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Recruiting study: (Stony Brook University, USA) Exercise-related Post-exertional Malaise (CFS/ME)

Discussion in 'BioMedical ME/CFS News' started by Dolphin, Feb 13, 2018.

  1. Dolphin

    Dolphin Senior Member (Voting Rights)

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    Brief Summary:


    This pilot study is intended to identify sex differences in myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS) during recovery from brief but high effort exercise tests. It is expected that women with ME/CFS as compared to males with ME/CFS will show slower recovery from exercise with respect to heart rate and blood pressure, physical functioning, and symptom severity. Also females with ME/CFS as compared to males with ME/CFS will show greater negative impacts on heart rate, blood pressure, physical functioning and symptom severity after the two exercise tests. The findings will have implications for sex differences in the pathophysiology of post-exertional malaise and activity/exercise self-management recommendations, given the expected detrimental effects of the brief intense exercise tests on patients with ME/CFS.


    Detailed Description:

    This supplement to the parent study, Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS): Activity patterns and autonomic function, is intended to enhance the larger home-based study with a face-to-face laboratory arm. Specifically, the investigators propose a pilot study to assess biobehavioral sex differences in ME/CFS during recovery after a brief high exertion exercise task, i.e., a six-minute walk test repeated on two consecutive days. The investigators expect adverse symptomatic, functional, and autonomic effects following this repeat exercise test. This "post-exertional malaise (PEM)" and its impact on global outcomes is a unique feature of ME/CFS that is being studied in the parent observational study conducted by participants entirely in their homes. In the proposed supplement, PEM and its impacts will be captured in real time under controlled conditions in the research team's laboratory. Of particular interest, autonomic effects of PEM on heart function and blood pressure using non-invasive research grade monitors. The specific aims are as follows:



    Specific Aim 1: After two high-effort six minute walk tests conducted on consecutive days, female subjects with ME/CFS as compared to male ME/CFS subjects will show slower recovery with respect to cardiovascular autonomic functioning, physical functioning, and symptom resolution. Specific Aim 2: Female subjects with ME/CFS as compared to males with ME/CFS will show greater adverse impact on autonomic and physical functioning and symptom severity after the day 2 exercise test.



    To more accurately characterize exercise recovery abnormalities differentiated by sex, the investigators propose to longitudinally monitor symptoms, activity levels, and autonomic status during the week before (baseline) as compared to the week after (follow-up) the two exercise tests. This pilot study will also provide potential cross-validation of the parent project which hypothesizes specific relationships between autonomic function symptom severity and activity limitations. A parallel analysis of sex differences will also be carried out on the data collected in the parent project.



    The pilot study will remain within the scope of the original aims of the parent study to identify bio-behavioral factors related to PEM, symptom-worsening activity patterns, and non-improvement in ME/CFS. This supplement will expand the parent project's home-based data collection to a controlled setting with direct observation and verification of exercise tests carried out by participants in the principal investigator's laboratory.



    Estimated Enrollment : 40 participants
    Official Title: Sex Differences in Exercise-related Post-exertional Malaise in ME/CFS



    Participants:

    Group 1: Males with Chronic Fatigue Syndrome
    Two brief high effort exercise tests on consecutive days in our laboratory in order to provoke abnormalities in ME/CFS patients with respect to autonomic function, symptom exacerbation, and activity limitations. (30 sec of knee squats followed by a six minute walk test repeated on consecutive days)



    Group 2: Females with Chronic Fatigue Syndrome

    Two brief high effort exercise tests on consecutive days in our laboratory in order to provoke abnormalities in ME/CFS patients with respect to autonomic function, symptom exacerbation, and activity limitations. (30 sec of knee squats followed by a six minute walk test repeated on consecutive days)



    Primary Outcome Measures :
    Heart rate variability [ Time Frame: 15 days ] The time and frequency variation in heart rate recorded on a portable heart monitor.



