Open Analysis of Post-exertional Malaise Using a Two-day CPET in People With ME/CFS, 2021, Ithaca College

John Mac

John Mac

Senior Member (Voting Rights)
This study aims to collect and identify key outcome measures or disease parameters in ME/CFS that are altered during elevated symptoms relative to baseline by gathering information before and after symptom provocation using a two-day cardiopulmonary exercise test.

Description
The phenomenon of post-exertional malaise (PEM), in which an ME/CFS patient's symptoms are elevated following even low-level exertion, is a hallmark feature of the disease. The cause of PEM, like the cause of ME/CFS, is not understood. This study aims to utilize a two-day CPET to invoke PEM. This provides a unique opportunity to collect data on how key outcome measures or disease parameters are altered during elevated symptoms relative to baseline within each patient by gathering information before and after symptom provocation.

A total of 90 participants and 90 controls will undergo CPET testing.
Participation will be split amongst three different sites (Ithaca, NY, New York, NY, and Los Angeles, CA).
Subjects will be located in urban and rural areas to establish relatively diverse study populations.

This study is a component of the Cornell ME/CFS Collaborative Research Center (CRC). Blood samples taken before and after CPET will be utilized in associated projects with the Cornell ME/CFS CRC. CPET data along with the analysis of blood samples has great potential to reveal why exercise negatively affects ME/CFS patients and thus perhaps why patients are also impaired even before increasing their activity level.

Details
Condition Chronic Fatigue Syndrome, Viral infection, Viral Infections
Treatment Two-day cardiopulmonary exercise test
Clinical Study Identifier NCT04026425
Sponsor Ithaca College
Last Modified on 21 February 2021
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https://www.centerwatch.com/clinica...us=50&query=chronic-fatigue-syndrome&smt=true
 
This study came up on PR, and my comment was that researchers should look into using cognitive triggers for PEM. Maybe socializing for 10 minutes will produce the same level of PEM, but with less harm to the patient. It would also avoid extraneous factors resulting from the physical exertion. Trigger PEM both ways in the same individual and see what is the same and what's different.
 
Creekside said:
This study came up on PR, and my comment was that researchers should look into using cognitive triggers for PEM. Maybe socializing for 10 minutes will produce the same level of PEM, but with less harm to the patient. It would also avoid extraneous factors resulting from the physical exertion. Trigger PEM both ways in the same individual and see what is the same and what's different.
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Not every ME patient gets PEM from cognitive exertion. (Though most PwME I know, do get PEM from cognitive exertion.) I suspect that measuring cognitive exertion is not as convincing (visible) as physical exertion and might be more open to
 
Denise said:
Not every ME patient gets PEM from cognitive exertion.
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Not every PWME gets PEM from physical exertion either, or even gets it to the same degree from the same exertion. I could hike or bike for hours without triggering PEM, yet climbing a ladder once would trigger it. I expect that a lot (most?) of us have both triggers to some degree (although I no longer get physically-induced PEM). Developing methods for using both triggers would expand the toolbox for experiments with PEM. There will probably be situations where one or the other is superior, and using results from both offers yet more opportunity for useful results.

Denise said:
I suspect that measuring cognitive exertion is not as convincing (visible) as physical exertion
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Conservatism is a problem. Running PWME on a treadmill is accepted practice; engaging them in a conversation isn't, and it admittedly is harder to quantify. However, developing a reliable method for cognitive triggering of PEM might make that research group look good. :)
 
I lost about 15% of my function from doing the 2 day cpet. I emailed Dr. Hanson to let her know this. I do believe most people who do the test recover to their baseline, but some don’t. I think the risks are much too high for studies like this.

edit: just realized this is not a new study. It’s been running since 2019, and they’ve already done most of the patients.
 
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cassava7 said:
Dr Maureen Hanson presented the preliminary results of this study at the CDC stakeholder call/webinar in September 2020 (slides 29 to 39): https://www.cdc.gov/me-cfs/pdfs/Hanson-CDC-talk-092020-508.pdf (transcript, audio)
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The earlier slides are a recap of recently published studies (discussed elsewhere on the forum).

The slides showing the preliminary results from 2-day CPET exercise provocation studies currently underway are interesting (the transcript related to these starts at page 15).

They're looking at how exercise affects the cargo (cytokines as well as other proteins) carried by extracellular vesicles and are finding significant differences.

Plus they're looking at plasma metabolites before and after exercise and finding significant differences here, too. What was interesting is that for general metabolites the differences between patients and controls increased at each of the 4 time points (pre- & post-CPET1 plus pre- & post-CPET2). That makes intuitive sense, we just get worse and worse.

More surprising was that when they looked specifically at the number of lipid species and fatty acids they found they were a little higher in ME than in controls but fairly stable over the first 3 time points. But then after the second CPET there suddenly were very significantly more lipid species and fatty acids in ME than in controls.

The significance of any of these findings remains to be established (assuming the differences remain after more people are tested).
 
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