Clinical trial NCT04026425: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myalgic Encephalomyelitis
Chronic Fatigue Syndrome
Keywords: cardiopulmonary exercise test (CPET)
post-exertional malaise (PEM)
Lead sponsor: Ithaca College
Sponsor class: OTHER
Collaborators: name: Cornell University
name: Weill Medical College of Cornell University
name: Workwell Foundation
First posted: 2019-07-19
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Volume of oxygen consumed at peak effort
timeFrame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
measure: Volume of oxygen consumed at ventilatory/anaerobic threshold (VAT)
timeFrame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
measure: Rate of work performed at peak effort
timeFrame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
measure: Rate of work performed at VAT
timeFrame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
measure: Heart rate at peak effort
timeFrame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
measure: Heart rate at VAT
timeFrame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
measure: Systolic blood pressure at seated rest
timeFrame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
measure: Systolic blood pressure at peak effort
timeFrame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
measure: Respiratory Exchange Ratio (RER) at peak effort
timeFrame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Secondary outcomes:
Other outcomes:
Locations:
city: Torrance
country: United States
facility: ID Med
state: California
city: Ithaca
country: United States
facility: Ithaca College
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Ithaca College
name: Betsy Keller, Ph.D.
role: STUDY_DIRECTOR
affiliation: Ithaca College
name: Geoff Moore, M.D.
role: STUDY_DIRECTOR
References: