USA 2026: Trial of Pacing and Graded Exercise

T

Thomas4

New Member
Hello everyone,

I am involved in a research study examining two commonly discussed activity-management approaches for people with CFS/ME: Pacing Therapy and Graded Exercise Therapy.

We're looking for adults ages 18–65 who have a diagnosis of CFS/ME (or meet common diagnostic criteria) and have had relatively stable symptoms for at least three months.

Participants would take part in a 4 week exercise program consisting of roughly 3 short sessions a week. Participants will complete questionnaires about fatigue and physical functioning, maintain brief weekly symptom logs, and participate in brief online biweekly check-ins through surveys.

The goal is to better understand participant experiences, adherence, and outcomes associated with these approaches.

Moderator note: We have removed the contact form and contact email since they do not appear to have any official standing.
 
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How are yu going to justify this study on ethical grounds @Thomas4, when
1. trials to date indicate that exercise programmes do not help and are associated with reports of significant worsening.
2. It does not look as if you are going to be conducting a study that will be able to provide any further information on efficacy.

In that light, studying the experiences, adherence and outcomes associated with an exercise programme seems straightforwardly unethical. (I say this as a physician who spent several years sitting on an ethics committee.)
 
Please can you link to the registered protocol for this clinical trial, including the name of the principal researcher and the ethics approval.

You should be aware that graded exercise therapy has been tested multiple times already, has never been shown to be effective, and has a high rate of causing harm. I would urge you and your colleagues to withdraw this trial.
 
Thomas4 said:
Hello everyone,

I am involved in a research study examining two commonly discussed activity-management approaches for people with CFS/ME: Pacing Therapy and Graded Exercise Therapy.

We're looking for adults ages 18–65 who have a diagnosis of CFS/ME (or meet common diagnostic criteria) and have had relatively stable symptoms for at least three months.

Participants would take part in a 4 week exercise program consisting of roughly 3 short sessions a week. Participants will complete questionnaires about fatigue and physical functioning, maintain brief weekly symptom logs, and participate in brief online biweekly check-ins through surveys.

The goal is to better understand participant experiences, adherence, and outcomes associated with these approaches.
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Dear Thomas

This is an international website with members across the world.

Here in the UK, we do not use the term CFS or CFS/ME, in fact it is offensive.

Here in the UK we have the National Institute for Clinical Excellence which advises on treatment. Graded Exercise is specified “should not be offered” You may like to review the research behind the decision which shows why GET and exercise is contraindicated for people with ME/CFS https://www.nice.org.uk/guidance/ng206/evidence/d-identifying-and-diagnosing-mecfs-pdf-9265183025

In the UK you would not pass the ethics to do such a study, your university wouldn’t approve it.
 
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@Thomas4

Are you aware of the FITNET-NHS trial and MAGENTA?

They found no evidence of benefit and upwards of 25 % experienced deterioration.

In the recent trial of inpatient rehabilitation tailored to ME/CFS specifically, almost half experienced a reduced Bell score.

Other studies have found no benefit on objectively measured outcomes like step count, and the changes in the subjective outcomes have been fully in the range of what’s expected from bias along when not blinding the intervention.

If we ignore the whole host of ethical issues with using exercise in relation to ME/CFS, how are you going to ensure that the data you gather would even be reliable enough to be included in a future evidence review? As I hope you are aware of, NICE discarded every single behavioural trial up to that point because they were too poorly done. Why would your trial not be discarded as well on the same grounds?

And are you going to inform the participants of the findings in the trials I’ve mentioned? Surely you would need to do that in order for the consent to be informed.
 
My sincere thanks to everyone responding in this thread. It is beyond me why researchers are still not giving up on the exercise approach. Different ways of pacing, maybe, but exercise programmes? I genuinely find it very offensive and ignorant. I don't know how else to say it
 
Hi @Thomas4, I hope you will understand my skepticism about whether this is a real and feasible trial. It is important that any study recruiting for participants gives the names of the investigators and the institution, and notes which ethics committee has approved it.

There are numerous issues, beyond the obvious one already mentioned that graded exercise has been trialled extensively already and found by independent evaluators to have no value. 'Pacing' is extremely difficult to study, because most people with ME/CFS are pacing in some form or another (i.e. reducing their activity levels) by 6 months after onset, simply because life is impossible if they do not.

