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Cardiovascular Analysis of PEM
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
🗓️ Study Start (Actual) 31 August 2021
🗓️ Primary Completion (Estimated) 28 February 2025
✅ Study Completion (Estimated) 28 February 2025
👥 Enrollment (Estimated) 47
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 25 Years to 60 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 February 2021
  • First Submitted that Met QC Criteria 2 February 2021
  • First Posted 5 February 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 February 2024
  • Last Update Posted 26 February 2024
  • Last Verified February 2024
I'm interested ...!!