Chronic Fatigue SyndromeNCT02669212
Myalgic Encephalomyelitis Chronic Fatigue at the National Institutes of Health
A study testing Cardiopulmonary Exercise Test (CPET) in people with Chronic Fatigue Syndrome, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: Post-Infectious Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (PI-ME/CFS) refers to long-lasting and disabling fatigue or malaise, inability to recover after exercise, and physical and emotional discomfort that may occur after a person has an infection. Researchers want to learn more about its causes. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Fatigue Syndrome
- What is being tested?
- Cardiopulmonary Exercise Test (CPET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2016to 11 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult participants aged 18-60 years at the time of enrollment.
- Self-reported completion of at least the 7th grade of school.
- Ability to speak, read, and understand English.
- Willing and able to complete all study procedures
- Participant has a primary care physician at the time of enrollment.
- Able to provide informed consent.
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- Additional inclusion criteria for participants with PI-ME/CFS for the phenotyping visit:
- A self-reported illness narrative of the development of persistent fatigue and post-exertional malaise as the consequence of an acute infection. The persistent fatigue may have an acute onset or become progressively worse over 6 months.
- Licensed Independent Practitioner documentation of ME/CFS onset:
- Medical documentation of absence of symptoms within one year of ME/CFS onset. This may include medical records, letters, or information gathered from telephone calls with study personnel.
- Documentation of a medical evaluation for symptoms of an acute infection or documentation of a medical evaluation of persistent symptoms within 2 months following an assumed infection.
- Persistent fatigue and PEM onset less than 5 years prior to enrollment.
- Additional inclusion criteria for participants with PI-ME/CFS for the exercise stress visit:
- Be unanimously considered to be a case of PI-ME/CFS by the protocol s adjudication committee.
- Meet the 1994 Fukuda Criteria or the 2003 Canadian Consensus Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome or the Institute of Medicine Diagnostic Criteria..
- Have moderate to severe clinical symptom severity:
- Severe fatigue as determined using the Multidimensional Fatigue Inventory (MFI): score of greater than or equal to 13 on the general fatigue subscale or greater than or equal to 10 on the reduced activity subscale.
- Functional impairment as determined using the Short-Form 36 (SF-36): score of less than or equal to 70 physical function subscale, or less than or equal to 50 on role physical subscale, or less than or equal to 75 on social function subscale
- Additional inclusion criteria for healthy volunteer group:
- None
- Additional inclusion criteria for COVID-19 Healthy Volunteers: documented prior COVID19 infection as evidenced by:
- A history of clinical manifestations compatible with COVID-19
- Laboratory evidence of Covid-19 infection:
- Detectionof SARS-CoV-2RNA or antigen in nasopharyngeal swab, sputum, other sample source with Emergency Use Authorization/approval from the FDA; OR
- A positive antibody test using an assay that has received Emergency Use Authorization/approval from the FDA
- Has been recovered from the COVID-19 infection for at least six months and no more than five years.
Who cannot join
- Current or past psychotic disorder including depression with psychosis, bipolar disorder, and schizophrenia
- Current DSM-5-defined major depression disorder, generalized anxiety disorder, post-traumatic stress disorder, panic disorder, or obsessive-compulsive disorder unless managed for more than six months with a stable treatment regimen
- Current or prior substance use disorder as diagnosed on the Structured Clinical Interview for DSM-5 (SCID-5).
- Current suicidal ideation
- History of head injury with loss of consciousness or amnesia lasting greater than a few seconds within lasta five years or lasting greater than 5 minutes at any point during their lifetime. Persons with medical record evidence of post-concussive symptoms lasting more than six months are also excluded.
- Persons with medical record evidence of post-concussive symptoms lasting more than six months are also excluded.
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- Women who are pregnant, actively seeking to become pregnant, or have been pregnant in the year prior to study enrollment.
- Current or previous malignancy. Certain dermatologic malignancies (e.g. basal cell carcinoma) will be allowed. A history of malignancy that have fully resolved with surgical resection only (i.e. no chemotherapy, radiation therapy, or immunotherapy) will be allowed.
- Current systemic immunologic disorder (e.g. Type 1 diabetes, rheumatoid arthritis) will be excluded. Allergies requiring anti-histamines may not be an exclusion, but allergies requiring immunosuppressants may be an exclusion.
