An interventional study of Two-day cardiopulmonary exercise test in Myalgic Encephalomyelitis and Chronic Fatigue Syndrome, sponsored by Ithaca College. Completed at 3 sites in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-07.
Sponsored by Ithaca College · Not applicable, Interventional, and Basic science
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Among 86 studies in Fatigue Syndrome, Chronic with a site in United States — 21 open to participants now, 24 under way, none of them phase 3. Fatigue Syndrome, Chronic · United States.
Among the 86 studies in Fatigue Syndrome, Chronic with a site in United States, this one is the 6th largest by enrollment of the 58 interventional ones that give a count, is one of 2 that started in 2018, is one of 30 with no phase, and was the 48th registered.
264 studies on the registry are indexed under Fatigue Syndrome, Chronic; 62 are open to participants now.
Browse Fatigue Syndrome, Chronic studies →21 of the 86 studies in Fatigue Syndrome, Chronic with a site in United States are open now. Recruiting first, the newest first:
Fred Friedberg · Sites in United States
Ages 18–65
University of Alabama at Birmingham · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+
University of California, San Francisco · Sites in United States
Ages 18+ · Healthy volunteers
IMMUNOe Research Centers · Sites in United States
Ages 18–90
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 44 Fatigue Syndrome, Chronic studies recruiting now, 18 (41%) set no upper age limit and 20 (45%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · healthy volunteers too.
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86 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 17 · Phase 3 1 · Phase 4 5
First in 1994; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 173 is above the median of 60 across 178 interventional studies indexed under Fatigue Syndrome, Chronic.
Median enrollment 50 across the 58 interventional studies, 152 across the 26 observational. Of the 47 that completed or were terminated, 15 (32%) have results posted.
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10 of 86 have an industry lead sponsor. The 10 most frequent:
Ithaca College is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Ithaca College has 1 study filed under Fatigue Syndrome, Chronic — fewer than ten, so there is no comparison to draw.
10 of the studies in Fatigue Syndrome, Chronic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06511050Icahn School of Medicine at Mount SinaiLumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome | 2026-12 |
| NCT06585254Icahn School of Medicine at Mount SinaitVNS in Long COVID-19 | 2026-12-31 |
| NCT04049331Seattle Institute for Biomedical and Clinical ResearchTestosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone | 2027-01-30 |
| NCT04542161Weill Medical College of Cornell UniversityAssessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome | 2027-04-30 |
| NCT07600320Icahn School of Medicine at Mount SinaiFareon Open Label Device Clinical Trial | 2027-04-30 |
Add all 10 to your calendar (.ics) → With an account.
Among the 86 studies in Fatigue Syndrome, Chronic with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Adults with ME/CFS:
Inclusion Criteria:
Exclusion Criteria:
Healthy Volunteers:
Inclusion Criteria:
Exclusion Criteria:
Adults with ME/CFS
Other: Two-day cardiopulmonary exercise test
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.
Volume of oxygen consumed at peak effort
Volume of oxygen consumed at peak effort during CPET 1 and during CPET 2.
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 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.
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
Rate of work performed at peak effort during CPET 1 and during CPET 2. Rate of work is measured in Watts.
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
Rate of work performed at VAT during CPET 1 and during CPET 2. Rate of work is measured in Watts.
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
Heart rate at peak effort during CPET 1 and during CPET 2.
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
Heart rate at VAT during CPET 1 and during CPET 2.
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
Systolic blood pressure at seated rest 1-minute before the start of CPET 1 and 1-minute before the start of CPET 2.
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
Systolic blood pressure at peak effort during CPET 1 and during CPET 2.
Time frame: 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.
Time frame: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.
Ran from Aug 2018 to primary completion in Mar 2022, 43 months.
Of 73 non-industry interventional studies with no phase under Fatigue Syndrome, Chronic, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 43 months is above that.
Counting every sponsor, half of 78 studies reached it within 23 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Ithaca College