Graded exercise therapy compared to activity management for paediatric [CFS/ME]: pragmatic randomized controlled trial, 2024, Gaunt, Crawley et al.

Does this rewriting of Activity Management protocol over time represent an attempt to escape the NICE rejection of GET? Certainly I can’t see that this Graded Cognitive Exercise Therapy could in real life be anything but GET.

This is not even an attempt to disguise ‘pacing up’ as pacing as understood by patients. Does Prof Crawley envisage this leading to recommendations for clinical intervention or is it a desperate attempt for this study not to appear a complete failure?

 

This is a complete mish-mash of various things with zero coherence.

It's the complete opposite of the "all other things being equal" in scientific studies. It's as close to a naturalistic study as you can get. It's not controlled, they still call it that for some reason. It's highly biased. It compares a useless treatment model with something that isn't a treatment model, but can't be considered a neutral or sham control. There is nothing to conclude from this study, which is basically the norm in biopsychosocial land. They simply make their experiments so convoluted and arbitrary that it's impossible to evaluate, compare or conclude anything. Which allows them to conclude whatever they want, as here they suggest that GET probably failed because it wasn't intensive enough.

And nearly a decade for this turd. All they do is waste time while they dick around with their junk and us patients continue to rot away or die. It's all so outrageous but it just goes on and on anyway.

 

Oy! I guess we have a lot to look forward to!!

 

But does that matter to these people? As long as both therapies were equally useless, anyone should be able to get the jobs as therapists, since skills won't matter. That will lead to increased employment. I think we can all agree that increased employment is good.

 

Is there any info on how this was explained to trial participants and their families ?

 

Such an app may even help some people, though not as intended. Every now and again I come across people with ME on social media who say things like: ‘When things start getting bad I do two weeks of GET and that sorts things out’. My interpretation of this, given talking of two weeks of GET is nonsensical, is that such people use the concept of using the idea of reducing activity to a stable baseline and stop there, making it effectively a tool to reduce activity and pace, not a tool to ultimately increase activity.

Having this in app form leaves the person freer to adapt it into something useful, rather than having a therapist taking them back to the unhelpful ‘correct way to do it’.

 

This

 

Haven’t caught up on the thread so don’t know if the cost has been discussed. I saw this on Twitter

Edited to add: https://www.bristol.ac.uk/academic-child-health/research/research/cfsme/magenta/magenta-trial/faq/

 

https://fundingawards.nihr.ac.uk/award/SRF-2013-06-013





"...and start the work needed to establish a trial for severely affected children."

https://www.rcpch.ac.uk/sites/default/files/2019-02/protocolcard_cfs_04022019.pdf

SEVERE PAEDIATRIC CHRONIC FATIGUE SYNDROME OR MYALGIC ENCEPHALITIS (CFS/ME)

The study is funded by The National Institute for Health Research (Senior Research Fellowship, SRF-2013-06-013) and a grant from the Royal United Hospitals Bath NHS Foundation Trust.

 

I wouldn’t be surprised if this isn’t already available in my corner of this green and pleasant land. They were ahead of game here with IAPT badly photocopied work sheets replacing counselling decades ago.

Edit: decades maybe a slight exaggeration, but at least a deal more than a decade.

 

The interesting takeaway for me is that this is evidence that contradicts the argument from the opponents to the NICE guideline that GET can be offered because it isn’t done with fixed increments in clinical practice (i.e. the PACE trial version of GET as described in the guideline) — this trial shows that any variant of GET is ineffective and can cause deterioration (since “activity management” is a “softer” form of GET rebranded under another name).

It is also staggering that with a mean of just 4 GET sessions, 27% of the participants in the intervention group reportedly deteriorated. Surely, any healthcare professional reading this should want to avoid GET.

 

Evidence to add to our thread on why GET is bad for people with ME. Perhaps we should be asking Crawley et all to sign our petition on withdrawing the current Cochrane Exercise Review as they have provided evidence towards the harm it can do.

 

It takes very little to harm people with GET. There have been anecdotal reports of people who went from moderate to severe after just one session.

