The 12th Invest in ME Conference, Part 1
OverTheHills presents the first article in a series of three about the recent 12th Invest In ME international Conference (IIMEC12) in London.
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(Stony Brook University, USA) Exercise-related Post-exertional Malaise (CFS/ME)

Discussion in 'Active Clinical Studies' started by Dolphin, Feb 12, 2018.

  1. Dolphin

    Dolphin Senior Member


    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


    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
    Contact: Fred Friedberg, PhD
    Location: Stony Brook University, Stony Brook, New York, United States, 11794-8101
    Gemini and duncan like this.
  2. duncan

    duncan Senior Member

    Why would a psych want to try to, potentially, highlight and "assess biobehavioral sex" differences between men and women with ME/CFS?

    If anyone feels there may be a benefit in distinguishing disease characteristics by gender,why not simply attempt to assess potential biological differences? What's with the behavioral component?

    Whenever I see a psych use the word "functional", I am compelled to ask for clarification...
  3. *GG*

    *GG* senior member

    Concord, NH
    Who is behind this Website? It doesn't seem to be functional to me, I signed up, but am not able to log in.

  4. rel8ted


  5. rel8ted


    Just FYI, this clinical trial does appear to focus on autonomic dysfunction, but this is whose idea the study was Fred Friedberg, PhD, Associate Professor of Psychiatry at Stony Brook University School of Medicine.

    This study will involve patients self-reporting their symptoms and activities on a weekly online diary over a period of six months. Data will also be recorded from mobile heart devices and activity monitors that the patients wear at home. Over the six month study period, patients will regularly send this objective data back to the Stony Brook laboratory where the information will be downloaded and analyzed for patterns related to CFS symptoms, activities, and impairments.
    The participants will then be interviewed by a psychiatric nurse via phone about other potentially important illness factors including major life events they have experienced over the study period, their physical and social functioning, and changes in their illness status – i.e., improved or worsened.


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