Another issue is that recruiting online creates all sorts of biases. You cannot easily confirm the claimed diagnosis, you cannot easily confirm compliance. And, importantly, with a therapy that carries significant risk of physical deterioration and psychological harm, you cannot easily monitor and take care of the participants. I think obtaining insurance against participant harm would be extremely difficult.

With everything done via online surveys, how could you possibly know that a number of your participants are not actually people with ME/CFS, but are people who just want to make graded exercise therapy seem to be useful? Your study will have no credibility.

Another issue is that you have given no indication of followup, following the 4 week exercise programme. We know that many people with ME/CFS could complete the training programme and might even provide positive feedback at that point. However, they may already be deteriorating, and, certainly, if they continue to try to exercise, while not reducing activity in some other aspect of their life, some will deteriorate over time. It is essential that any intervention aiming to increase activity has a followup period of many months.
 
Thomas4 said:
I am involved in a research study examining two commonly discussed activity-management approaches for people with CFS/ME: Pacing Therapy and Graded Exercise Therapy.
Click to expand...

In addition to the points others have made, it would also be worth understanding that neither of the things you call therapies are therapies.

Pacing is an approach used by patients to avoid worsening. So-called graded exercise therapy is a long discredited approach invented by a group of psycho behaviourists, whose output suggests they thought themselves exempt from all the boring evidential stuff expected of people developing real therapies. It does not need repeating, so please don't.
 
Thomas4 said:
Participants would take part in a 4 week exercise program consisting of roughly 3 short sessions a week. Participants will complete questionnaires about fatigue and physical functioning, maintain brief weekly symptom logs, and participate in brief online biweekly check-ins through surveys.
Click to expand...

Please do not say this is yet another study failing to included objective outcomes such as electronic activity monitoring. Such trials are necessarily unblinded, meaning that subjective outcomes make any results almost impossible to interpret.

There are potential trials around possible benefits from different activity management approaches and increasingly electronic activity monitoring is effectively being used in other fields which could be developed into protocols the patient community could be able to support. However, given Post Exertional Malaise (PEM) is the defining symptom of ME/CFS, any study that looks to direct increasing activity should now be an automatic no no.

Also even if such a study could be attempted without risking harm, only those with mild or moderate impairment could attempt to participate. This seems yet another study that attempts to address a condition by ignoring the most severe. We have decades of wasted research into this condition, that perhaps might have been avoided had researchers bother to develop approaches relevant to the condition as a whole, rather than those least impacted.
 
@Thomas4

In short, both your underlying hypothesis and methodology stink. They have been flogged to death by the psycho-behavioural-rehab club for literally decades in hundreds of studies, and have never delivered an unambiguous and clinically meaningful (and safe) benefit. If anything the collective evidence from them shows the contrary.

No amount of tweaking the dose, or fine tuning the explanation to patients, is going to suddenly make this approach work. The science and history on this clear. It is dead and buried by all fair robust standards. Or at least it should have been no later then 15 years ago.

This is just another waste of our lives and the extremely limited and precious research resources available to this grossly underfunded field. It is way past time to look elsewhere for answers.

I do appreciate your interest in this condition, and hope you can go on to do some good work on it. But this really ain't the way to do it.

Please do a serious rethink of your proposal.
 
@Thomas4, I should have said in my earlier post, welcome to the forum. We do encourage researchers to participate so it is good that you are here.

Unfortunately researchers seeking such participation at the recruitment stage may find it is not the most effective time to take advantage of the collective patient, carer, advocate and researcher expertise we can offer.

It relation to this it would be interesting to know what patient participation was used in the development of this research and what involvement patients will have in its ongoing oversight.
 
Coming back to this with a few further thoughts and questions.

Is this trial being run by health professionals at a university, if so, which one, what is their specialism, and what is their experience of clinical care for people with ME/CFS? Is it a student project?

What preliminary literature search led the research team to think their trial would be any different from the dozens of preceding trials?

Were any patients or patient organisations consulted or involved in the trial design?

Why no objective outcome measures? How long after will follow up data be collected? How will you ensure the exercise is within each patients PEM threshold on each exercise day?

What health benefits do you expect the exercise to achieve when by definition ME/CFS must include PEM which limits patients activity capacity?

Are you aware of how seriously ill people with ME/CFS become if they repeatedly push past their exertion limits triggering PEM?

The more I think about this trial, the more horrified i am. To put it bluntly, it appears the researchers either have no understanding of ME/CFS, or are deliberately setting out to cause harm.