- Current or previous long term immune suppressive or immunomodulatory therapy. Systemic steroid use, even short-term, must not have been used within the month prior to enrollment
- Any medical condition (eg, congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, severe osteoarthritis, poorly controlled asthma) that would make the study procedures risky for the participant (e.g. exercise-induced angina and asthma) or that may confound the study results (e.g. untreated obstructive sleep apnea, severe osteoarthritis).
- Participation in a clinical protocol (e.g. anti-inflammatory drug intervention study) which includes an intervention that may affect the results of the current study.
- Inability to perform the bicycling exercise task.
- Clinically significant claustrophobia
- Not willing to allow for research samples to be shared with other researchers.
- Employees or staff at NIH that are directly supervised by the primary investigator or associate investigators.
- Additional exclusion criteria for participants with PI-ME/CFS for phenotyping visit:
- Significant neurological disorder (e.g. neurodegenerative disorder, stroke, epilepsy).
- PI-ME/CFS disease severity that makes it impossible for the volunteer to leave the home or requires inpatient treatment.
- Suspected, probable, or confirmed Lyme disease per 2011 CDC Lyme Disease National Surveillance Case Definitions.
- Underlying illness that may cause fatigue such as thyroid dysfunction, hepatitis, or other systemic diseases.
- Additional exclusion criteria for participants with PI-ME/CFS for exercise stress visit:
- 1. Current (within 1 week) use of prescription or over-the-counter medications, herbal supplements, or nutraceuticals that may influence brain excitability that the potential participant is either unwilling or clinically unable to safely wean off for the duration of the period of the exercise stress visit. The possibility for a potential participant to be weaned off medication will be cooperatively determined by both the clinical investigative team and personal physicians. Examples of medications that influence brain excitability include tricyclic antidepressants, hypnotic, antiepileptic, antipsychotic medication, stimulants, antihistamines, muscle relaxants, dopaminergic medications, and sleep medications.
- Additional exclusion criteria for healthy volunteer group:
- Substantial daily fatigue as determined using PROMIS-SF Fatigue: score of > 17.
- Significant neurological disorder (e.g. neurodegenerative disorder, stroke, epilepsy).
- Current (within 1 week) use of prescription or over-the-counter medications, herbal supplements, or nutraceuticals that may influence brain excitability
- Additional exclusion criteria for COVID-19 healthy volunteer group:
- Substantial daily fatigue as determined using PROMIS-SF Fatigue: score of >17.
- Significant neurological disorder (e.g. neurodegenerative disorder, stroke, epilepsy).
- Current (within 1 week) use of prescription or over-the-counter medications, herbal supplements, or nutraceuticals that may influence brain excitability
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Background:
Post-Infectious Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (PI-ME/CFS) refers to long-lasting and disabling fatigue or malaise, inability to recover after exercise, and physical and emotional discomfort that may occur after a person has an infection. Researchers want to learn more about its causes.
Read more
Objective:
To learn more about PI-ME/CFS.
Eligibility:
Adults ages 18-60 years who have finished at least 7th grade education and either:
have ME/CFS that started after an infection
OR had Lyme disease, were treated, and returned to normal health
OR are healthy volunteers
Design:
Participants will initially have a 2-5 day inpatient visit at the National Institutes of Health Clinical Center in Bethesda. During the visit, participants will have:
Medical history
Physical exam
Intravenous (IV) line. A thin plastic tube is inserted into a vein.
Blood and urine collected
Magnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of their brain. They may get a dye through their IV.
Grip strength tested
Saliva, cheek swab, and stool collected
Tilt table test with measures of body functions such as sweating and breathing, blood pressure, and heart rate and blood and urine sample collection
Collection of blood cells. Participants can choose to have the blood drawn through the IV or through a machine that filters blood cells and returns the liquid blood back into the participant s vein.
Lumbar puncture. Fluid will be removed by placement of a needle between the back bones.
Heart monitoring
Sleep study for participants with PI ME/CFS
Questions about the participant s life and how they are feeling
Questions from a neuropsychologist
Questions from an occupational therapist for participants with PI ME/CFS
Questinos from a nutritionist
After the initial visit participants will return home. Participants evaluated for PI-ME/CFS during the first visit will have their information reviewed by an adjudication panel of experts in the diagnosis and care of ME/CFS to determine if they are eligible to participate in the second study visit.
Eligible participants will be invited back for a second study visit. If a participant was taking certain medications during the first visit, they may be asked to taper off of them prior to the second visit and report any problems. They will also receive an activity monitor, fatigue diary, and nutrition log to use for at least one week prior to their second visit.
