Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
Conditions
Brief summary
The purpose of this study is to examine cardiopulmonary function in Chronic Fatigue Syndrome (CFS) patients and determine how it relates to the common symptom of Post-exertional malaise (PEM). Subjects will complete a maximal exercise test on 2 subsequent days. Total blood volume will be measured prior to each exercise test, and patient with hypovolemia on day 1, will be randomized to either a saline or sham infusion prior to the 2nd exercise test. A total of 80 CFS patients will be enrolled.
Interventions
PROCEDURESaline Infusion
Patient with hypovolemia on day 1 will be randomized to a saline or sham infusion prior to the Day 2 exercise test.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 25 to 60 * Meet the 2015 IOM case definition for ME/CFS
Exclusion criteria
* Patients with a medical cause for their fatigue * Patients taking medications that would dampen cardiac response to exercise * Patients with psychotic illness, bipolar disorder, or current major depressive disorder * Patients with a history of anorexia or bulimia within 5 years of intake * Patients with a history of alcohol or drug abuse within 2 years of intake
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CPET testing | 2 days | To assess VO2VT and peak VO2 |
| Total Blood Volume | 2 days | To measure Total Blood Volume (TBV) before each exercise test |
| Hypovolemia | 1 day | Patients with reduced Total Blood Volume on day #1 CPET will be randomized in a 1:1 fashion to either a one hour infusion of a liter of isotonic saline prior to day #2 CPET or a sham infusion |
Countries
United States
Outcome results
None listed