Analysis of Post-exertional Malaise Using a Two-day CPET in People With ME/CFS

July 5, 2023 updated by: Ithaca College

Probing Metabolism, Circulating Inflammatory Molecules, Extracellular Vesicles and Immune Dysregulation in Individual Immune Cells in ME/CFS

This study aims to collect and identify key outcome measures or disease parameters in ME/CFS that are altered during elevated symptoms relative to baseline by gathering information before and after symptom provocation using a two-day cardiopulmonary exercise test.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The phenomenon of post-exertional malaise (PEM), in which an ME/CFS patient's symptoms are elevated following even low-level exertion, is a hallmark feature of the disease. The cause of PEM, like the cause of ME/CFS, is not understood. This study aims to utilize a two-day CPET to invoke PEM. This provides a unique opportunity to collect data on how key outcome measures or disease parameters are altered during elevated symptoms relative to baseline within each patient by gathering information before and after symptom provocation.

A total of 90 participants and 90 controls will undergo CPET testing. Participation will be split amongst three different sites (Ithaca, NY, New York, NY, and Los Angeles, CA). Subjects will be located in urban and rural areas to establish relatively diverse study populations.

This study is a component of the Cornell ME/CFS Collaborative Research Center (CRC). Blood samples taken before and after CPET will be utilized in associated projects with the Cornell ME/CFS CRC. CPET data along with the analysis of blood samples has great potential to reveal why exercise negatively affects ME/CFS patients and thus perhaps why patients are also impaired even before increasing their activity level.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
173

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Torrance, California, United States, 90505
        • ID Med
    • New York
      • Ithaca, New York, United States, 14850
        • Ithaca College
      • New York, New York, United States, 10021
        • Weill Cornell Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Adults with ME/CFS:

Inclusion Criteria:

  • Diagnosed with ME/CFS
  • Adults 18 to 70 years of age

Exclusion Criteria:

  • Recent history of panic attacks within the past 6 months
  • Diagnosis of schizophrenia, major depressive disorder, bipolar disorder, or an anxiety disorder such as OCD or PTSD
  • Hospitalized for a psychological condition within the last 6 months
  • Unwilling to stop taking nutritional supplements, including probiotics, two weeks before the exercise tests.
  • Unwilling to stop pain medication and stimulant medication two days before the exercise tests.
  • Smoker, or stopped smoking less than 1 year ago
  • Pregnant or breastfeeding
  • Diabetic
  • Have an orthopedic limitation that prohibits cycle exercise
  • Excessive alcohol consumption

Healthy Volunteers:

Inclusion Criteria:

  • Healthy
  • Low-active
  • Adults 18 to 70 years of age

Exclusion Criteria:

  • Recent history of panic attacks within the past 6 months
  • Diagnosis of schizophrenia, major depressive disorder, bipolar disorder, or an anxiety disorder such as OCD or PTSD
  • Hospitalized for a psychological condition within the last 6 months
  • Unwilling to stop taking nutritional supplements, including probiotics, two weeks before the exercise tests.
  • Unwilling to stop pain medication and stimulant medication two days before the exercise tests.
  • Smoker, or stopped smoking less than 1 year ago
  • Pregnant or breastfeeding
  • Diabetic
  • Have an orthopedic limitation that prohibits cycle exercise
  • Excessive alcohol consumption

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ME/CFS
Adults with ME/CFS
Other: Two-day cardiopulmonary exercise test
A series of two cardiopulmonary exercise tests (CPETs) performed over two days. Participants will perform a CPET and then will return approximately 24 hours later to perform the second CPET. The CPET begins with 3 minutes of seated rest followed by cycling during incremental workloads which increases 15 watts throughout each minute of exercise. The participant will cycle until volitional exhaustion and/or the participant and/or test administrator determines to stop the test. Actual exercise time usually varies between 8-10 minutes.
Active Comparator: Healthy controls
Healthy, low-active adults
Other: Two-day cardiopulmonary exercise test
A series of two cardiopulmonary exercise tests (CPETs) performed over two days. Participants will perform a CPET and then will return approximately 24 hours later to perform the second CPET. The CPET begins with 3 minutes of seated rest followed by cycling during incremental workloads which increases 15 watts throughout each minute of exercise. The participant will cycle until volitional exhaustion and/or the participant and/or test administrator determines to stop the test. Actual exercise time usually varies between 8-10 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Volume of oxygen consumed at peak effort
Time Frame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Volume of oxygen consumed at peak effort during CPET 1 and during CPET 2.
During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Volume of oxygen consumed at ventilatory/anaerobic threshold (VAT)
Time Frame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
VAT is a non-invasive surrogate measure for anaerobic threshold, which is indicated during incremental exercise by a non-linear increase in rate of carbon dioxide production relative to rate of oxygen consumption.
During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Rate of work performed at peak effort
Time Frame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Rate of work performed at peak effort during CPET 1 and during CPET 2. Rate of work is measured in Watts.
During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Rate of work performed at VAT
Time Frame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Rate of work performed at VAT during CPET 1 and during CPET 2. Rate of work is measured in Watts.
During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Heart rate at peak effort
Time Frame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Heart rate at peak effort during CPET 1 and during CPET 2.
During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Heart rate at VAT
Time Frame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Heart rate at VAT during CPET 1 and during CPET 2.
During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Systolic blood pressure at seated rest
Time Frame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Systolic blood pressure at seated rest 1-minute before the start of CPET 1 and 1-minute before the start of CPET 2.
During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Systolic blood pressure at peak effort
Time Frame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Systolic blood pressure at peak effort during CPET 1 and during CPET 2.
During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Respiratory Exchange Ratio (RER) at peak effort
Time Frame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
RER at peak effort during CPET 1 and during CPET 2. RER is calculated as the rate of carbon dioxide production divided by the rate of oxygen consumption, and during exercise is an indicator of participant effort.
During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ithaca College

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Weill Medical College of Cornell University
Cornell University
Workwell Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Betsy Keller, Ph.D., Ithaca College
  • Study Director: Geoff Moore, M.D., Ithaca College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • U54NS105541 (U.S. NIH Grant/Contract)
  • 5U54NS105541 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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