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Open Stanford (Montoya) study “Exercise and Immune Profiling in ME/CFS”

Discussion in 'Recruitment into current ME/CFS research studies' started by Webdog, Feb 13, 2019.

  1. Webdog

    Webdog Senior Member (Voting Rights)

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    I verified with Stanford that it was ok to share with other patients. This Montoya study is on exercise, the human microbiome and ME/CFS, and includes a bicycle exercise tolerance test.

    ----
    Over the past year, there has been growing interest in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
 around the world. An increasing number of scientists and clinicians are engaging in research and practices that have the potential to lead to a greater understanding of the root causes of ME/CFS. I am excited to report that Dr. Jose Montoya’s Stanford ME/CFS Initiative will be joining in a new collaborative research effort with Columbia University to further understand the association between exercise, the human microbiome and ME/CFS.

    We are inviting you to participate in a new study entitled “Exercise and Immune Profiling in ME/CFS”. In this study, we will ask you to participate in a baseline screening assessment in our clinic (Location: Stanford University). We will ask you to provide in-depth information about your symptoms and medical conditions in the form of questionnaires, and to undergo a brief physical exam and blood collection; At this time, our team will provide kits for the collection of stool and saliva samples for the next phase of the study, and we will schedule your appointment for a bicycle exercise tolerance test (ETT).

    In the next phase, you will be asked to complete two study visits, immediately before and 24-hours after administration of an ETT (Location: Stanford Hospital). You will bring your collected samples (stool and saliva for research purposes) with you, and will undergo blood collections at both visits. You will complete a series of questionnaires at each visit, and at three time points in between.

    All procedures conducted under this research study will be free of charge.

    Upon completion of each study assessment, sample collection and self-report questionnaires, you will receive reimbursement in a staged fashion. Therefore, you will receive $25 for the pre-ETT visit 2, $50 for the ETT visit and $50 for the post-ETT visit.

    If you are interested in participating in this study, please complete the following eligibility survey (Prescreening for ME/CFS Exercise Tolerance Testing Study). If you are not interested in the study or do not wish to participate, please do not be concerned. Your decision will in no way affect the clinical care that you receive at Stanford Hospital & Clinics. If you would like to get in touch with the Clinical Research Coordinator, Tullia Lieb, please email tlieb@stanford.edu

    Participant’s rights questions, contact 1-866-680-2906

    Sincerely,
    Jose Montoya, M.D.
     
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  2. wigglethemouse

    wigglethemouse Senior Member (Voting Rights)

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    You would have thought they would put a description of the bicycle exercise tolerance test (ETT) in the letter, or the link to the questionnaire. Most folks with ME are going to be concerned about the crash following the test and will want to know more details about what the test entails. Perhaps you can feed that back to them @Webdog
     
  3. Webdog

    Webdog Senior Member (Voting Rights)

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    Good points. I'd suggest directing questions to the email in the letter. As I understand it, Stanford is recruiting patients, but is still working on study procedures.
     
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  4. wigglethemouse

    wigglethemouse Senior Member (Voting Rights)

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    I took up your suggestion @Webdog and here is Tullia's explanation

    ---------------------------------
    The purpose of this study is to evaluate the immune system and microbiome of ME/CFS patients before and then during a post exertional malaise episode. PEM is one of the hallmark symptoms of ME/CFS and there has not been a ton of work done trying to figure out what exactly is going on.
    The exercise test that we are using is able to evaluate cardiovascular function and how well your body is able to use oxygen.
    Here's a brief description of the test: https://med.virginia.edu/exercise-p...ment-for-community-members-2/vo2-max-testing/

    We understand that exercise is difficult for most, if not all ME/CFS patients, and we do not advise patients to participate without first weighing the pros and cons to their health. We are happy to speak with patients individually to help assess their participation.
    [​IMG]
    VO2 Max Testing - UVA

    The Exercise Physiology Core lab is pleased to offer the fitness and body composition services listed below to members of the community. These are precise measurements of fitness levels, as opposed to indirect or estimated measures that are available elsewhere.
    med.virginia.edu

    I did the test myself, and my experience was around ten minutes long, but you can stop whenever you feel like you cannot keep up with the pace.

    I hope this answers some of your questions. Let me know.

    P.S. we do not condone graded exercise therapy as a treatment for CFS. If anything, we try to encourage patients to minimize the number of PEM episodes they have.

    Tullia Lieb
    Clinical Research Coordinator
    T: (650)-723-8126
    email: tlieb@stanford.edu
     
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  5. wigglethemouse

    wigglethemouse Senior Member (Voting Rights)

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    Some extra clarification from Stanford
    1) The bicycle challenge is only on one day. The second day, patients come in for a blood draw.
    2) The cardiologist is willing to write up a short report with the VO2 max for the patient who participates.
     
