Protocol Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM): protocol for a randomised feasibility trial 2024 Simpson

Abstract

Introduction
Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM) is a research programme that seeks to develop and evaluate a comprehensive exercise-based rehabilitation intervention designed for people with multimorbidity, the presence of multiple long-term conditions (MLTCs). This paper describes the protocol for a randomised trial to assess the feasibility and acceptability of the PERFORM intervention, study design and processes.

Methods and analysis
A multicentre, parallel two-group randomised trial with individual 2:1 allocation to the PERFORM exercise-based intervention plus usual care (intervention) or usual care alone (control). The primary outcome of this feasibility trial will be to assess whether prespecified progression criteria (recruitment, retention, intervention adherence) are met to progress to the full randomised trial. The trial will be conducted across three UK sites and 60 people with MLTCs, defined as two or more LTCs, with at least one having evidence of the beneficial effect of exercise. The PERFORM intervention comprises an 8-week (twice a week for 6 weeks and once a week for 2 weeks) supervised rehabilitation programme of personalised exercise training and self-management education delivered by trained healthcare professionals followed by two maintenance sessions. Trial participants will be recruited over a 4.5-month period, and outcomes assessed at baseline (prerandomisation) and 3 months postrandomisation and include health-related quality of life, psychological well-being, symptom burden, frailty, exercise capacity, physical activity, sleep, cognition and serious adverse events. A mixed-methods process evaluation will assess acceptability, feasibility and fidelity of intervention delivery and feasibility of trial processes. An economic evaluation will assess the feasibility of data collection and estimate the costs of the PERFORM intervention.

Open access, https://bmjopen.bmj.com/content/14/4/e083255

 

'‘Health and Well-being’ self-care support sessions aim to support self-management of common symptoms and risk factors and to enhance self-management skills, including problem-solving, planning, self-monitoring and cognitive adaptation. The list of core sessions that will be delivered to participants randomised to the intervention arm (in no particular order) are detailed:

• Exercise is medicine (learning about exercise and its role in staying healthy).
  
  
• Eating for health: staying strong.
  
  
• Better sleep.
  
  
• Lifting your spirits (improving mood/tackling depression).
  
  
• Eating for health: a healthy balanced diet.
  
  
• Managing pain (strategies for reducing pain).
  
  
• Staying active for life (planning for an active future, beyond the PERFORM programme).
  
  
• Stress busting (recognising and addressing stress and anxiety).
  
  
• Breathe easy (reducing breathlessness).
  
  
• Stronger together (increasing/improving support networks).
  
  
• Boost your energy (improving energy levels/reducing fatigue).
  
  
• Making the most of your medications (including ways to identify and manage side effects).
  
  
• Let’s relax (practising relaxation techniques).
  
  
• Coping well (strategies for living well despite having MLTCs)."

 

Aren't researchers generally supposed to not repeat the same research? Expected to look at whether something has been done before, dozens of times in this case, and not simply try again and again the same way with the same intent and purpose? This is a feasibility trial for generic stuff that millions have been subjected to over decades to clear failure. It's completely insane that this stuff continues to get funded without end or purpose.

And that's even when you overlook the pretense that the above amounts to a treatment model. It's completely generic fluff, there are hippie retreats based around the same FFS and it's mostly infantilizing patronizing crap.

 

If they genuinely wanted to assess the effectiveness of things like this for people with multiple long-term conditions, they'd be looking at outcomes over years, not months.

"But but but we can't do that because there are too many variables and we'd have to commit too many resources and we wouldn't get any nice neat answers to make our funding sources happy..."

Yeah. There you are then.

 

I was very disappointed at the lack of a bedtime story in the offer.

 

"

• The trial population includes people with multiple long-term conditions, a population which often experiences a high disease and treatment burden and unmet health need."

So lots of all types of anything conditions mixed together (somehow meaningfully) and then let's burden them some more with the moralistic need to 'exercise' more 'cos that'll meet their health needs more...... As if

If it wasn't so repetitive, nauseating and boring it would be laughable. For some this is clearly ridiculous and harmful moralising

It's the endless pirouetting of the virtue of exercise that just goes on and on.... Soaking up limited research resources for ideas that might actually help people get their lives back in real world objective sense.

