Myalgic EncephalomyelitisNCT02970240
Cardiopulmonary Testing in ME/CFS to Improve Diagnostic Accuracy
An observational study of Myalgic Encephalomyelitis and Chronic Fatigue Syndrome, run by University of Oslo at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myalgic Encephalomyelitis, Chronic Fatigue Syndrome
- What is being tested?
- Cardiopulmonary testing
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2014to Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Patients with ME/CFS 2. Patients with fatigue but not ME/CFS 3. Healthy controls
Who may be able to join
- Diagnosed with ME/CFS according to the Canadian and Fukuda criteria; miid to moderately affected)
- Provide written consent
- Able to perform the test
Who cannot join
- Not provided written consent
- Unable to perform the test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiopulmonary Exercise Testing as a Diagnostic Tool and a Quantitative Measure of Post-exertional Malaise in Myalgic Encephalopathy/Chronic Fatigue Syndrome
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.
Read the 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:
- 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.
- Being tested
- Cardiopulmonary testing
- Keywords
- cardiopulmonary exercise testing, inflammation, oxidative status
- Medical subject headings
- Fatigue Syndrome, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary testingProcedure or surgery
A 2-day consecutive testing on an ergometer cycle
| Study group | Role | What they receive |
|---|---|---|
| ME/CFS group | Patients with a verified diagnosis of ME/CFS according to the Canada criteria Receives: Procedure: Cardiopulmonary testing | |
| Fatigue group | Patients with fatigue, but not ME/CFS Receives: Procedure: Cardiopulmonary testing | |
| Control group | Healthy control persons Receives: Procedure: Cardiopulmonary testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen uptake
Measurement of oxygen uptake during ergometer cycling
Measured: At 48 hour
Secondary outcomes (4)
Lactate accumulation
Regular sampling of blood for measurements of lactate
Measured: At 48 hour
Cytokine profile
Regular sampling of blood for measurements of cytokines
Measured: At 48 hour
Immunophenotyping
Regular sampling of blood for measurements of cell surface markers
Measured: At 48 hour
Cardiac status
Measurements of Cardiac function using ecco-cardiography
Measured: At 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startJun 2014
- Primary completionApr 2019
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myalgic EncephalomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- The Glittre Clinic, Oslo University Hospital
- Responsible party
- Principal investigator, Per Ole Iversen, MD, University of Oslo
- Investigators
- Per O Iversen, MD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970240
- Sponsor's protocol ID
- 2012/571
- Status last verified
- Nov 2020
- First submitted
- 14 Nov 2016
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Exercise Testing as a Diagnostic Tool and a Quantitative Measure of Post-exertional Malaise in Myalgic Encephalopathy/Chronic Fatigue Syndrome
- ClinicalTrials.gov ID
- NCT02970240
- Acronym / sponsor ID
- 2012/571
- Keywords
- cardiopulmonary exercise testing, inflammation, oxidative status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- The Glittre Clinic, Oslo University Hospital
- Study start
- Jun 2014 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ME/CFS group | – | Procedure: Cardiopulmonary testingPatients with a verified diagnosis of ME/CFS according to the Canada criteria |
| Fatigue group | – | Procedure: Cardiopulmonary testingPatients with fatigue, but not ME/CFS |
| Control group | – | Procedure: Cardiopulmonary testingHealthy control persons |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients with ME/CFS 2. Patients with fatigue but not ME/CFS 3. Healthy controls
Key inclusion criteria (3 listed)
- Diagnosed with ME/CFS according to the Canadian and Fukuda criteria; miid to moderately affected)
- Provide written consent
- Able to perform the test
Key exclusion criteria (2 listed)
- Not provided written consent
- Unable to perform the test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary testingA 2-day consecutive testing on an ergometer cycle | Procedure or surgery | Control group, Fatigue group, ME/CFS group |
Primary outcome
Maximal oxygen uptake
Time frame: At 48 hour
Measurement of oxygen uptake during ergometer cycling
4 secondary outcomes
Lactate accumulation
Time frame: At 48 hour
Cytokine profile
Time frame: At 48 hour
Immunophenotyping
Time frame: At 48 hour
Cardiac status
Time frame: At 48 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per O Iversen, MD principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myalgic Encephalomyelitis and Chronic Fatigue Syndrome, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal oxygen uptake (time frame: At 48 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.