 

https://www.bristol.ac.uk/academic-...arch/cfsme/magenta/magenta-trial/magenta-pis/

MAGENTA study documents for participants

Patient information sheets

All our patient information sheets have received ethical approval and were developed with support from with the CFS/ME Patient Advisory Group (PAG). The information sheets have been designed with the patient's age in mind and as such we have three different versions which can be viewed below:

Patient Information Sheets for Participants Aged 8- 11 Years of Age PIS 8-11 (PDF, 270kB)

Patient Information Sheets for Participants Aged 12- 17 Years of Age ‌PIS 12-17 (PDF, 354kB)

Parent/ Carer Information Sheet ‌PIS parent/ relative (PDF, 376kB)



Patient Information Sheets for Participants Aged 12- 17 Years of Age ‌PIS 12-17 (PDF, 354kB)

"In addition you will get either Activity Management or Graded Exercise Therapy.

"Activity Management

If you are in this group you will have a detailed assessment of the activity you do. This includes thinking activity such as school work, homework, time on the computer and screens, reading and hobbies that require concentration and physical activity such as walking or PE. We call MAGENTA PIS 12-17 31082016 v0.9 3 this high energy activity. We will ask you to record your activity on paper or our iPhone app “ActiveME”. We will then help you find your “baseline” activity which is the average amount of activity that you can do each day. When you have found your baseline activity, we will help you increase this by 10-20% each week. This is called activity management. Graded Exercise Therapy If you are in this group you will receive a detailed physical assessment including how far you can walk in 2 minutes and how many times you can move from sitting to standing in one minute. This will help us set a safe exercise programme. You will be asked about the exercise you do each day and will be helped to find you exercise baseline. The baseline is the average amount of exercise you do each day. It will be less than you do on a good day. When you have found your baseline, we will ask you to slowly increase you exercise. When you are able to do 30 minutes each day, we will increase the intensity of your exercise. You will be asked to record exercise using either charts or the iPhone app ActiveME. You will not be asked to record other activities, only your exercise. To make sure you do not over do your exercise, we will ask you to use a heart rate monitor.

"What is the difference between Activity Management and Graded Exercise Therapy?

"Activity Management will mainly be working on activities that take up most of the day like school work. It does not focus on exercise or include a physical assessment or heart rate monitoring. Graded Exercise Therapy gives detailed advice about exercise with an assessment of your exercise and uses a heart rate monitor. Graded Exercise Therapy will not ask you to monitor other activities such as school work."


From the info sheet for parent/carers:

"Children in both groups will be asked to wear an accelerometer. This is a small box that they will wear on a band around their hips. Lots of young people have used these to measure exercise. We may ask your child to record when they wear it and when they take it off. In addition, your child will get either Activity Management or Graded Exercise Therapy Activity Management If your child is in this group they will have a detailed assessment of the total activity they do each day. This will mainly be thinking activity such as school work, homework, time on the computer and screens, reading and hobbies that require concentration. It will also include the amount of time spent doing physical activity such as walking or PE but we will not ask for any detail of exercise or for this to be recorded separately. We call all of this “high energy activity”.

"We will ask your child to record this on paper or our iPhone app “ActiveME”. We will then help them find their “baseline” activity which is the average amount of activity that they do each day. When your child has found their baseline, we will help them increase their activity by 10-20% each week.

"Graded Exercise Therapy

"If your child is in this group your child will receive a detailed physical assessment including how far they can walk in 2 minutes and how many times they can move from sitting to standing in one minute. This will help us set a safe exercise programme. Your child will be asked about the exercise they do each day and will be helped to find their exercise baseline. The baseline is the average amount of exercise they do each day. It will be less than they do on a good day. When they have found their baseline, we will ask them to slowly increase their exercise. When they are able to do 30 minutes each day, we will increase the intensity. They will be asked to record exercise using either charts or the iPhone app ActiveME. They will not be asked to record other activities, only their exercise. To make sure your child does not over do the exercise, we will ask them to use a heart rate monitor.

"What is the difference between Activity Management and Graded Exercise Therapy?

"Activity Management will work on the total amount of activity done each day. This is mainly thinking activities. It does not provide specific advice about exercise include a physical assessment or heart rate monitoring. Graded Exercise Therapy provides specific advice about exercise with a physical assessment and uses heart rate monitoring."

 

An ethical committee approving this is perhaps unsurprising, but, even though I was aware that Prof Crawley had a long-standing hand-picked PAG, it still seems disconcerting that patients or parents/guardians would support this research.

However, we also see the opaque Sussex and Kent ME/CFS Society, very much an outlier amongst local groups, with a disconcerting number of geographically scattered medical advisors including Bristol based Prof Crawley, supporting use of exercise based intervention.