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

Primary Purpose

Myalgic Encephalomyelitis, Chronic Fatigue Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Two-day cardiopulmonary exercise test

About this trial

This is an interventional basic science trial for Myalgic Encephalomyelitis focused on measuring cardiopulmonary exercise test (CPET), post-exertional malaise (PEM)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

ID Med
Ithaca College
Weill Cornell Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ME/CFS

Healthy controls

Arm Description

Adults with ME/CFS

Healthy, low-active adults

Outcomes

Primary Outcome Measures

Volume of oxygen consumed at peak effort

Volume of oxygen consumed at peak effort during CPET 1 and during CPET 2.

Volume of oxygen consumed at ventilatory/anaerobic threshold (VAT)

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.

Rate of work performed at peak effort

Rate of work performed at peak effort during CPET 1 and during CPET 2. Rate of work is measured in Watts.

Rate of work performed at VAT

Rate of work performed at VAT during CPET 1 and during CPET 2. Rate of work is measured in Watts.

Heart rate at peak effort

Heart rate at peak effort during CPET 1 and during CPET 2.

Heart rate at VAT

Heart rate at VAT during CPET 1 and during CPET 2.

Systolic blood pressure at seated rest

Systolic blood pressure at seated rest 1-minute before the start of CPET 1 and 1-minute before the start of CPET 2.

Systolic blood pressure at peak effort

Systolic blood pressure at peak effort during CPET 1 and during CPET 2.

Respiratory Exchange Ratio (RER) at peak effort

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04026425

First Posted

July 2, 2019

Last Updated

July 5, 2023

Sponsor

Ithaca College

Collaborators

Cornell University, Weill Medical College of Cornell University, Workwell Foundation

1. Study Identification

Unique Protocol Identification Number

NCT04026425

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

March 15, 2022 (Actual)

Study Completion Date

March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ithaca College

Collaborators

Cornell University, Weill Medical College of Cornell University, Workwell Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myalgic Encephalomyelitis, Chronic Fatigue Syndrome

Keywords

cardiopulmonary exercise test (CPET), post-exertional malaise (PEM)

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

173 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ME/CFS

Arm Type

Experimental

Arm Description

Adults with ME/CFS

Arm Title

Healthy controls

Arm Type

Active Comparator

Arm Description

Healthy, low-active adults

Intervention Type

Other

Intervention Name(s)

Two-day cardiopulmonary exercise test

Intervention Description

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.

Primary Outcome Measure Information:

Title

Volume of oxygen consumed at peak effort

Description

Volume of oxygen consumed at peak effort during CPET 1 and during CPET 2.

Time Frame