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

[Hutan]

ETA I agree with @Jonathan Edwards .
This keeps the money flowing , and with long COVID likely coming under existing " specialists" umbrellas , this is justification for continuance .

The queen is dead, long live the queen

I was about to disagree, as surely a health system that is on its knees does not need to be wasting money on therapy that doesn't work, but here's the conclusion:

We did not show a difference between GET and AM, or a substantial improvement in physical function with either intervention. This lack of improvement in physical function may be explained by the low intensity of therapy sessions.

Translation: we still couldn't make it work, but give us more research money, a lot more research money, and more clinical funding too, and we'll give it another go.

Edit: I'd like to nominate that last Gaunt et al quote for an annual award - I'm not sure what the name of the award would be. Maybe 'Deepest denial'? Maybe we do need some annual awards.

 

[Hutan]

Given the ridiculous conclusion, suggesting that the problem was just that the young people didn't get enough time with the therapists, I have to post this chart from Supplementary File 1


I can't see any trend of young people with 8+ sessions of GET doing better than the young people who only had 0-2 sessions.

 

[Amw66]

Given the ridiculous conclusion, suggesting that the problem was just that the young people didn't get enough time with the therapists, I have to post this chart from Supplementary File 1

View attachment 21285
I can't see any trend of young people with 8+ sessions of GET doing better than the young people who only had 0-2 sessions.

" low intensity " . Is this number of sessions or the type of session ...

 

[Amw66]

I was about to disagree, as surely a health system that is on its knees does not need to be wasting money on therapy that doesn't work, but here's the conclusion:

Translation: we still couldn't make it work, but give us more research money, a lot more research money, and more clinical funding too, and we'll give it another go.

Exactly this .
It's how it's always worked .

 

[Hutan]

"low intensity" Is this number of sessions or the type of session ...

Yes, possibly the 'intensity' doesn't refer to the number or frequency of the sessions, but instead the 'toughness' of the sessions. Maybe they are suggesting that they should have been less lenient with symptom contingency, and encouraged the young people to push through more.

 

[Amw66]

Yes, possibly the 'intensity' doesn't refer to the number or frequency of the sessions, but instead the 'toughness' of the sessions. Maybe they are suggesting that they should have been less lenient with symptom contingency, and encouraged the young people to push through more.

It's GET - light .
How many would have rolling PEM without knowing it

 

[Hutan]

From the discussion re 'intensity':

These results must be interpreted in the light of the pragmatic nature of the study in which, for the majority of participants, sessions took place over 12 months with up to 6-week intervals, reflecting the reality of delivering interventions for paediatric ME/CFS within the NHS.

Sounds as if they are suggesting that the problem was the frequency, with sessions too spread out.

 

[Amw66]

If the number suggestion is correct then this is potentially a lot worse .
Not had a good night here so not up to reading paper itself



And what happened to the 100+ participants who didn't fill in questionnaires at 12 months? Did anyone check to see if they were any worse?

 

[Hutan]

For the ones that did fill in the questionnaires at 12 months:

On average, physical function did not improve to a clinically significant degree (which we have previously determined to be a MCID of 10 points [28]) in either group after 6 or 12 months, consistent with the accelerometer data which suggests the MAGENTA participants had a reduction in moderate-to-vigorous-intensity physical activity at 3 and 6 months. Some outcomes did change: fatigue improved in both groups, sustained to 12 months, which may explain why overall, 40% felt they were much better or very much better after a year.

sounds like a process of adjustment to a chronic illness, with both less time doing vigorous physical activity and less fatigue.

 

[Amw66]

Don’t be fooled by fancy names and euphemisms. “Activity management” is a form of coercive control of patients with #LongCovid or #MEcfs. Please RT

 

[chillier]

Given the ridiculous conclusion, suggesting that the problem was just that the young people didn't get enough time with the therapists, I have to post this chart from Supplementary File 1

View attachment 21285
I can't see any trend of young people with 8+ sessions of GET doing better than the young people who only had 0-2 sessions.

