Clinical trial NCT02970240: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myalgic Encephalomyelitis
Chronic Fatigue Syndrome
Keywords: cardiopulmonary exercise testing
inflammation
oxidative status
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: The Glittre Clinic
name: Oslo University Hospital
First posted: 2016-11-21
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Patients with ME/CFS
2. Patients with fatigue but not ME/CFS
3. Healthy controls

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.

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

Primary outcomes:
measure: Maximal oxygen uptake
timeFrame: At 48 hour
Secondary outcomes:
measure: Lactate accumulation
timeFrame: At 48 hour
measure: Cytokine profile
timeFrame: At 48 hour
measure: Immunophenotyping
timeFrame: At 48 hour
measure: Cardiac status
timeFrame: At 48 hour
Other outcomes:
Locations:
city: Hakadal
country: Norway
facility: Glittre Clinic
Study officials:
affiliation: University of Oslo
name: Per O Iversen, MD
role: PRINCIPAL_INVESTIGATOR
References: