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Cardiopulmonary Testing in ME/CFS to Improve Diagnostic Accuracy

NCT ID: NCT02970240

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2020-11-30

Brief Summary

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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

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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.

Conditions

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Myalgic Encephalomyelitis Chronic Fatigue Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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ME/CFS group

Patients with a verified diagnosis of ME/CFS according to the Canada criteria

Cardiopulmonary testing

Intervention Type PROCEDURE

A 2-day consecutive testing on an ergometer cycle

Fatigue group

Patients with fatigue, but not ME/CFS

Cardiopulmonary testing

Intervention Type PROCEDURE

A 2-day consecutive testing on an ergometer cycle

Control group

Healthy control persons

Cardiopulmonary testing

Intervention Type PROCEDURE

A 2-day consecutive testing on an ergometer cycle

Interventions

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Cardiopulmonary testing

A 2-day consecutive testing on an ergometer cycle

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oslo

OTHER

Sponsor Role lead

The Glittre Clinic

UNKNOWN

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

Responsible Party

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Per Ole Iversen, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Per O Iversen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Locations

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Glittre Clinic

Hakadal, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2012/571

Identifier Type: -

Identifier Source: org_study_id