The Clinical Core will recruit and screen subjects with ME/CFS and healthy sedentary controls.
An application for human subjects participation has been submitted to the Institutional Review Board and is under review.
There will be three locations where subjects will be able to participate in the study:
- New York City
- Los Angeles
- Ithaca, NY
Information concerning how to volunteer for participation as a subject in our studies will be provided on this site after our protocols are approved.
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The Clinical Core is co-directed by Dr. Betsy Keller, Ph.D., who has extensive experience in cardiopulmonary exercise testing (CPET) of ME/CFS patients and Dr. Geoff Moore, an internist with a special interest in the effect of exercise in health and chronic disease. ME/CFS expert physicians Susan Levine and John Chia will participate in evaluation of subjects and interpretation of medical tests. CPET will occur at Weill Cornell Medicine (with the assistance of Evelyn Horn, M.D., Cardiology), at the Ithaca College Wellness Clinic, and in Los Angeles (by the Workwell Foundation).
A hallmark symptom of ME/CFS is post-exertional malaise (PEM), or the exacerbation of a patient’s symptom complex following exertion beyond their unique threshold. The Clinical Core will obtain physiological data to establish the functional status of both patients and controls using the two-CPET protocol to assess the effects of PEM on functional capacity.
The increase of ME/CFS symptoms by a standardized exercise stressor provides researchers with a unique opportunity to evaluate the effects of PEM on a patient’s ability to produce energy to do work. This requires two sequential exercise stressors using CPET to first measure baseline functional capacity (maximum energy production) and a second test 24 hours later to measure the effects of exertion on energy production. Biological samples obtained from subjects will be used to identify changes in the physiological and molecular responses to exercise that occur in ME/CFS in comparison to healthy sedentary controls
The Clinical Core will oversee testing of patients and controls at three different sites in two states (New York, California), which differ in demographics and environmental factors. Subjects will be located in two urban but distinctly different environments (greater New York City and Los Angeles) and in the rural areas of central and Western New York State.