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

Ithaca College

Status: Completed

Conditions: Myalgic Encephalomyelitis; Chronic Fatigue Syndrome

Treatments: Other: Two-day cardiopulmonary exercise test

Study type: Interventional

Funder types: Other

Identifiers

NCT04026425

5U54NS105541 (U.S. NIH Grant/Contract)

U54NS105541

Details and patient eligibility

About

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.

Full 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.

Enrollment: 173 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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173 participants in 2 patient groups

ME/CFS

Experimental group

Description:

Adults with ME/CFS

Treatment:

Other: Two-day cardiopulmonary exercise test

Healthy controls

Active Comparator group

Description:

Healthy, low-active adults

Treatment:

Other: Two-day cardiopulmonary exercise test