Status:
UNKNOWN
Exercise-related Post-exertional Malaise
Lead Sponsor:
Stony Brook University
Conditions:
Chronic Fatigue Syndrome
Eligibility:
All Genders
18-65 years
Brief Summary
This pilot study is intended to identify sex differences in myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS) during recovery from brief but high effort exercise tests. It is expected that ...
Detailed Description
This supplement to the parent study, Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS): Activity patterns and autonomic function, is intended to enhance the larger home-based study with a f...
Eligibility Criteria
Inclusion
- patients aged 18-65 of both sexes who are considered physically capable of doing and blood pressure monitors (10 min/day) and an actigraph (16 days; waking hours only).
- subjects must meet validated phone-screen eligibility for CFS which will also require the symptom of post-exertional malaise. Also 3 out of 7 secondary symptoms of ME/CFS are required i.e., headaches, tender lymph nodes, sore throat, myalgias, arthralgias, sleep disturbance, and/or problems with memory or concentration.
Exclusion
- Cases of fatigue clearly attributable to self-report medical conditions such as untreated hypothyroidism, unstable diabetes mellitus, organ failure, chronic infections, and chronic inflammatory diseases, or AIDS.
- psychiatric disorders include any psychosis, or alcohol/ substance abuse within two years prior to illness onset and any time afterward, and current or past depression with melancholic or psychotic features within 5 years prior to onset of ME/CFS or anytime afterward.
- patients on heart medication or patients not dose-stabilized for at least 3 months on antidepressant drugs
- patients at significant risk of suicide or in need of urgent psychiatric treatment.
Key Trial Info
Start Date :
November 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03331419
Start Date
November 1 2017
End Date
October 1 2018
Last Update
November 6 2017
Active Locations (1)
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1
Stony Brook University
Stony Brook, New York, United States, 11794-8101