OK, I get that some mild stretching and strengthening exercises gently done can be of benefit to many, with and without health conditions and diseases, but do we need this being studied again and again?

 

"

• The primary outcome is feasibility and a range of participant outcomes will be assessed using a comprehensive range of questionnaires and endpoints."
  

Here are they:

https://photos.app.goo.gl/oDWB1oqLMoMdd9Gm8

Looking largely subjective questionnaires with three brief, objective physical tests that may or may not be meaningful Same old

 

And very weird choice that they always choose to go with subjective, having decided that any answer is no-win for disabled person except for their body magically becoming undisabled.

I'm starting to see through all of these things as just hands out for funding on the gravy-train. they aren't 'trials' at all.


The thing is the mis-thinking in their post-hoc justification of bigotry (I've started to sadly see it is quite stark that for most it just begins with a human nature horrible natural instinct of disliking disability) goes like this:

If you look at the population those who are least ill or disabled [say they] exercise more than those who aren't.

Non-ill person: I go to the gym/run to 'get fitter'

Maybe I just need to suggest to the ill person have they tried doing a little run 'because it might make them feel better' - they need this advice because they obviously don't, being disabled, so mightn't have experienced the wonderful benefits of how it makes you feel better.

Ill person: "thanks, I used to be an athlete so love exercise, but realised quickly it was making me worse" or "this is what happens when I exercise because I have x, y, z and all these things to contend with"

Non-ill person in old days under different culture/odd decent person now: I didn't realise that. Interesting additional information I have now added to my knowledge

Intervening culture: there is noone who doesn't benefit from exercise. Disabled people have a motivation issue.

And when their bodies actually react as they said they would and don't get more well now we can say it was their minds doing that. Plus of course they are stupider than us/are just a bit more 'conscious' of the 'little pains' that we all just 'get on with and ignore' so are probably doing it wrong. Now we can weaponise the term 'mental health' to get away with the term 'we think its a mental issue' and pretending 'it's because we care' rather than are attacking their right to reality being acknowledged.

Non-ill person now: I'd better not get involved and leave it 'to the experts' because I've been told we might hurt your mental health and health if I encourage you and I don't know what to believe. Your word and testimony is therefore worth a different amount to mine. And AKA 'the experts' have labelled you as 'don't touch or listen to them too much' under the guise of 'caring about you'. I (thinking I'm 'being a nice empathetic person' rather than psychologising) imagine it is hard being disabled and not being able to do all the fun things I get to do, it must be frustrating and I imagine it could get you down. Thanks for telling me how they feel and what it is like for them, that makes sense. Yes 'a vicious cycle'. You are right I'd better not talk to them... because it's a no, no for 'mental stuff'... I'll just 'try and be positive' with ideas of fun things.


Heck pointing out this observation has been given a misogyny/pseudopsychologising label so that even when we point this out as a no-win (then get called names like 'of course not that is being negative') before, and then they do it anyway exactly as predicted, it gets interpeted as 'being mental' (I'm bored of them pretending they are saying 'mental health' when that just dirties the term they are weaponising, at least they could be upfront in them selling 'hysterical woman all caused by their minds, if they were just a bit more positive about what we plan to do to them they'd be fine').


All this naffness has just hardened my resolve that eg ME Association and others were wrong in their thinking that they should pick their battles with not going up against CBT in the guideline. NOONE understands what CBT means, and that 'CBT' is a delivery mechanism so can be used as a trojan horse by changing what is meant (even though the 'no model on false beliefs or deconditioning' is the actual guideline) by it even being in there. It is being used to undermine even the GET stuff by others astoundingly getting away with suggesting 'sort their mind, and then GET will work' as if that was the problem with GET.

Being able to embed any old nonsense into treatment programmes is being enabled by there being a mere mention they can misinterpret because the area has been made an ambiguous mess they let non-qualified people into who don't scientifically assess whether 'what is being delivered' is 'the right thing' instead of 'delivered effectively' because they aren't psychologists. And because the biopsychosocial model isn't psychology so doesn't require anything to have a proper modelling where they link it back to 'cause' to show why it makes sense.