Participants who are eligible will return for a 5-10 day inpatient hospital visit at the National Institutes of Health Clinical Center. During the visit, participants will undergo measurements before and up to 96 hours after performing a stationary bike exercise test. The purpose of the exercise test is to provoke ME/CFS symptoms (post-exertional malaise). Tests will be performed before and after exercise testing. These include:
Sleeping in a room that measures how the body uses energy with EEG monitoring
Eating a controlled diet
Performing vigorous exercise for 10-15 minutes
Questions about how participants are feeling
Questions about what participants usually eat
Samples of saliva, blood, urine and stool
Wearing an activity monitor
Having an Xray that measures body composition
Thinking and memory tests
Heart monitoring
Transcranial magnetic stimulation. A brief electrical current to the scalp creates a magnetic pulse that affects brain activity.
Magnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of their brain. They will do thinking and exercise tasks during the MRI.
Lumbar puncture. Fluid will be removed by placement of a needle between the back bones.
Read the detailed description
Objective:
The primary objective is to explore the clinical and biological phenotypes of post-infectious myalgic encephalomyelitis/chronic fatigue syndrome (PI-ME/CFS). The secondary objective is to explore the pathophysiology of fatigue and post-exertional malaise (PEM).
Study population:
Up to 206 persons will be enrolled as part of this protocol. Up to 150 persons aged 18-60 will be part of 3 study groups: 50 ME/CFS patients whose fatigue began after an infection, 50 non-fatigued participants with a documented history of a full recovery from COVID-19 infection, and 50 healthy volunteers. The study has a target of completing all study procedures on 20 enrolled participants in each group. Up to an additional 36 persons reporting a community diagnosis of ME/CFS will be enrolled into focus groups to discuss the experience of post-exertional malaise. Up to an additional 10 healthy volunteers and 10 ME/CFS patients may be enrolled to refine the protocol's electrophysiological and neuroimaging techniques.
Design:
This is a single-center, exploratory, cross-sectional study of PI-ME/CFS. Participants will have a phenotyping visit, which will encompass a 2-5 day long inpatient admission at the NIH Clinical Center. Case status for ME/CFS participants will be determined after the phenotyping visit by a case adjudication process utilizing an expert physician committee and published guidelines. Adjudicated participants meeting inclusion criteria will be invited back to participate in an exercise stress visit, which will encompass a 5-10 day long inpatient admission. Detailed subjective and objective measurements and biological specimens will be serially collected before and up to 96 hours after a peak exercise test capable of inducing post-exertional malaise during this visit. All procedures will be completed on all three study groups to allow for optimal inter-group comparisons.
Outcome measures:
The primary purpose of this protocol is to perform exploratory analysis of collected samples for the generation of new hypotheses regarding ME/CFS. The types of analyses to be performed will be wide ranging. Planned areas of focus include:
- Characterization of the immune system and inflammation at baseline
- Characterization of the pattern of microbiome in collected samples at baseline
- Characterization of bioenergetics, autonomic, and metabolic function in collected samples at baseline
- Characterization of neurocognition at baseline
- Characterization of autonomic function at baseline
- Conditions
- Chronic Fatigue Syndrome
- Being tested
- Cardiopulmonary Exercise Test (CPET)
- Keywords
- Chronic Fatigue Syndrome, Lyme Disease, Healthy Volunteers, Movement Disorder
- Medical subject headings
- Fatigue Syndrome, Chronic, Lyme Disease, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary Exercise Test (CPET)Behavioural
All participants will undergo an exercise stress test
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer Participants | Other | Healthy volunteer participants Receives: Behavioral: Cardiopulmonary Exercise Test (CPET) |
| ME/CFS Participants | Other | Participants with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Receives: Behavioral: Cardiopulmonary Exercise Test (CPET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary Exercise Test (CPET) - ATVO2rel
The Relative Volume of Oxygen at the Anaerobic Threshold (ATVO2rel) was determined during a cardiopulmonary exercise test (CPET). ATVO2rel represents the volume of oxygen being consumed when a participant reaches AT, adjusted for their weight during the CPET. Results compared Healthy Volunteer Participants to ME/CFS Participants.
Measured: At time of AT during CPET
Cardiopulmonary Exercise Test (CPET) - RER
The Respiratory Exchange Ratio (VCO2/VO2) was determined during a cardiopulmonary exercise test (CPET). VCO2/VO2 is calculated by measuring the volume of carbon dioxide and oxygen the participant breathes during CPET. When the volume of carbon dioxide exceeds that of oxygen, it reflects a change from aerobic metabolism to anaerobic metabolism. When a participant has a Respiratory Exchange Ratio (RER) during CPET that is equal or greater than 1.1 it is considered a sufficient exercise effort. Results compared Healthy Volunteer Participants to ME/CFS Participants.
