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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04026425
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : July 22, 2020
Sponsor:
Collaborators:
Cornell University
Weill Cornell Medicine
Workwell Foundation
Information provided by (Responsible Party):
Ithaca College

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myalgic Encephalomyelitis Chronic Fatigue Syndrome Other: Two-day cardiopulmonary exercise test Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Probing Metabolism, Circulating Inflammatory Molecules, Extracellular Vesicles and Immune Dysregulation in Individual Immune Cells in ME/CFS
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ME/CFS
Adults with ME/CFS
 Other: Two-day cardiopulmonary exercise test
A series of two cardiopulmonary exercise tests (CPETs) performed over two days. Participants will perform a CPET and then will return approximately 24 hours later to perform the second CPET. The CPET begins with 3 minutes of seated rest followed by cycling during incremental workloads which increases 15 watts throughout each minute of exercise. The participant will cycle until volitional exhaustion and/or the participant and/or test administrator determines to stop the test. Actual exercise time usually varies between 8-10 minutes.
Active Comparator: Healthy controls
Healthy, low-active adults
 Other: Two-day cardiopulmonary exercise test
A series of two cardiopulmonary exercise tests (CPETs) performed over two days. Participants will perform a CPET and then will return approximately 24 hours later to perform the second CPET. The CPET begins with 3 minutes of seated rest followed by cycling during incremental workloads which increases 15 watts throughout each minute of exercise. The participant will cycle until volitional exhaustion and/or the participant and/or test administrator determines to stop the test. Actual exercise time usually varies between 8-10 minutes.


Outcome Measures
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Primary Outcome Measures :
  1. Volume of oxygen consumed at peak effort [ Time Frame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date. ]
    Volume of oxygen consumed at peak effort during CPET 1 and during CPET 2.

  2. Volume of oxygen consumed at ventilatory/anaerobic threshold (VAT) [ Time Frame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date. ]
    VAT is a non-invasive surrogate measure for anaerobic threshold, which is indicated during incremental exercise by a non-linear increase in rate of carbon dioxide production relative to rate of oxygen consumption.

  3. Rate of work performed at peak effort [ Time Frame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date. ]
    Rate of work performed at peak effort during CPET 1 and during CPET 2. Rate of work is measured in Watts.

  4. Rate of work performed at VAT [ Time Frame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date. ]
    Rate of work performed at VAT during CPET 1 and during CPET 2. Rate of work is measured in Watts.

  5. Heart rate at peak effort [ Time Frame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date. ]
    Heart rate at peak effort during CPET 1 and during CPET 2.

  6. Heart rate at VAT [ Time Frame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date. ]
    Heart rate at VAT during CPET 1 and during CPET 2.

  7. Systolic blood pressure at seated rest [ Time Frame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date. ]
    Systolic blood pressure at seated rest 1-minute before the start of CPET 1 and 1-minute before the start of CPET 2.

  8. Systolic blood pressure at peak effort [ Time Frame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date. ]
    Systolic blood pressure at peak effort during CPET 1 and during CPET 2.

  9. Respiratory Exchange Ratio (RER) at peak effort [ Time Frame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date. ]
    RER at peak effort during CPET 1 and during CPET 2. RER is calculated as the rate of carbon dioxide production divided by the rate of oxygen consumption, and during exercise is an indicator of participant effort.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04026425


Locations
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United States, California
ID Med Recruiting
Torrance, California, United States, 90505
Contact: Jared Stevens, B.S.    209-599-7194    info@workwellfoundation.org   
United States, New York
Ithaca College Active, not recruiting
Ithaca, New York, United States, 14850
Weill Cornell Medicine Recruiting
New York, New York, United States, 10021
Contact: Xiangling Mao, M.S.    212-746-2632    xim2004@med.cornell.edu   
Sponsors and Collaborators
Ithaca College
Cornell University
Weill Cornell Medicine
Workwell Foundation
Investigators
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Study Director: Betsy Keller, Ph.D. Ithaca College
Study Director: Geoff Moore, M.D. Ithaca College
More Information
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Additional Information:

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Responsible Party: Ithaca College
ClinicalTrials.gov Identifier: NCT04026425    
Other Study ID Numbers: U54NS105541 ( U.S. NIH Grant/Contract )
5U54NS105541 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ithaca College:
cardiopulmonary exercise test (CPET)
post-exertional malaise (PEM)
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Encephalomyelitis
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
 Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Central Nervous System Infections