret their post-treatment response.

Given your ideas about different types of ME, I wonder if this kind of data would show differences between subtypes in terms of whether their activity is basically just stable for years or shows lots of fluctuation (a different issue to what we were discussing, but I'm thinking a bit more generally about the uses of a non-intervention actimetry study of PWME).

Clearly some telepathy going on here. I may be naive but it seems to me that this is the sort of basic biological stuff that needs to be set up and worked through in a well described cohort (or three) so that we move beyond unblinded, and in some cases uncontrolled psychotherapy studies.

 

[Sasha]

Julia Newton has received a MERUK grant to look at severely ill PWME and one of the strands is to use 24-hr actimetry, although it's not clear for how long:

http://www.meresearch.org.uk/our-research/ongoing-studies/severely-affected-me-patients/

ME Research UK]Background and aim

Around 10 to 25% of ME/CFS patients are reported to be housebound or bedbound, yet we still understand very little about the origin and outcome of their severe illness. We know, however, that severe illness predisposes patients to secondary medical conditions; that the prospects for recovery tend to be worse for those most severely affected; and that the cumulative impact of severe illness over many years, where there is no sense of improvement, can be profound. Because of all this, it is astonishing that the most basic clinical and experimental scientific work has not been carried out on this important subgroup of people with ME/CFS (discussed more fully in our essay,Severely Overlooked by Science).

Prof. Newton and colleagues at Newcastle University are leaders in the assessment of autonomic nervous system dysfunction in a range of diseases, and since 2006 they have received 6 project awards from ME Research UK to advance our understanding of ME/CFS. In an impressive series of scientific papers, they have uncovered a range of biological anomalies, and their main finding has been that autonomic nervous system dysfunction contributes significantly to the symptom burden and quality of life of ME/CFS patients, affecting standing, blood pressure regulation, muscle function and cognition. Their research culminated in an award from the Medical Research Council to explore the relationship between autonomic nervous system impairments and the neurocognitive symptoms (including deficits in memory and attention) which are some of the most frequent and disabling symptoms associated with ME/CFS.

For many years, ME Research UK and Prof Newton have been concerned about the chronic lack of research interest into severe ME/CFS, and the serious void that exists in the scientific knowledge-base about this group of patients. So, when ME Research UK awarded a large programme grant to the researchers in Newcastle in 2014 (photo), it was decided to initiate a specific project investigating housebound or bedbound individuals who are unable to attend clinics or take part in research projects (which often require hospital attendance and multiple visits).

The two-year project will be conducted day-to-day by the newly funded ME Research UK Research Associate, and will involve:

1. Identification of severely affected ME/CFS patients from records of the Newcastle Clinical Service, local patient support groups including ME North East, and national registers or other sources. This will give an indication of how common severe ME/CFS is in this particular area of North-East England, and identify specific patients to be included in the investigation.
2. Home visits on patients. During each visit, the ME Research UK Research Associate will undertake a series of specific assessments, including:
   • Recording of demographic information, such as length of illness, mode of onset, provision of social care, receipt of benefits etc.
   • Autonomic testing at rest to gauge the presence of autonomic nervous system dysfunction, which features prominently in ME/CFS patients generally.
   • ME and CFS diagnostic criteria assessment, using the DePaul Symptom Questionnaire in collaboration with Prof. Leonard Jason at De Paul University in Chicago.
   • Neurocognitive testing (e.g. memory, concentration and executive function) using software-based tools, since neurocognitive symptomsare some of the most common and worrying for ME/CFS patients.
   • Assessments of muscle strength, using dynamometer and manual physical techniques.
   • Activity monitoring using a 24-hour actimeter.
   • Asessment of symptoms, including information from sleep and activity diaries.
   • Recording of patients’ own experience of illness and treatment, and the impact of the disease.

This aim of this exploratory study is to raise the curtain on this severely overlooked group of patients, defining their clinical characteristics, gauging the level of unmet clinical need, and determining the relationship, if any, between autonomic nervous system dysfunction and other clinical variables. Subsequent progress will depend on what these investigations uncover and where the science leads. Crucially, however, a start will have been made on the serious scientific investigation of housebound and bedbound people with ME/CFS.

 

[Esther12]

@Tom Kindlon, @Esther12, can you help at all?

I'm not aware of any studies looking at natural course with actometers.

