Myalgic EncephalomyelitisNCT04026425
Analysis of Post-exertional Malaise Using a Two-day CPET in People With ME/CFS
A study testing Two-day cardiopulmonary exercise test in people with Myalgic Encephalomyelitis and Chronic Fatigue Syndrome, run by Ithaca College at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Myalgic Encephalomyelitis, Chronic Fatigue Syndrome
- What is being tested?
- Two-day cardiopulmonary exercise test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2018to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with ME/CFS
- Adults 18 to 70 years of age
- Healthy
- Low-active
- Adults 18 to 70 years of age
Who cannot join
- 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
Show all 21Show fewer
- Pregnant or breastfeeding
- Diabetic
- Have an orthopedic limitation that prohibits cycle exercise
- Excessive alcohol consumption
- Healthy Volunteers:
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Ithaca College
Ithaca, New York, 14850
Weill Cornell Medicine
New York, New York, 10021
ID Med
Torrance, California, 90505
About this study
Official title: 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.
Read the 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.
- Being tested
- Two-day cardiopulmonary exercise test
- Keywords
- cardiopulmonary exercise test (CPET), post-exertional malaise (PEM)
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-day cardiopulmonary exercise testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ME/CFS | Experimental | Adults with ME/CFS Receives: Other: Two-day cardiopulmonary exercise test |
| Healthy controls | Active comparator | Healthy, low-active adults Receives: Other: Two-day cardiopulmonary exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of oxygen consumed at peak effort
Volume of oxygen consumed at peak effort during CPET 1 and during CPET 2.
Measured: 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)
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.
Measured: 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
Rate of work performed at peak effort during CPET 1 and during CPET 2. Rate of work is measured in Watts.
Measured: 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
Rate of work performed at VAT during CPET 1 and during CPET 2. Rate of work is measured in Watts.
Measured: 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
Heart rate at peak effort during CPET 1 and during CPET 2.
Measured: 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
Heart rate at VAT during CPET 1 and during CPET 2.
Measured: 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
Systolic blood pressure at seated rest 1-minute before the start of CPET 1 and 1-minute before the start of CPET 2.
Measured: 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
Systolic blood pressure at peak effort during CPET 1 and during CPET 2.
Measured: 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
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.
Measured: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start1 Aug 2018
- Primary completion15 Mar 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myalgic EncephalomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ithaca College
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University, Weill Medical College of Cornell University, Workwell Foundation
- Responsible party
- Sponsor
- Investigators
- Betsy Keller, Ph.D., Study director, Ithaca CollegeGeoff Moore, M.D., Study director, Ithaca College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026425
- Sponsor's protocol ID
- U54NS105541
- Other IDs
- 5U54NS105541
- Status last verified
- Jul 2023
- First submitted
- 2 Jul 2019
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Keller B, Receno CN, Franconi CJ, Harenberg S, Stevens J, Mao X, Stevens SR, Moore G, Levine S, Chia J, Shungu D, Hanson MR. Cardiopulmonary and metabolic responses during a 2-day CPET in myalgic encephalomyelitis/chronic fatigue syndrome: translating reduced oxygen consumption to impairment status to treatment considerations. J Transl Med. 2024 Jul 5;22(1):627. doi: 10.1186/s12967-024-05410-5.
PubMed 38965566
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probing Metabolism, Circulating Inflammatory Molecules, Extracellular Vesicles and Immune Dysregulation in Individual Immune Cells in ME/CFS
- ClinicalTrials.gov ID
- NCT04026425
- Acronym / sponsor ID
- U54NS105541
- Keywords
- cardiopulmonary exercise test (CPET), post-exertional malaise (PEM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Ithaca CollegeUniversity, hospital or other
- Collaborators
- Cornell University, Weill Medical College of Cornell University, Workwell Foundation
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ME/CFS | Experimental | Other: Two-day cardiopulmonary exercise testAdults with ME/CFS |
| Healthy controls | Active comparator | Other: Two-day cardiopulmonary exercise testHealthy, low-active adults |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with ME/CFS
- Adults 18 to 70 years of age
- Healthy
- Low-active
- Adults 18 to 70 years of age
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Two-day cardiopulmonary exercise testA 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. | Other | Healthy controls, ME/CFS |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Derived from this study: PubMed 38965566Keller B, Receno CN, Franconi CJ, Harenberg S, Stevens J, Mao X, Stevens SR, Moore G, Levine S, Chia J, Shungu D, Hanson MR. Cardiopulmonary and metabolic responses during a 2-day CPET in myalgic encephalomyelitis/chronic fatigue syndrome: translating reduced oxygen consumption to impairment status to treatment considerations. J Transl Med. 2024 Jul 5;22(1):627. doi: 10.1186/s12967-024-05410-5.
- Related informationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betsy Keller, Ph.D. study director
Ithaca College
Geoff Moore, M.D. study director
Ithaca College
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two-day cardiopulmonary exercise test in people with Myalgic Encephalomyelitis and Chronic Fatigue Syndrome, run by Ithaca College at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04026425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.