(Recruiting) Exercise Intolerance in Post-COVID Patients, 2022, Lundberg et al

[FMMM1]

You could contact the Swedish Covid Association info@covidforeningen.se, and suggest they do it? Or RME info@rme.nu?

Contacted researcher* and groups you identified - anyone know a long covid group - preferably in Sweden?

*"
Andrea,
re study on "Exercise Intolerance in Post-COVID Patients" - the study description states "The overall goals of this project are to ---- 3) provide knowledge that can be directly applied in the clinical setting to improve diagnosis, care, and individualized rehabilitation of subjects with post-COVID syndrome" & "It is hypothesized that the mechanism responsible for exercise intolerance is linked to specific symptoms and will vary across subjects. However, it is expected that most post-COVID subjects will respond well to at least one type of exercise."
https://clinicaltrials.gov/ct2/show/NCT05445830

You're probably aware that the assessment of outcomes has been very controversial in ME/CFS. NICE found that the majority of studies were "low or very low" quality. [Page 317 - NICE Evidence Review for new Guideline on ME/CFS -https://www.nice.org.uk/guidance/ng206/documents/evidence-review-7]. I.e. these studies did not provide useful data to interpret interventions such as exercise. Typically studies were unblinded and used subjective outcome criteria i.e. questionnaires. All unblinded studies require objective outcome assessment e.g. Actimetry (FitBIIT type devices).

Objectively measuring activity, pre and post intervention, using Actimetry, will increase confidence in assessing whether the intervention worked.

An example of a study which used Actimetry is the Rituximab study by Fluge & Mella - Note

Yours sincerely,
-----

Note - "Materials and methods: In this pilot study, 27 patients with mild to severe ME/CFS, of mean age 42.3 years, used the Fitbit Charge 3 continuously for six months. Patients wore a SenseWear activity bracelet for 7 days at baseline, at 3 and 6 months. At baseline and follow-up they completed the Short Form 36 Health Survey (SF-36) and the DePaul Symptom Questionnaire-Short Form (DSQ-SF)."
https://pubmed.ncbi.nlm.nih.gov/36121803/

 

[mango]

Contacted researcher* and groups you identified

Great, thank you

anyone know a log covid group - preferably in Sweden?

The Swedish Covid Association is the only organisation, as far as I'm aware, that is doing this kind of long covid advocacy/activism work in Sweden.

(There are several Swedish long covid Facebook groups as well, but as far as I know none of them are into organised advocacy/activism work.)

There's a Norwegian Covid Association as well, but I don't know much about them. They are pretty new, I believe? The Swedish Covid Association calls them their "sister organisation".

 

[FMMM1]

Great, thank you

The Swedish Covid Association is the only organisation, as far as I'm aware, that is doing this kind of long covid advocacy/activism work in Sweden.

(There are several Swedish long covid Facebook groups as well, but as far as I know none of them are into organised advocacy/activism work.)

There's a Norwegian Covid Association as well, but I don't know much about them. They are pretty new, I believe? The Swedish Covid Association calls them their "sister organisation".

I've only skimmed the study but the researchers basically need to establish the baseline (pre-intervention), and then the post intervention baseline, i.e. with a high degree of confidence. Otherwise there's a danger they will claim improvement:

• when the activity levels of participants haven't improved - day to day living/ability to perform normal tasks; and/or
• when the activity levels of participants haven't improved relative to the control group.

I think the Norwegian, Fluge & Mella, study used longer term monitoring i.e. to establish the baseline pre/post intervention - day to day living/ability to perform normal tasks. This study appears to use much shorter assessment - does that reflect actual improvement in activity levels?

 

[Amw66]

I wonder if @longcovidphysio on twitter are aware of this ?

 

[Medfeb]

I wonder if @longcovidphysio on twitter are aware of this ?

Great idea.

I wonder what the authors mean by "submaximal exercise response (CPET)."

The 2-day CPET studies typically use the respiratory exchange ratio (RER) as part of determining when to stop the exercise. RER is the point at which the body is producing energy anaerobically as shown by measures of gas exchange. Reportedly, once the body hits the RER, a person can't continue for very long. This is the same for both patients and controls and I understood it to mean the person had reached his max effort and that patients could reach that before they reached the max heart rate for their age.

So are they using that and calling it submax or are they going for a specific amount of time?

On another note, they report matching on age and sex. But ideally, they'd also match on the level of sedentariness. Fitbit monitoring is one way trials have done it.

 

[Medfeb]

I doubt that this study explicitly says "we will be asking you to over-exert via CPET, and you may therefore experience harm", so to my mind the patients taking part can't possibly have given informed consent. Of course the counter argument is that we have no definitive proof that over-exertion causes harm, but then NICE, and others, have changed their treatment guidelines based on the patient survey reports of harms.

Good point. And the inclusion and exclusion criteria of the study do not mention consideration of PEM/PESE. So they could have a mixed cohort of people who experience PEM and people who don't. Could complicate study interpretation on their primary and other outcome measures

 

[Mij]

There is a difference in symptoms between PVFS and M.E PEM, it can develop into M.E later down the road based on my own experiences.

It would be helpful to understand the pathophysiology of post-infectious syndromes, but not at the expense of patients who are ill and can become worse

 

[FMMM1]

I've only skimmed the study but the researchers basically need to establish the baseline (pre-intervention), and then the post intervention baseline, i.e. with a high degree of confidence. Otherwise there's a danger they will claim improvement:

• when the activity levels of participants haven't improved - day to day living/ability to perform normal tasks; and/or
• when the activity levels of participants haven't improved relative to the control group.

I think the Norwegian, Fluge & Mella, study used longer term monitoring i.e. to establish the baseline pre/post intervention - day to day living/ability to perform normal tasks. This study appears to use much shorter assessment - does that reflect actual improvement in activity levels?

I emailed the above to the Swedish Covid-19 Association - info@covidforeningen.se
and cc to:
kontakt@covidforeningen.no - Norwegian Covid-19 Association
info@rme.nu - Swedish ME Association
tommy.lundberg@ki.se & andrea.tryfonos@ki.se - researchers - contacts for the trial - https://clinicaltrials.gov/ct2/show/NCT05445830

 

[Amw66]