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Completed

NCT Number: NCT02970240

Cardiopulmonary Testing in ME/CFS to Improve Diagnostic Accuracy

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.

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Key information

Conditions

Myalgic Encephalomyelitis Chronic Disease Chronic Fatigue Syndrome Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Inflammation Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Glittre Clinic

Hakadal, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiopulmonary testing

Procedure

A 2-day consecutive testing on an ergometer cycle

Primary outcomes

  1. Maximal oxygen uptake

    Time frame: At 48 hour

    Measurement of oxygen uptake during ergometer cycling

Secondary outcomes

  1. Lactate accumulation

    Time frame: At 48 hour

    Regular sampling of blood for measurements of lactate

  2. Cytokine profile

    Time frame: At 48 hour

    Regular sampling of blood for measurements of cytokines

  3. Immunophenotyping

    Time frame: At 48 hour

    Regular sampling of blood for measurements of cell surface markers

  4. Cardiac status

    Time frame: At 48 hour

    Measurements of Cardiac function using ecco-cardiography

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Oslo University Hospital
  • The Glittre Clinic

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Nov 21, 2016
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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