Cardiopulmonary Testing in ME/CFS to Improve Diagnostic Accuracy

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Brief Title

Cardiopulmonary Testing in ME/CFS to Improve Diagnostic Accuracy

Official Title

Cardiopulmonary Exercise Testing as a Diagnostic Tool and a Quantitative Measure of Post-exertional Malaise in Myalgic Encephalopathy/Chronic Fatigue Syndrome

Brief Summary

      Circumstantial evidence suggests that patients diagnosed with myalgic encephalopathy/chronic
      fatigue syndrome (ME/CFS) perform worse on day 2 in a 2-day consecutive cardiopulmonary
      exercise test (CPET). The aim of this study is to examine if CPET can distinguish between
      ME/CFS patients and healthy controls.
    

Detailed Description

      Myalgic encephalopathy/chronic fatigue syndrome (ME/CFS) leads to a substantial reduction in
      activity level. Cardiopulmonary exercise testing (CPET) quantifies physical performance, or
      functional capacity, by direct measurements of the maximal oxygen uptake (VO2max). Functional
      capacity is the ability of an individual to perform aerobic work as defined by the VO2max,
      and the assessment of functional capacity reflects the ability to perform activities of daily
      living that require sustained aerobic metabolism.

      To the best of knowledge few robustly designed studies on repeated CPET in ME/CFS are
      published, and they demonstrated a significant reduction in functional capacity expressed as
      VO2max and anaerobic threshold. This marked functional decline on the second test has
      apparently not been described for any other chronic, disabling conditions, and might
      represent a possible diagnostic tool for ME/CFS; hence the investigators will examine this.
      In addition they will examine other biological markers (e.g. cytokines and anti-oxidative
      compounds) before and after the exercise tests to test if the groups can be further
      distinguished.

      The main aim of this study is to evaluate the use of repeated CPET as an objective diagnostic
      marker of ME/CFS. Specifically the investigators want to address the following questions:

      I. Will patients with ME/CFS demonstrate a significant reduction in VO2max compared to
      healthy individuals? If such a difference can be demonstrated, is it unique for patients with
      ME/CFS classified according to the strictest criteria compared to others with longstanding
      fatigue?

      II. What is the blood lactate profile before, during and after CPET?

      III. Are there any correlations between the decline in VO2max and other biological variables
      such as markers of oxidative stress, immune dysregulation or metabolic dysfunction?

      IV. Is cardiac function impaired among ME/CFS patients as assessed by ecco-cardiography?

      Three groups will be included: (i) ME/CFS patients; (ii) patients with fatigue, but not
      MF/CFS; and (iii) healthy controls.
    


Study Type

Observational


Primary Outcome

Maximal oxygen uptake

Secondary Outcome

 Lactate accumulation

Condition

Myalgic Encephalomyelitis

Intervention

Cardiopulmonary testing

Study Arms / Comparison Groups

 ME/CFS group
Description:  Patients with a verified diagnosis of ME/CFS according to the Canada criteria

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

90

Start Date

June 2014

Completion Date

December 2020

Primary Completion Date

April 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosed with ME/CFS according to the Canadian and Fukuda criteria; miid to
             moderately affected)

          -  Provide written consent

          -  Able to perform the test

        Exclusion Criteria:

          -  Not provided written consent

          -  Unable to perform the test
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Per O Iversen, MD, , 

Location Countries

Norway

Location Countries

Norway

Administrative Informations


NCT ID

NCT02970240

Organization ID

2012/571


Responsible Party

Principal Investigator

Study Sponsor

University of Oslo

Collaborators

 The Glittre Clinic

Study Sponsor

Per O Iversen, MD, Principal Investigator, University of Oslo


Verification Date

April 2019