Measured: At time of AT during CPET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study start10 Oct 2016
- Primary completion11 Jan 2022
- Study completion11 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Avindra Nath, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669212
- Sponsor's protocol ID
- 160058
- Other IDs
- 16-N-0058
- Status last verified
- 10 Jun 2022
- First submitted
- 29 Jan 2016
- Last updated
- 18 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
- ClinicalTrials.gov ID
- NCT02669212
- Acronym / sponsor ID
- 160058
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- Chronic Fatigue Syndrome, Lyme Disease, Healthy Volunteers, Movement Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 11 Jan 2022 (actual)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Posted 18 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Post-Infectious Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (PI-ME/CFS) refers to long-lasting and disabling fatigue or malaise, inability to recover after exercise, and physical and emotional discomfort that may occur after a person has an infection. Researchers want to learn more about its causes.
Objective:
To learn more about PI-ME/CFS.
Eligibility:
Adults ages 18-60 years who have finished at least 7th grade education and either:
have ME/CFS that started after an infection
OR had Lyme disease, were treated, and returned to normal health
OR are healthy volunteers
Design:
Participants will initially have a 2-5 day inpatient visit at the National Institutes of Health Clinical Center in Bethesda. During the visit, participants will have:
Medical history
Physical exam
Intravenous (IV) line. A thin plastic tube is inserted into a vein.
Blood and urine collected
Magnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of their brain. They may get a dye through their IV.
Grip strength tested
Saliva, cheek swab, and stool collected
Tilt table test with measures of body functions such as sweating and breathing, blood pressure, and heart rate and blood and urine sample collection
Collection of blood cells. Participants can choose to have the blood drawn through the IV or through a machine that filters blood cells and returns the liquid blood back into the participant s vein.
Lumbar puncture. Fluid will be removed by placement of a needle between the back bones.
Heart monitoring
Sleep study for participants with PI ME/CFS
Questions about the participant s life and how they are feeling
Questions from a neuropsychologist
Questions from an occupational therapist for participants with PI ME/CFS
Questinos from a nutritionist
After the initial visit participants will return home. Participants evaluated for PI-ME/CFS during the first visit will have their information reviewed by an adjudication panel of experts in the diagnosis and care of ME/CFS to determine if they are eligible to participate in the second study visit.
Eligible participants will be invited back for a second study visit. If a participant was taking certain medications during the first visit, they may be asked to taper off of them prior to the second visit and report any problems. They will also receive an activity monitor, fatigue diary, and nutrition log to use for at least one week prior to their second visit.
Participants who are eligible will return for a 5-10 day inpatient hospital visit at the National Institutes of Health Clinical Center. During the visit, participants will undergo measurements before and up to 96 hours after performing a stationary bike exercise test. The purpose of the exercise test is to provoke ME/CFS symptoms (post-exertional malaise). Tests will be performed before and after exercise testing. These include:
Sleeping in a room that measures how the body uses energy with EEG monitoring
Eating a controlled diet
Performing vigorous exercise for 10-15 minutes
Questions about how participants are feeling
Questions about what participants usually eat
Samples of saliva, blood, urine and stool
Wearing an activity monitor
Having an Xray that measures body composition
Thinking and memory tests
Heart monitoring
Transcranial magnetic stimulation. A brief electrical current to the scalp creates a magnetic pulse that affects brain activity.
Magnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of their brain. They will do thinking and exercise tasks during the MRI.
Lumbar puncture. Fluid will be removed by placement of a needle between the back bones.
Detailed description
Objective:
The primary objective is to explore the clinical and biological phenotypes of post-infectious myalgic encephalomyelitis/chronic fatigue syndrome (PI-ME/CFS). The secondary objective is to explore the pathophysiology of fatigue and post-exertional malaise (PEM).
Study population:
Up to 206 persons will be enrolled as part of this protocol. Up to 150 persons aged 18-60 will be part of 3 study groups: 50 ME/CFS patients whose fatigue began after an infection, 50 non-fatigued participants with a documented history of a full recovery from COVID-19 infection, and 50 healthy volunteers. The study has a target of completing all study procedures on 20 enrolled participants in each group. Up to an additional 36 persons reporting a community diagnosis of ME/CFS will be enrolled into focus groups to discuss the experience of post-exertional malaise. Up to an additional 10 healthy volunteers and 10 ME/CFS patients may be enrolled to refine the protocol's electrophysiological and neuroimaging techniques.
