Analysis of Post-exertional Malaise Using a Two-day CPET in People With ME/CFS

  • STATUS
    Recruiting
  • End date
    Aug 31, 2022
  • participants needed
    180
  • sponsor
    Ithaca College
Updated on 25 February 2021
exercise stress test
malaise
cardiopulmonary exercise testing

Summary

This study aims to collect and identify key outcome measures or disease parameters in ME/CFS that are altered during elevated symptoms relative to baseline by gathering information before and after symptom provocation using a two-day cardiopulmonary exercise test.

Description

The phenomenon of post-exertional malaise (PEM), in which an ME/CFS patient's symptoms are elevated following even low-level exertion, is a hallmark feature of the disease. The cause of PEM, like the cause of ME/CFS, is not understood. This study aims to utilize a two-day CPET to invoke PEM. This provides a unique opportunity to collect data on how key outcome measures or disease parameters are altered during elevated symptoms relative to baseline within each patient by gathering information before and after symptom provocation.

A total of 90 participants and 90 controls will undergo CPET testing. Participation will be split amongst three different sites (Ithaca, NY, New York, NY, and Los Angeles, CA). Subjects will be located in urban and rural areas to establish relatively diverse study populations.

This study is a component of the Cornell ME/CFS Collaborative Research Center (CRC). Blood samples taken before and after CPET will be utilized in associated projects with the Cornell ME/CFS CRC. CPET data along with the analysis of blood samples has great potential to reveal why exercise negatively affects ME/CFS patients and thus perhaps why patients are also impaired even before increasing their activity level.

Details
Condition Chronic Fatigue Syndrome, Viral infection, Viral Infections
Treatment Two-day cardiopulmonary exercise test
Clinical Study IdentifierNCT04026425
SponsorIthaca College
Last Modified on25 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have any of these conditions: Viral Infections or Chronic Fatigue Syndrome or Viral infection?
Do you have any of these conditions: Chronic Fatigue Syndrome or Viral Infections or Viral infection?
Do you have any of these conditions: Chronic Fatigue Syndrome or Viral infection or Viral Infections?
Do you have any of these conditions: Viral Infections or Viral infection or Chronic Fatigue Syndrome?
Healthy
Low-active
Adults 18 to 70 years of age

Exclusion Criteria

Recent history of panic attacks within the past 6 months
Diagnosis of schizophrenia, major depressive disorder, bipolar disorder, or an anxiety disorder such as OCD or PTSD
Hospitalized for a psychological condition within the last 6 months
Unwilling to stop taking nutritional supplements, including probiotics, two weeks before the exercise tests
Unwilling to stop pain medication and stimulant medication two days before the exercise tests
Smoker, or stopped smoking less than 1 year ago
Pregnant or breastfeeding
Diabetic
Have an orthopedic limitation that prohibits cycle exercise
Excessive alcohol consumption
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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