COMPLETED

Cardiovascular Analysis of PEM

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Cardiovascular Analysis of Post-exertional Malaise

Quick Facts

Study Start:2021-08-31
Study Completion:2025-07-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04740736

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages 25 to 60
  2. * Meet the 2015 IOM case definition for ME/CFS
  1. * Patients with a medical cause for their fatigue
  2. * Patients taking medications that would dampen cardiac response to exercise
  3. * Patients with psychotic illness, bipolar disorder, or current major depressive disorder
  4. * Patients with a history of anorexia or bulimia within 5 years of intake
  5. * Patients with a history of alcohol or drug abuse within 2 years of intake

Contacts and Locations

Principal Investigator

Benjamin Natelson, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Benjamin Natelson, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

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

Study Start Date2021-08-31
Study Completion Date2025-07-11

Study Record Updates

Study Start Date2021-08-31
Study Completion Date2025-07-11

Terms related to this study

Additional Relevant MeSH Terms

  • Myalgic Encephalomyelitis
  • Chronic Fatigue Syndrome