Cardiopulmonary Testing in ME/CFS to Improve Diagnostic Accuracy

• Sponsor: University of Oslo (Other)
• Overall Status: Completed
• CT.gov ID: NCT02970240
• Collaborator: The Glittre Clinic (Other), Oslo University Hospital (Other)
• Enrollment: 33
• Location: 1
• Actual Duration (Months): 77
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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	Phase
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:

1. 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?

2. What is the blood lactate profile before, during and after CPET?

3. Are there any correlations between the decline in VO2max and other biological variables such as markers of oxidative stress, immune dysregulation or metabolic dysfunction?

4. 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

• Study Type: Observational
• Actual Enrollment: 33 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: Jun 1, 2014
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Nov 1, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Maximal oxygen uptake [At 48 hour]

   Measurement of oxygen uptake during ergometer cycling

Secondary Outcome Measures

1. Lactate accumulation [At 48 hour]

   Regular sampling of blood for measurements of lactate

2. Cytokine profile [At 48 hour]

   Regular sampling of blood for measurements of cytokines

3. Immunophenotyping [At 48 hour]

   Regular sampling of blood for measurements of cell surface markers

4. Cardiac status [At 48 hour]

   Measurements of Cardiac function using ecco-cardiography

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Glittre Clinic	Hakadal		Norway

Sponsors and Collaborators

• University of Oslo
• The Glittre Clinic
• Oslo University Hospital

Investigators

• Principal Investigator: Per O Iversen, MD, University of Oslo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Per Ole Iversen, MD, Professor, University of Oslo
• ClinicalTrials.gov Identifier: NCT02970240
• Other Study ID Numbers: 2012/571
• First Posted: Nov 21, 2016
• Last Update Posted: Nov 4, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Per Ole Iversen, MD, Professor, University of Oslo: cardiopulmonary exercise testing; inflammation; oxidative status
• Additional relevant MeSH terms: Fatigue Syndrome, Chronic; Encephalomyelitis; Myalgia; Syndrome; Fatigue

Study Results

No Results Posted as of Nov 4, 2020