 

EDITED to add: indeed. But, a bit worrying, as others have mentioned that the bit they are testing is just the 'feasibility and acceptability' of the programme.

So rather than not spotting the issue is that the treatment doesn't work if the improvements aren't long rather than short term - which would be the case if not doing these things were the cause of the underlying health - they already think they are the cause and will help.

The real issue is, I suspect they think, how you get the people to 'stick at it' (because in their mind, obviously all this is what is needed). I think this partly plays into the propaganda that many people think there are lots who might be ill/staying ill/more ill than they need to be because they aren't acting right.

I'm not sure the next stage won't be some horrible long-term idea of how you get them to keep at it based on the assumption if they were they would be more well (a right circular one)?


Another start would be a law/rule that required them to be up front when writing said questionnaires about the exact claims they are actually going to use the data for. And what will be applied for/done on the basis of it.

Because coercion and social pressure tend to be the two tools at play and I suspect a lot of people are given the impression that it is 'more about whether that nice lady was trying hard to do a good job'

and have no clue that being polite and 'giving her a point to make her feel better' is leading to it being used to claim their condition is caused by not doing enough crochet.

 

yes, good point. Especially in a world where politicians answer questions about rising rates of long-term ill health with "clearly their benefits are too generous."

 

It's ironic that this trial is about "personalised" interventions but all the participants get the same advice, while a genuinely personalised offer of help would look at individual things that might make a serious difference to someone's health and QoL, like 'do you need care support or home adaptations that you can't get because your local council is bankrupt'.

Reminds me a bit of going to antenatal classes and baby groups that were all about this sort of micromanaging of minor tweaks, whereas actually we know what factors really affect babies' life chances in a measurable way, and they're things that no health visitor can change, which is why they distract themselves and us with the micromanagement instead.

 

This is what grieves me so much about the waste.

Care for chronically ill people needs reorganising from the ground up, to recognise that significant improvements to people's lives are possible if you stop spending money on pretending to do what you can't, and start spending it instead on doing what you can.

The obstacle seems to be that you'd have to ask people what they need, and believe what they say.

 

Besides the obvious fact that those who get the treatment will say they feel better than those who got bupkis. And it seems this one is another Crawley-type "feasibility-trial-transformed-into-full-trial." What is that gonna look like?

 

That'll likely look exactly like all the other poorly designed, inadequately measured (absence of the objective and real world measures) trials of last few decades. Going nowhere

'Old wine, new bottles' I believe was how Wessely put it

Almost gives the impression that this is all breathtakingly novel. Spangly new. No one has been here before. Must start again and again and again and again.... Could not possibly believe than 'no one' could possibly have thought of this before

And that no patients ever had thought to give a bit of gentle exercise on their own a try etc.... 'cos exercise is clearly the remedy for all ills (sarcasm off).

 

They're performative trials

Sometimes Orwellian ways breach the 4th wall and give you a peak behind the scenes. But we already had that several times, and no one is ever going to beat the GASLIGHT model.

And really this entire way of doing things is just performance, they are performing the act of doing trials, but the trials themselves are entirely irrelevant. It's just the production. Kind of like practicing how to produce movies, hire people, build sets, cast actors, have the tools and technology for post-production, but the movies never get released, they simply swap it for an old movie with a similar scenario, and it simply gets canned for tax credits, then the the whole team moves on to make another movie that never gets released.

So those teams know all about producing movies, how to raise money, how to spend it, how to organize teams, how to capture it all on film and so on, all the movements and rituals involved. But no one involved cares about the actual film, everyone is content with re-releasing the same movie hundreds of times over because the money keeps flowing to them anyway.

 

They seemed to have forgotten the big house in beautiful countryside and taking the waters. Alternatively willl bathing huts also be provided?

 

I expect the likes of me will still be balancing on one leg, trying to struggle out of a wet costume behind the undersized towel my mam's holding up.