I have to assume it's not the latter, so i am left assuming appalling ignorance. That can be fixed if the researchers are open minded, prepared to listen and learn, and have the good sense to realise they have made a serious blunder, and cancel the trial.
 
Hi @Thomas4 and welcome. Have a look at these fact sheets - they'll help explain why this research is ill-conceived.

Science For ME

Post in thread 'Science for ME Fact Sheets'

Fact Sheet 1: Introduction to ME/CFS
Published March 2025
Link to pdf: Introduction to ME/CFS - S4ME-Factsheet.pdf
Link to pdf of French translation: Introduction_à_l_EMSCF-S4ME-Feuille_information

Discussion thread: Fact sheet #1- Introduction to ME/CFS March 2025 Discussion

Introduction to ME/CFS

Key points
  • ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome) is an illness that has a substantial, often severe impact on people's lives and is usually long-term.

  • It affects about 1 in 250 people, including children...
  • Like
 
Hello @Thomas4, welcome to the forum.

Thomas4 said:
Participants would take part in a 4 week exercise program consisting of roughly 3 short sessions a week.
Click to expand...
Could you explain more about the nature of the exercise programme? What does it consist of?

We're looking for adults ages 18–65 who have a diagnosis of CFS/ME (or meet common diagnostic criteria) and have had relatively stable symptoms for at least three months.
Click to expand...
Could you explain more about the bolded part? Does this mean that people with diagnoses other than ME/CFS will be participating in the trial?
 
Thomas4 said:
Hello everyone,

I am involved in a research study examining two commonly discussed activity-management approaches for people with CFS/ME: Pacing Therapy and Graded Exercise Therapy.

We're looking for adults ages 18–65 who have a diagnosis of CFS/ME (or meet common diagnostic criteria) and have had relatively stable symptoms for at least three months.

Participants would take part in a 4 week exercise program consisting of roughly 3 short sessions a week. Participants will complete questionnaires about fatigue and physical functioning, maintain brief weekly symptom logs, and participate in brief online biweekly check-ins through surveys.

The goal is to better understand participant experiences, adherence, and outcomes associated with these approaches.

Moderator note: We have removed the contact form and contact email since they do not appear to have any official standing.
Click to expand...
is this a windup?
Haven't you heard of the PACE trial?
 
Braganca said:
Interesting that people studying these “ideas” always choose to name our disease incorrectly.

When you see “CFS/ME”, you can assume the next sentence will include “exercise”.
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I was about to make a similar comment. Strong red flag the study proposal originates out of the BPS stable somewhere. Quite shocked to read the original post in this thread, though sanity had finally won through in this regard. Sadly not it seems.

Did the US medical establishment ever pick up on the UK's 2021 NG206 NICE Guideline for ME/CFS, and amend there own health guidelines similarly? If so then this proposed US trial should hopefully progress no further.
 
Thomas4 said:
Hello everyone,

I am involved in a research study examining two commonly discussed activity-management approaches for people with CFS/ME: Pacing Therapy and Graded Exercise Therapy.

We're looking for adults ages 18–65 who have a diagnosis of CFS/ME (or meet common diagnostic criteria) and have had relatively stable symptoms for at least three months.

Participants would take part in a 4 week exercise program consisting of roughly 3 short sessions a week. Participants will complete questionnaires about fatigue and physical functioning, maintain brief weekly symptom logs, and participate in brief online biweekly check-ins through surveys.

The goal is to better understand participant experiences, adherence, and outcomes associated with these approaches.

Moderator note: We have removed the contact form and contact email since they do not appear to have any official standing.
Click to expand...

Astonished you think to entertain such a study, let alone canvas for volunteers here. Suggest you read this, for starters:-

NICE Guideline NG206

NG206 - Do not offer GET to people with ME/CFS

1783770710948.webp

But DO please advise what the research is that you are engaged in regarding GET and Pacing Therapy.
 
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Barry said:
Did the US medical establishment ever pick up on the UK's 2021 NG206 NICE Guideline for ME/CFS, and amend there own health guidelines similarly?
Click to expand...
The CDC removed Graded exercise therapy and CBT from its website in 2017
meassociation.org.uk

CDC removes CBT and GET as recommended treatments for ME/CFS | 11 July 2017 - The ME Association

In America, the Centers for Disease Control and Prevention (CDC) […]
meassociation.org.uk meassociation.org.uk

eta: https://undark.org/2017/07/26/cdc-chronic-fatigue-graded-exercise/

it was after the IOM report in 2015
 
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