    Secondary Outcome Measures :

    • Six minute walk distance (m) [ Time Frame: 24 hours ] Distance walked on the six minute walk test
    • Blood pressure [ Time Frame: 24 hours ] Blood pressure taken before and after six minute walk tests
    • Physical activity [ Time Frame: 15 days ] The daily physical activity levels measured with an accelerometer
    • Online web diary [ Time Frame: 15 days ] Symptom intensities recorded on online web diary
    Inclusion Criteria:

    • Patients aged 18-65 of both sexes who are considered physically capable of doing and blood pressure monitors (10 min/day) and an actigraph (16 days; waking hours only).
    • Subjects must meet validated phone-screen eligibility for CFS which will also require the symptom of post-exertional malaise. Also 3 out of 7 secondary symptoms of ME/CFS are required i.e., headaches, tender lymph nodes, sore throat, myalgias, arthralgias, sleep disturbance, and/or problems with memory or concentration.
    Exclusion Criteria:

    • Cases of fatigue clearly attributable to self-report medical conditions such as untreated hypothyroidism, unstable diabetes mellitus, organ failure, chronic infections, and chronic inflammatory diseases, or AIDS.
    • Psychiatric disorders include any psychosis, or alcohol/ substance abuse within two years prior to illness onset and any time afterward, and current or past depression with melancholic or psychotic features within 5 years prior to onset of ME/CFS or anytime afterward.
    • Patients on heart medication or patients not dose-stabilized for at least 3 months on antidepressant drugs
    • Patients at significant risk of suicide or in need of urgent psychiatric treatment.
    Contact: Patricia Bruckenthal, PhD 631-444-3268 patricia.bruckenthal@stonybrook.edu
    Contact: Fred Friedberg, PhD fred.friedberg@stonybrookmedicine.edu
    Location: Stony Brook University, Stony Brook, New York, United States, 11794-8101
     
  2. Trish

    Trish Moderator Staff Member

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    Sounds like they will only be able to include very mildly affected patients able to attend the clinic on 2 consecutive days and do that amount of exercise each day. I hope it doesn't cause serious crashes for the participants.

    Given that Naviaux found gender differences in metabolomics, it sounds interesting, but I wish they would include taking blood samples so they could be tested - even if they just store them in a biobank for later testing when funding allows. If they are going to put patients at that level of risk of relapse, I'd hope they would make the effort and risk more worthwhile by learning as much as possible from the patients.

    And I'd like a healthy control group for each gender too...

    But I guess that's not the way studies work. They get a small amount of funding to do a focused study to test a specific hypothesis, and can't just extend it out in all directions to study other hypotheses at the same time.
     
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  3. Barry

    Barry Senior Member (Voting Rights)

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    The ethics approval for this might be interesting. On the once hand it could be an extremely informative pilot study. On the other hand it could inform that people can suffer severe worsening of their condition.
     
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  4. duncan

    duncan Senior Member (Voting Rights)

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    A psych looking into biobehavioral gender differences in pwME? What could go wrong?
     
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  5. Valentijn

    Valentijn Not a moderator

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    I'm not thrilled with the term "biobehavioral" either. It's basically BPS with more focus on the biomedical aspect, but still focused how behavior can (be changed to) impact health. I'm not sure why physiological results, with no behavioral intervention involved, are being described as biobehavioral. It suggests a primary attribution of those physiological results to behavior, which I'm not at all comfortable with.

    I could see a pacing or GET trial being described as biobehavioral, but it doesn't make sense to describe the response of ME patients to exercise as biobehavioral. Unless they think our behavior is influencing our disease somehow, such as with deconditioning, avoidant behaviors, etc.
     
    Last edited: Feb 13, 2018
    Samuel, EzzieD, inox and 8 others like this.
  6. dreampop

    dreampop Established Member (Voting Rights)

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    Edited out wrong info
     
    Last edited: Feb 15, 2018
  7. Valentijn

    Valentijn Not a moderator

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    Which project was that?

    Which study? This one involves adults.
     
  8. dreampop

    dreampop Established Member (Voting Rights)

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    Yeah, I don't know how I misread this proposal so badly and I confused the author with Ben Katz.
     
  9. Louie41

    Louie41 Senior Member (Voting Rights)

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    Samuel and Invisible Woman like this.
  10. MErmaid

    MErmaid Guest

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    http://www.stonybrook.edu/

    I love their motto!

    EMPOWERING UNDERFUNDED OVERACHIEVERS

    :emoji_microscope::emoji_microscope::emoji_microscope::emoji_microscope:

    I am wondering if we could modify this for ME...

    ME Advocacy! Empowering our Underfunded Scientific Overachievers!

    Or

    S4ME Advocacy! Empowering our Underfunded Scientific Overachievers!

    Or

    S4ME! Empowering our Underfunded Scientific Overachievers!
     

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