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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04026425
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ithaca College
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Betsy Keller, Ph.D.Geoff Moore, M.D.
Principal Investigator Affiliation Ithaca CollegeIthaca College
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherOther
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Myalgic Encephalomyelitis, Chronic Fatigue Syndrome
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: ME/CFS

Adults with ME/CFS

Active Comparator: Healthy controls

Healthy, low-active adults

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

ID Med, Torrance, California

Status

Recruiting

Address

ID Med

Torrance, California, 90505

Site Contact

Jared Stevens, B.S.

[email protected]

209-599-7194

Ithaca College, Ithaca, New York

Status

Active, not recruiting

Address

Ithaca College

Ithaca, New York, 14850

Weill Cornell Medicine, New York, New York

Status

Recruiting

Address

Weill Cornell Medicine

New York, New York, 10021

Site Contact

Xiangling Mao, M.S.

[email protected]

212-746-2632