An observational study in Myalgic Encephalomyelitis and Chronic Fatigue Syndrome, sponsored by University of Oslo. Completed at 1 site in Norway. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-04.
Sponsored by University of Oslo · Observational
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.
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.
263 studies on the registry are indexed under Fatigue Syndrome, Chronic; 61 are open to participants now.
This study's enrollment of 33 is below the median of 150 across 77 observational studies indexed under Fatigue Syndrome, Chronic.
Browse Fatigue Syndrome, Chronic studies →University of Oslo is the lead sponsor of 177 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
Patients with a verified diagnosis of ME/CFS according to the Canada criteria
Procedure: Cardiopulmonary testing
Patients with fatigue, but not ME/CFS
Procedure: Cardiopulmonary testing
Healthy control persons
Procedure: Cardiopulmonary testing
A 2-day consecutive testing on an ergometer cycle
Maximal oxygen uptake
Measurement of oxygen uptake during ergometer cycling
Time frame: At 48 hour
Lactate accumulation
Regular sampling of blood for measurements of lactate
Time frame: At 48 hour
Cytokine profile
Regular sampling of blood for measurements of cytokines
Time frame: At 48 hour
Immunophenotyping
Regular sampling of blood for measurements of cell surface markers
Time frame: At 48 hour
Cardiac status
Measurements of Cardiac function using ecco-cardiography
Time frame: At 48 hour
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2014 to primary completion in Apr 2019, 58 months.
Of 39 non-industry observational studies under Fatigue Syndrome, Chronic, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 79. This study's 58 months is above that.
Counting every sponsor, half of 41 studies reached it within 44 months; a quarter within 25 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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