Participation of Human Subjects in NIH Center Research

There will be three locations where subjects will be able to participate in the study:

  • New York City (completed, not recruiting)
  • Los Angeles (completed, not recruiting)
  • Ithaca, NY (completed, not recruiting)

The three different sites in two states 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. All subjects will perform at CPET. In addition, at the New York City site, subjects will also undergo MRI and PET scans.

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Human subject participation will be coordinated by a Clinical Core 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. A patient’s baseline physiological condition can be examined by an initial cardiopulmonary exercise test (CPET), and PEM can be characterized by examining CPET data when the patient repeats the exercise challenge the following day.

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. By examining patients at baseline and after their symptoms increase, we hope to discover the molecular basis of PEM, one of the most disabling symptoms of ME/CFS.