I just added a red line to this plot to make it easier to visualise (for me at least). If a dot is above the line they improved if it's below they got worse. If they stayed on the line there's no change. Just a quick approximate count of all the data points above and below the line:

Activity management: 43 above, 44 below
GET: 46 above, 44 below

For both categories there are more red dots (people who did 0-2 sessions) above the line than below (so doing nothing looks like the best strategy). For the GET I count something like 13 blue (people who did 8+ sessions) dots below the line and 8 above - so around twice as likely to feel worse after GET at 6 months follow up than to feel better.

 

[Amw66]

For the ones that did fill in the questionnaires at 12 months:

sounds like a process of adjustment to a chronic illness, with both less time doing vigorous physical activity and less fatigue.

Indeed.
That's the logical explanation . Yet to see a " penny drop " moment from this team though .

 

[chillier]

View attachment 21288

I just added a red line to this plot to make it easier to visualise (for me at least). If a dot is above the line they improved if it's below they got worse. If they stayed on the line there's no change. Just a quick approximate count of all the data points above and below the line:

Activity management: 43 above, 44 below
GET: 46 above, 44 below

For both categories there are more red dots (people who did 0-2 sessions) above the line than below (so doing nothing looks like the best strategy). For the GET I count something like 13 blue (people who did 8+ sessions) dots below the line and 8 above - so just under twice as likely to feel worse after get at 6 months follow up that to feel better.

The trend if anything looks to me like the fewer sessions you had the better your chances of improvement - for both activity management and GET.

 

[Amw66]

???
How on earth do you make sense of any " treatment"


ETA a bit concerning re CBT being needed / used for subjects developing anxiety and/ or depression during the trial .
As we know many scales used for such diagnosis are inappropriate as symptoms are misinterpreted .
The power asymmetry is never acknowledged . The stress these families are under is also poorly acknowledged.
Many are in a classic double bind situation.

I hope that they got appropriate help .

 

[Sid]

Comparing participants with measured outcomes in their allocated groups, the mean SF-36-PFS score changed from 54.8 (standard deviation 23.7) to 55.7 (23.3) for GET and from 55.5 (23.1) to 57.7 (26.0) for AM

They're going to have a hard time spinning this as GET and activity management being "equally effective" since neither was effective and the scores didn't budge in either group.

It looks like it took them 9 years since trial registration to conduct the trial and report it. My goodness. I wonder if the huge delays are due to the results being unfavourable to them.

 

[Lucibee]

Here are the descriptions of the therapies from the supplementary material provided with the 2019 protocol paper: https://bmjopen.bmj.com/content/6/7/e011255

Arm 1: Activity Management
Mandatory elements: Therapists will discuss the different types of cognitive activity (high concentration and low concentration) which will vary according to age.
Participants will be taught how to find their baseline of cognitive activities.
Cognitive activities include time at school or doing school work, reading, some craft/hobbies, socialising and screen time (phone, laptop, TV, computer, other devices).
The baseline is the median time spent doing cognitive activity and can either be estimated in collaboration with the specialist therapist or calculated after a period of recording activity.
Once the baseline is agreed with participants, they will be asked to record the total number of minutes spent each day doing high-energy cognitive activities using paper diaries or our award-winning smartphone app “ActiveME”.
Recording activity is used to help participants understand whether they are doing the same each day or varying their activity and whether the baseline has been set at the correct level.
When participants have managed the baseline for 1-2 weeks, they will be asked to increase this by 10-20% each week.
Therapists will discuss problems encountered by participants and provide possible solutions.
Managing setbacks will be discussed (how much to reduce school and other cognitive activity and for how long).
Participants will continue to increase activity until they are able to do at least 8 hours of cognitive activity a day.

Prohibited: Discussion about number of steps, minutes of exercise, aerobic, versus non aerobic activity.
No discussion about increasing physical activity (only discussion about increasing overall activity).
No advice on exercises or using a strengthening programme.

Flexible: Advice on Physical Education (PE) in school (no PE, half a lesson, full lesson).
Attendance at sporting events (do not attend, attend limited period of time).
Children and young people can record physical activity within the total cognitive activity but are not required to do so.

