Cardiovascular Analysis of PEM
Purpose
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.
Conditions
- Myalgic Encephalomyelitis
- Chronic Fatigue Syndrome
Eligibility
- Eligible Ages
- Between 25 Years and 60 Years
- Eligible Genders
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Saline Infusion |
|
|
|
Sham Comparator Sham Infusion |
|
Recruiting Locations
Icahn School of Medicine at Mount Sinai
New York, New York 10029
New York, New York 10029
More Details
- NCT ID
- NCT04740736
- Status
- Recruiting
- Sponsor
- Icahn School of Medicine at Mount Sinai