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  6. Milo

    Milo Senior Member (Voting Rights)

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    I would be curious to know whether microbiome composition would change in the subsequent days following the exercise rather than only 24 hours after. My rationale is that some people will not have any bowel movement 24 hours especially if they are travelling for this test as travel and stress can change bowel habits.

    Then I wonder whether colonies (is that the right term?) or composition of the microbiome changes according to where the stool is located, whether it is in the colon or in the small bowel at the time of exercise and collection, and whether this changes in the several hours amd days following the exercise test.

    That would be an interesting study.

    Lastly, the amount awarded to the patient is minimal, and sadly i am reminded of a certain researcher who was conducting psychological studies that were rewarding 600$ per patient. I really wish patients were awarded substantial amount of money to submit to an exercise test that will set them back for weeks or months.

    This said I am not adverse to the study, in fact I welcome it.
     
    Last edited: Feb 15, 2019
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  7. Ron

    Ron Established Member (Voting Rights)

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    I just finished up doing this study a few days ago and am still crashed and have been in bed most of the last few days. It will be all worth it if this helps get us closer to understanding and a cure. The staff at Stanford is very helpful and friendly in making it the least intrusive as possible.
     
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  8. rvallee

    rvallee Senior Member (Voting Rights)

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    Hopefully you recover quickly, it's a hard choice to make as we never know what could be the tipping point towards a new permanent low, but sacrificing bodies has basically been the only way progress was made in this disease, whether for research or advocacy.

    Every straw on the camel's back feels too light to make a difference, but it all adds up.
     
  9. Little Bluestem

    Little Bluestem Senior Member (Voting Rights)

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    @Ron, thank-you so much for taking part in this study. :emoji_cake: :emoji_tea: :hug:
     
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  10. roller*

    roller* Senior Member (Voting Rights)

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    @Ron, have you been in a crash when one of the stool samples was taken ?
    if so, how much of the crash you were in by then (in %... in case it got worse after taking sample)

    did they also take other things, blood, urine ?

    and the test was just bicycle ?
     
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  11. Ron

    Ron Established Member (Voting Rights)

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    I was in the "crash" mode on the second stool sample. I can't give an accurate assessment of percentage. I definitely have gotten worse over the course of the following
    couple of days. Yes, they took blood before the exercise challenge and 24 hours after. Also I had to deliver saliva samples before and after plus numerous questionnaires
    before and after. Yes, the testing was just on a bike.
    I felt so good during the bike ride. I even told the doc, "You guys better figure this out as I don't want to wait another fifteen years to ride a bike again".
     
    Last edited by a moderator: May 4, 2019
  12. wigglethemouse

    wigglethemouse Senior Member (Voting Rights)

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    Hi @Ron. I'm wondering how long did it take you to recover and did you receive a report from the Cardiologist? If you got a report do you think the report would be good enough to show loss of function for disability purposes? Having that sort of evidence for no cost might attract more recruits to the study.
     
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  13. Ron

    Ron Established Member (Voting Rights)

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    Hi @wigglethemouse '

    It took me over a week to recover. I did receive a report from the Cardiologist which I posted part of below.


    Cardiopulmonary Exercise Testing
    Exercise performed: 10 watt Ramp protocol on upright ergo cycle
    Exercise time: 12 minutes, 26 seconds


    Parameter----------------Resting----------------Peak Exercise---------------Units

    HR (bpm)--------------------- 81-------------------------156------------------------- Beats per minute

    Blood Pressure -------------171/91------------------ 210/100----------------------- mmHg

    Oxygen Saturation----------100------------------------ 99 ---------------------------- %

    VO2 ------------------------- 3.9 ------------------------19.8------------------------- ml/kg/min
     
  14. Webdog

    Webdog Senior Member (Voting Rights)

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    Interesting. I didn’t get a report from the cardiologist, but would certainly be interested to see one.

    Following the bicycle exercise, it took about 60 hours for a full PEM crash. 60 hours was beyond what the study recorded, unfortunately.

    Recovery to baseline following the bicycle exercise took 2 months.
     
  15. Ron

    Ron Established Member (Voting Rights)

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    Hi @Webdog ,

    You should follow up by email and ask again. I had to ask a couple times before receiving mine.
    Thanks for taking part in this trial as it wasn't easy.
     
  16. Webdog

    Webdog Senior Member (Voting Rights)

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    Good suggestion. Thanks. :)
     
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