Status:
COMPLETED
Analysis of Post-exertional Malaise Using a Two-day CPET in People With ME/CFS
Lead Sponsor:
Ithaca College
Collaborating Sponsors:
Cornell University
Weill Medical College of Cornell University
Conditions:
Myalgic Encephalomyelitis
Chronic Fatigue Syndrome
Eligibility:
All Genders
18-70 years
Phase:
NA
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 sy...
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 ...
Eligibility Criteria
Inclusion
- Adults with ME/CFS:
- Diagnosed with ME/CFS
- Adults 18 to 70 years of age
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT04026425
Start Date
August 1 2018
End Date
March 31 2023
Last Update
July 7 2023
Active Locations (3)
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1
ID Med
Torrance, California, United States, 90505
2
Ithaca College
Ithaca, New York, United States, 14850
3
Weill Cornell Medicine
New York, New York, United States, 10021