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

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Brief Title

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

Official Title

Probing Metabolism, Circulating Inflammatory Molecules, Extracellular Vesicles and Immune Dysregulation in Individual Immune Cells in ME/CFS

Brief 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.
    

Detailed 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.
    


Study Type

Interventional


Primary Outcome

Volume of oxygen consumed at peak effort


Condition

Myalgic Encephalomyelitis

Intervention

Two-day cardiopulmonary exercise test

Study Arms / Comparison Groups

 ME/CFS
Description:  Adults with ME/CFS

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

180

Start Date

August 1, 2018

Completion Date

August 31, 2022

Primary Completion Date

August 31, 2020

Eligibility Criteria

        Adults with ME/CFS:

        Inclusion Criteria:

          -  Diagnosed with ME/CFS

          -  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

        Healthy Volunteers:

        Inclusion Criteria:

          -  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
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Betsy Keller, Ph.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04026425

Organization ID

U54NS105541

Secondary IDs

5U54NS105541

Responsible Party

Sponsor

Study Sponsor

Ithaca College

Collaborators

 Cornell University

Study Sponsor

Betsy Keller, Ph.D., Study Director, Ithaca College


Verification Date

July 2020