The closest we have is probably those CBT RCTs that had a control group.

Some other bits of possible interest:

This:

Association between cognitive performance, physical fitness, and physical activity level in women with chronic fatigue syndrome.

J Rehabil Res Dev. 2013;50(6):795-810. doi: 10.1682/JRRD.2012.08.0156.

Ickmans K1, Clarys P, Nijs J, Meeus M, Aerenhouts D, Zinzen E, Aelbrecht S, Meersdom G, Lambrecht L, Pattyn N.

Author information

Abstract

Limited scientific evidence suggests that physical activity is directly related to cognitive performance in patients with chronic fatigue syndrome (CFS).

To date, no other study has examined the direct relationship between cognitive performance and physical fitness in these patients.

This study examined whether cognitive performance and physical fitness are associated in female patients with CFS and investigated the association between cognitive performance and physical activity level (PAL) in the same study sample.

We hypothesized that patients who performed better on cognitive tasks would show increased PALs and better performance on physical tests.

The study included 31 women with CFS and 13 healthy inactive women.

Participants first completed three cognitive tests.

Afterward, they undertook a test to determine their maximal handgrip strength, performed a bicycle ergometer test, and were provided with an activity monitor. In patients with CFS, lower peak oxygen uptake and peak heart rate were associated with slower psychomotor speed (p < 0.05).

Maximal handgrip strength was correlated with working memory performance (p < 0.05).

Both choice and simple reaction time were lower in patients with CFS relative to healthy controls (p < 0.05 and p < 0.001, respectively).

In conclusion, physical fitness, but not PAL, is associated with cognitive performance in female patients with CFS.

Comment in

Rebuttal to Ickmans et al. association between cognitive performance, physical fitness, and physical activity level in women with chronic fatigue syndrome. J Rehabil Res Dev. 2013;50(6):795-810. www.rehab.research.va.gov/jour/ 2013/506/pdf/ickmans506.pdf. [J Rehabil Res Dev. 2013]

Response. [J Rehabil Res Dev. 2013]

PMID: 24203542 [PubMed - indexed for MEDLINE]

Was discussed here:

http://forums.phoenixrising.me/inde...ess-and-physical-activity-level-in-cfs.31644/

Some data from teens in "Cognitive idiosyncrasies among children with the
chronic fatigue syndrome: anomalies in self-reported activity levels" discussed here:

http://forums.phoenixrising.me/inde...tations-of-their-childs-iq.22629/#post-347633

A trial for some sort rehabilitation of 'unexplained' fatigue that used actometers is discussed here: http://forums.phoenixrising.me/inde...program-the-4-steps-for-unexplained-cf.32694/

This 1997 paper looked at actometer results for CFS and MS: http://www.ncbi.nlm.nih.gov/pubmed/9447571

I'm sure there was another semi-recent paper which had data on low activity levels for CFS that I can't remember the details of right now.

There are a few other bits which sound even less related to what you're interested in than the above.

 

[Sasha]

Thanks, @Esther12.

@Jonathan Edwards - I wonder if there's any mileage in trying to tag onto Julia Newton's study, depending how big it is, and getting patients to use those actimeters for a usefully long period for your purposes?

 

[Jonathan Edwards]

It sounds as if Julia Newton's group have set up the infrastructure that could be used to do this, which is encouraging. It does not indicate in the memo you posted whether there would be longitudinal assessments but that would seem to be one of the things they might pursue next if they gather a cohort together.

 

[Valentijn]

It looks as if Dutch groups have done some calibrating studies that indicate that the results from actometers make sense in terms of concurrent questionnaires on activity (or vice versa)

It depends on whether or not the questionnaires are being applied after extensive brainwaishing (Dutch CBT). Dutch CBT patients are directly encouraged to stop seeing and labeling themselves as ill or disabled, and to ignore symptoms and attribute them to something other than illness. Thus after many of these sessions they will often be obedient little patients and exaggerate their physical capacity quite a bit on questionnaires.

But actometers contradict the subjective claims of improvement. Hence in the case of CBT, the results from actometers and questionnaires have been shown to diverge markedly (bizarre CBT research conclusion: an increase in physical activity doesn't mediate the supposed curing of "fatigue").