Design:
This is a single-center, exploratory, cross-sectional study of PI-ME/CFS. Participants will have a phenotyping visit, which will encompass a 2-5 day long inpatient admission at the NIH Clinical Center. Case status for ME/CFS participants will be determined after the phenotyping visit by a case adjudication process utilizing an expert physician committee and published guidelines. Adjudicated participants meeting inclusion criteria will be invited back to participate in an exercise stress visit, which will encompass a 5-10 day long inpatient admission. Detailed subjective and objective measurements and biological specimens will be serially collected before and up to 96 hours after a peak exercise test capable of inducing post-exertional malaise during this visit. All procedures will be completed on all three study groups to allow for optimal inter-group comparisons.
Outcome measures:
The primary purpose of this protocol is to perform exploratory analysis of collected samples for the generation of new hypotheses regarding ME/CFS. The types of analyses to be performed will be wide ranging. Planned areas of focus include:
- Characterization of the immune system and inflammation at baseline
- Characterization of the pattern of microbiome in collected samples at baseline
- Characterization of bioenergetics, autonomic, and metabolic function in collected samples at baseline
- Characterization of neurocognition at baseline
- Characterization of autonomic function at baseline
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer Participants | Other | Behavioral: Cardiopulmonary Exercise Test (CPET)Healthy volunteer participants |
| ME/CFS Participants | Other | Behavioral: Cardiopulmonary Exercise Test (CPET)Participants with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (26 listed)
- Additional inclusion criteria for participants with PI-ME/CFS for the phenotyping visit:
- Additional inclusion criteria for participants with PI-ME/CFS for the exercise stress visit:
- Additional inclusion criteria for healthy volunteer group:
- None
- Additional inclusion criteria for COVID-19 Healthy Volunteers: documented prior COVID19 infection as evidenced by:
Key exclusion criteria (31 listed)
- Persons with medical record evidence of post-concussive symptoms lasting more than six months are also excluded.
- Additional exclusion criteria for participants with PI-ME/CFS for phenotyping visit:
- Additional exclusion criteria for participants with PI-ME/CFS for exercise stress visit:
- 1. Current (within 1 week) use of prescription or over-the-counter medications, herbal supplements, or nutraceuticals that may influence brain excitability that the potential participant is either unwilling or clinically unable to safely wean off for the duration of the period of the exercise stress visit. The possibility for a potential participant to be weaned off medication will be cooperatively determined by both the clinical investigative team and personal physicians. Examples of medications that influence brain excitability include tricyclic antidepressants, hypnotic, antiepileptic, antipsychotic medication, stimulants, antihistamines, muscle relaxants, dopaminergic medications, and sleep medications.
- Additional exclusion criteria for healthy volunteer group:
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 |
|---|---|---|
| Cardiopulmonary Exercise Test (CPET)All participants will undergo an exercise stress test | Behavioural | Healthy Volunteer Participants, ME/CFS Participants |
Primary outcome
Cardiopulmonary Exercise Test (CPET) - ATVO2rel
Time frame: At time of AT during CPET
The Relative Volume of Oxygen at the Anaerobic Threshold (ATVO2rel) was determined during a cardiopulmonary exercise test (CPET). ATVO2rel represents the volume of oxygen being consumed when a participant reaches AT, adjusted for their weight during the CPET. Results compared Healthy Volunteer Participants to ME/CFS Participants.
Cardiopulmonary Exercise Test (CPET) - RER
Time frame: At time of AT during CPET
The Respiratory Exchange Ratio (VCO2/VO2) was determined during a cardiopulmonary exercise test (CPET). VCO2/VO2 is calculated by measuring the volume of carbon dioxide and oxygen the participant breathes during CPET. When the volume of carbon dioxide exceeds that of oxygen, it reflects a change from aerobic metabolism to anaerobic metabolism. When a participant has a Respiratory Exchange Ratio (RER) during CPET that is equal or greater than 1.1 it is considered a sufficient exercise effort. Results compared Healthy Volunteer Participants to ME/CFS Participants.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink 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.
Avindra Nath, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiopulmonary Exercise Test (CPET) in people with Chronic Fatigue Syndrome, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site 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 26 inclusion and 31 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 18 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cardiopulmonary Exercise Test (CPET) - ATVO2rel (time frame: At time of AT during CPET). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2023.