<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02970240</url>
  </required_header>
  <id_info>
    <org_study_id>2012/571</org_study_id>
    <nct_id>NCT02970240</nct_id>
  </id_info>
  <brief_title>Cardiopulmonary Testing in ME/CFS to Improve Diagnostic Accuracy</brief_title>
  <official_title>Cardiopulmonary Exercise Testing as a Diagnostic Tool and a Quantitative Measure of Post-exertional Malaise in Myalgic Encephalopathy/Chronic Fatigue Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Glittre Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oslo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Circumstantial evidence suggests that patients diagnosed with myalgic encephalopathy/chronic&#xD;
      fatigue syndrome (ME/CFS) perform worse on day 2 in a 2-day consecutive cardiopulmonary&#xD;
      exercise test (CPET). The aim of this study is to examine if CPET can distinguish between&#xD;
      ME/CFS patients and healthy controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Myalgic encephalopathy/chronic fatigue syndrome (ME/CFS) leads to a substantial reduction in&#xD;
      activity level. Cardiopulmonary exercise testing (CPET) quantifies physical performance, or&#xD;
      functional capacity, by direct measurements of the maximal oxygen uptake (VO2max). Functional&#xD;
      capacity is the ability of an individual to perform aerobic work as defined by the VO2max,&#xD;
      and the assessment of functional capacity reflects the ability to perform activities of daily&#xD;
      living that require sustained aerobic metabolism.&#xD;
&#xD;
      To the best of knowledge few robustly designed studies on repeated CPET in ME/CFS are&#xD;
      published, and they demonstrated a significant reduction in functional capacity expressed as&#xD;
      VO2max and anaerobic threshold. This marked functional decline on the second test has&#xD;
      apparently not been described for any other chronic, disabling conditions, and might&#xD;
      represent a possible diagnostic tool for ME/CFS; hence the investigators will examine this.&#xD;
      In addition they will examine other biological markers (e.g. cytokines and anti-oxidative&#xD;
      compounds) before and after the exercise tests to test if the groups can be further&#xD;
      distinguished.&#xD;
&#xD;
      The main aim of this study is to evaluate the use of repeated CPET as an objective diagnostic&#xD;
      marker of ME/CFS. Specifically the investigators want to address the following questions:&#xD;
&#xD;
      I. Will patients with ME/CFS demonstrate a significant reduction in VO2max compared to&#xD;
      healthy individuals? If such a difference can be demonstrated, is it unique for patients with&#xD;
      ME/CFS classified according to the strictest criteria compared to others with longstanding&#xD;
      fatigue?&#xD;
&#xD;
      II. What is the blood lactate profile before, during and after CPET?&#xD;
&#xD;
      III. Are there any correlations between the decline in VO2max and other biological variables&#xD;
      such as markers of oxidative stress, immune dysregulation or metabolic dysfunction?&#xD;
&#xD;
      IV. Is cardiac function impaired among ME/CFS patients as assessed by ecco-cardiography?&#xD;
&#xD;
      Three groups will be included: (i) ME/CFS patients; (ii) patients with fatigue, but not&#xD;
      MF/CFS; and (iii) healthy controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2014</start_date>
  <completion_date type="Actual">November 2020</completion_date>
  <primary_completion_date type="Actual">April 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Maximal oxygen uptake</measure>
    <time_frame>At 48 hour</time_frame>
    <description>Measurement of oxygen uptake during ergometer cycling</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lactate accumulation</measure>
    <time_frame>At 48 hour</time_frame>
    <description>Regular sampling of blood for measurements of lactate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine profile</measure>
    <time_frame>At 48 hour</time_frame>
    <description>Regular sampling of blood for measurements of cytokines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunophenotyping</measure>
    <time_frame>At 48 hour</time_frame>
    <description>Regular sampling of blood for measurements of cell surface markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac status</measure>
    <time_frame>At 48 hour</time_frame>
    <description>Measurements of Cardiac function using ecco-cardiography</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">33</enrollment>
  <condition>Myalgic Encephalomyelitis</condition>
  <condition>Chronic Fatigue Syndrome</condition>
  <arm_group>
    <arm_group_label>ME/CFS group</arm_group_label>
    <description>Patients with a verified diagnosis of ME/CFS according to the Canada criteria</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fatigue group</arm_group_label>
    <description>Patients with fatigue, but not ME/CFS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Healthy control persons</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cardiopulmonary testing</intervention_name>
    <description>A 2-day consecutive testing on an ergometer cycle</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Fatigue group</arm_group_label>
    <arm_group_label>ME/CFS group</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        1. Patients with ME/CFS&#xD;
&#xD;
          2. Patients with fatigue but not ME/CFS&#xD;
&#xD;
          3. Healthy controls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with ME/CFS according to the Canadian and Fukuda criteria; miid to&#xD;
             moderately affected)&#xD;
&#xD;
          -  Provide written consent&#xD;
&#xD;
          -  Able to perform the test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not provided written consent&#xD;
&#xD;
          -  Unable to perform the test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Per O Iversen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Glittre Clinic</name>
      <address>
        <city>Hakadal</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oslo</investigator_affiliation>
    <investigator_full_name>Per Ole Iversen, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>cardiopulmonary exercise testing</keyword>
  <keyword>inflammation</keyword>
  <keyword>oxidative status</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Encephalomyelitis</mesh_term>
    <mesh_term>Fatigue Syndrome, Chronic</mesh_term>
    <mesh_term>Myalgia</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02970240
org study id: 2012/571
nct id: NCT02970240
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
observational model: Case-Control
time perspective: Prospective
measure: Maximal oxygen uptake
time frame: At 48 hour
description: Measurement of oxygen uptake during ergometer cycling
measure: Lactate accumulation
time frame: At 48 hour
description: Regular sampling of blood for measurements of lactate
measure: Cytokine profile
time frame: At 48 hour
description: Regular sampling of blood for measurements of cytokines
measure: Immunophenotyping
time frame: At 48 hour
description: Regular sampling of blood for measurements of cell surface markers
measure: Cardiac status
time frame: At 48 hour
description: Measurements of Cardiac function using ecco-cardiography
arm group label: ME/CFS group
description: Patients with a verified diagnosis of ME/CFS according to the Canada criteria
arm group label: Fatigue group
description: Patients with fatigue, but not ME/CFS
arm group label: Control group
description: Healthy control persons
intervention type: Procedure
intervention name: Cardiopulmonary testing
description: A 2-day consecutive testing on an ergometer cycle
arm group label: Control group
arm group label: Fatigue group
arm group label: ME/CFS group
Whole blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Per O Iversen, MD
role: Principal Investigator
affiliation: University of Oslo
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: University of Oslo
investigator full name: Per Ole Iversen, MD
investigator title: Professor
mesh term: Encephalomyelitis
mesh term: Fatigue Syndrome, Chronic
mesh term: Myalgia
mesh term: Syndrome
mesh term: Fatigue
sharing ipd: No