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Cardiopulmonary Testing in ME/CFS to Improve Diagnostic Accuracy

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ClinicalTrials.gov Identifier: NCT02970240
Recruitment Status : Active, not recruiting
First Posted : November 21, 2016
Last Update Posted : April 5, 2019
Sponsor:
Collaborators:
The Glittre Clinic
Oslo University Hospital
Information provided by (Responsible Party):
Per Ole Iversen, MD, University of Oslo

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.

Condition or disease Intervention/treatment
Myalgic Encephalomyelitis Chronic Fatigue Syndrome Procedure: Cardiopulmonary testing

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.


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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Cardiopulmonary Exercise Testing as a Diagnostic Tool and a Quantitative Measure of Post-exertional Malaise in Myalgic Encephalopathy/Chronic Fatigue Syndrome
Actual Study Start Date : June 2014
Actual Primary Completion Date : April 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ME/CFS group
Patients with a verified diagnosis of ME/CFS according to the Canada criteria
Procedure: Cardiopulmonary testing
A 2-day consecutive testing on an ergometer cycle

Fatigue group
Patients with fatigue, but not ME/CFS
Procedure: Cardiopulmonary testing
A 2-day consecutive testing on an ergometer cycle

Control group
Healthy control persons
Procedure: Cardiopulmonary testing
A 2-day consecutive testing on an ergometer cycle




Primary Outcome Measures :
  1. Maximal oxygen uptake [ Time Frame: At 48 hour ]
    Measurement of oxygen uptake during ergometer cycling


Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  1. Patients with ME/CFS
  2. Patients with fatigue but not ME/CFS
  3. Healthy controls
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970240


Locations
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Norway
Glittre Clinic
Hakadal, Norway
Sponsors and Collaborators
University of Oslo
The Glittre Clinic
Oslo University Hospital
Investigators
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Principal Investigator: Per O Iversen, MD University of Oslo

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Responsible Party: Per Ole Iversen, MD, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT02970240     History of Changes
Other Study ID Numbers: 2012/571
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Per Ole Iversen, MD, University of Oslo:
cardiopulmonary exercise testing
inflammation
oxidative status
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Syndrome
Fatigue
Myalgia
Encephalomyelitis
Disease
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Central Nervous System Infections
Musculoskeletal Pain
Pain
Neurologic Manifestations