Participation of Human Subjects in NIH Center Research

There were three locations where subjects were 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 were 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 performed a CPET. In addition, at the New York City site, subjects underwent MRS and PET scans.

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Human subject participation was 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 participated in the evaluation of subjects and interpretation of medical tests. CPET occurred 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 participants have been banked at Cornell University and indexed into a database. These samples are being 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.

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