NCT02970240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

4.8 years

First QC Date

November 14, 2016

Last Update Submit

November 3, 2020

Conditions

Myalgic EncephalomyelitisChronic Fatigue Syndrome

Keywords

cardiopulmonary exercise testinginflammationoxidative status

Outcome Measures

Primary Outcomes (1)

  • Maximal oxygen uptake

    Measurement of oxygen uptake during ergometer cycling

    At 48 hour

Secondary Outcomes (4)

  • Lactate accumulation

    At 48 hour

  • Cytokine profile

    At 48 hour

  • Immunophenotyping

    At 48 hour

  • Cardiac status

    At 48 hour

Study Arms (3)

ME/CFS group

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

Procedure: Cardiopulmonary testing

Fatigue group

Patients with fatigue, but not ME/CFS

Procedure: Cardiopulmonary testing

Control group

Healthy control persons

Procedure: Cardiopulmonary testing

Interventions

Cardiopulmonary testingPROCEDURE

A 2-day consecutive testing on an ergometer cycle

Control groupFatigue groupME/CFS group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Patients with ME/CFS 2. Patients with fatigue but not ME/CFS 3. Healthy controls

You may qualify if:

  • Diagnosed with ME/CFS according to the Canadian and Fukuda criteria; miid to moderately affected)
  • Provide written consent
  • Able to perform the test

You may not qualify if:

  • Not provided written consent
  • Unable to perform the test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glittre Clinic

Hakadal, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Fatigue Syndrome, ChronicInflammation

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Per O Iversen, MD

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 21, 2016

Study Start

June 1, 2014

Primary Completion

April 1, 2019

Study Completion

November 1, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)