Arm 2: Graded Exercise Therapy
Mandatory: Physical assessment, assessment of range and type of exercise used during the week at the first assessment.
Functional muscle test at assessment and 6 months including: sit to stand and 2 minute walk test (distance covered).
Exercise targets will be negotiated with the child and parents/carer. Initial exercise targets (the baseline) will be the median amount of daily exercise done during the week.
Once this is achieved every day for one to two weeks, participants will be advised to increase exercise slowly by 10-20% a week.
They will be asked to time their exercise to make sure they are completing the same number of minutes of exercise every day and record these minutes of exercise each day using either paper diaries or our smartphone app “ActiveME”.
Diaries (paper or using ActiveME) will be reviewed to help children ensure their exercise is the same every day.
Once participants are doing 30 minutes of planned exercise within the low intensity heart rate limits (such as slow paced walking), the exercise will increase in intensity such that participants start doing exercise that increases their heart rate (for example faster paced walking, cycling).
The exercise programme will be negotiated and agreed together at each appointment between the therapist, child and adolescent and parent/carer.
Participants aged 10 and over will be taught how to monitor their heart rate using a heart rate monitor to prevent them doing too high an exercise intensity.
They will be set a target heart rate and asked not to exceed this.
Younger children or those who cannot measure their heart rate will learn how to monitor their heart rate with their parents.
Managing setbacks will be discussed prior to discharge in the context of physical exercise (how much this should be reduced and when they should start to do exercise again).
Participants will be encouraged to continue to increase exercise to achieve Department of Health recommended levels of 60 minutes a day of a mixture of moderate/vigorous intensity aerobic with muscle strengthening activities on three days/week.

Prohibited: Advice on cognitive activity, discussion about the different types of cognitive activities.
Instructions to record the cognitive activities.

Flexible: Assessment of range of movement.
Advice on length of time at school (full days, half days, one lesson a day), support increasing time at school.
Advice over exams.
Participants can be shown how to do stretches.
They can also be offered a strengthening programme if this is one of their goals.

And as Trish said 5 years ago...

So they are actually both GET, but with the one labelled as GET more carefully monitored using timing and heart rate monitoring.

 

[Peter T]

Yes, GET by another name:

Arm 1: Activity Management

… … …

Recording activity is used to help participants understand whether they are doing the same each day or varying their activity and whether the baseline has been set at the correct level.
When participants have managed the baseline for 1-2 weeks, they will be asked to increase this by 10-20% each week.

Therapists will discuss problems encountered by participants and provide possible solutions.
Managing setbacks will be discussed (how much to reduce school and other cognitive activity and for how long).
Participants will continue to increase activity until they are able to do at least 8 hours of cognitive activity a day.

Although this focuses on cognitive activity rather than physical exercise, by introducing fixed increments does it run foul of the NICE prohibition of GET.

 

[Sean]

Welcome to the new regime. Same as the old regime.

 

[Evergreen]

Here are the descriptions of the therapies from the supplementary material provided with the 2019 protocol paper: https://bmjopen.bmj.com/content/6/7/e011255





And as Trish said 5 years ago...

So the protocol described AM as essentially graded cognitive therapy, but in this paper they describe AM as a more general graded activity therapy, including both cognitive and physical activity:

Activity management (AM) was provided as a personalised approach that established a baseline (similar every day) level of cognitive (e.g. schoolwork, social activities) and physical activity (walking, any exercise) using diaries. This usually required a reduction in activity on some days. Both physical activity and cognitive activity were then gradually increased as participants were able. If participants’ symptoms increased, they were advised to keep activity constant or reduce activity (cognitive and physical). Sessions were delivered by health professionals including specialist doctors, psychologists, physiotherapists, occupational therapists and nurses.[my bold]

 

[Evergreen]

Here are the descriptions of the therapies from the supplementary material provided with the 2019 protocol paper: https://bmjopen.bmj.com/content/6/7/e011255





And as Trish said 5 years ago...

And in the protocol paper itself AM is described differently to in the documents @Lucibee quoted:

Activity management aims to convert a ‘boom–bust’ pattern of activity (lots 1 day and little the next) to a baseline with the same daily amount before increasing the daily amount by 10–20% each week. For children and adolescents with CFS/ME, these are mostly cognitive activities: school, schoolwork, reading, socialising and screen time (phone, laptop, TV, games). Those allocated to this arm will receive advice about the total amount of daily activity, including physical activity, but will not receive specific advice about their use of exercise, increasing exercise or timed physical exercise.