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Cardiopulmonary Testing in ME/CFS to Improve Diagnostic Accuracy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02970240
Enrollment
33
Registered
2016-11-21
Start date
2014-06-30
Completion date
2020-11-30
Last updated
2020-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myalgic Encephalomyelitis, Chronic Fatigue Syndrome

Keywords

cardiopulmonary exercise testing, inflammation, oxidative status

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.

Interventions

A 2-day consecutive testing on an ergometer cycle

Sponsors

The Glittre Clinic
CollaboratorUNKNOWN
Oslo University Hospital
CollaboratorOTHER
University of Oslo
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Maximal oxygen uptakeAt 48 hourMeasurement of oxygen uptake during ergometer cycling

Secondary

MeasureTime frameDescription
Lactate accumulationAt 48 hourRegular sampling of blood for measurements of lactate
Cytokine profileAt 48 hourRegular sampling of blood for measurements of cytokines
ImmunophenotypingAt 48 hourRegular sampling of blood for measurements of cell surface markers
Cardiac statusAt 48 hourMeasurements of Cardiac function using ecco-cardiography

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026