CompletedNot Applicable

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

United States173 participantsStarted 2018-08-01

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 alcoho…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Volume of oxygen consumed at peak effort

Timeframe: 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)

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.

Trial details

NCT IDNCT04026425

SponsorIthaca College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-15

View on ClinicalTrials.gov More Myalgic Encephalomyelitis trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Volume of oxygen consumed at peak effort

Timeframe: 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)

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: During intervention on day 1 and during intervention on day 2; assessed through study completion, approximately 4 years from study start date.