The question I have not yet seen answered is whether actometer readings over a week or two are useful in terms of an assessment of what is happening over a period of months. I have not yet seen what Sasha was suggesting which was to use actometers to see how variable activity is in ME regardless of treatment. This would be relevant to the reliability of any trial data particularly in terms of whether patients tried hard to keep up activity for the week of wearing the actometer and then collapsed into bed for a month.

While it can happen that we have a slow-motion crash after a week or more of consistent increased activity, that's usually due to very slight and constant pushing. And even then, I think it's pretty rare, especially in absence of a deliberate GET program. 99% of the time, we crash much faster.

 

[alex3619]

Quite apart from a baseline for a medical treatment study we could really use long term activity data for patients in a large cohort. Such information would have its own value.

 

[lansbergen]

When I first heard about the actometers I tried to figure out if it would registry the unvoluntary movements I had a lot at that time.

I still do not know what exactly it measures. What activity is measured?

I like gardening and when I am weeding I sit on my knees, I do not make steps and/or big arm movements and/or big posture changes.. When I am working on the computer I do not move my legs and my arms only make small movements. When I lie down trying to make sense of the information I gathered I do not move at all.

I wish the breathing muscle movements could be measured. Mine were very impaired.

 

[taniaaust1]

Im probably off track as my brain hasnt been able to grasp what this thread is about but I wanted to say that Dr Richard Kwiatek. Adelaide, Sth Australia Rheumatologist (ME/CFS specialist).. is his current ME study (they use canadian diagnostic criteria so I'll call it a ME study thou its a ME/CFS one) .. he's using (with my brain not working I dont know if its called the things beign talked about here) those things which measures activity which one wears strapped to an ankle. We had to wear one on the ankle I think it was for one week.. it was worn full time (24hrs per day).

In my case my activity level in this study when its published, would be higher then normal as during the study seeing other tests were being done, I wanted to try to make sure any ME abnormalities would show up on the other tests in the study eg on the brain tests etc so I did more physical activity during the study week then I period then I usually would do, not caring if I got ill. (my second lot of brain tests with a neuropsych was quite shocking, my brain decline on tests even shocked me).

Thou my activity level still would of been quite dismal. (I was feeling wiped out by this study period after it due to my pushing my normal limits a bit but actually didnt have a big crash from pushing myself on this occassion).

anyway.. I want to point out what I did in this study as possibly others would do this to if other tests are also being done.. which may give an increased activity level if ME/CFS people are purposely trying to make themselves worst by doing more so hopefully the ME abnormalities show in a study.

I found it hard recording my activities in writing so that too would be confusing in that study seeing Im sitting, standing, laying all over the place all day.. may do a physical on feet activity for only a few mins at times before sitting down or laying again. It made it very hard to record what I was doing when I only do physical stuff on and off all day for very short periods.

And also when I did record on my activity sheet a standing or upright activity going on.. there would of been many points during it in which I layed down for a few minutes or sat for 5-10 mins... so even with written records it would be hard to have an accurate record of what person was doing.

I think to get a more accurate record of someones activity levels.. one would need to monitor them for at least couple of weeks with an activity monitor. and if watching if someones base line is changing. I think one would need to do this about every 3 mths.

I wonder if my sitting down at computer with my legs up and all the figeting I do around then trying to get comfortable (its hard sitting at computer with legs up), if that would of showed up as activity?

 

[Sasha]

I think that what Prof Edwards is interested in is using actimeters 24 hours a day for a long period of months and to find out what the normal course of the illness is.

Interesting to bear your comment in mind, though, @taniaaust1, if it's being measured in the context of a study where patients might be motivated to behave in an unusual way.

 

[taniaaust1]

I think that what Prof Edwards is interested in is using actimeters 24 hours a day for a long period of months and to find out what the normal course of the illness is.

ah thanks for explaining it.
..........

My normal course of illness varies with things going on in my life, so it would depend on how many things in my life were going on in which I had to over exert myself in eg is there a lot of family birthdays I will get too in those few months? while then I may go a 6th month period without a family do Im pushing myself to be able to go to (so it could even vary a lot comparing one three month period to another). I dont know if there is a "normal course" for my illness.

One interesting period if looking at long term periods like 3mths, would be to look at the couple of months leading up to xmas to the month after that. That is a huge risk period for most of us and many of us will have quite a crash or decline at that time due to xmas. Lots of us spend the month after xmas in trying to recover to our previous baselines.