Not Yet RecruitingNot Applicable

Calibre vs. COSMED

40 participantsStarted 2026-09

Plain-language summary

This study evaluates agreement between the Calibre device and the COSMED Quark CPET system for measurement of cardiorespiratory fitness parameters during maximal exercise testing in adults aged 18-55 years.

Who can participate

Age range

18 Years – 55 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.

Inclusion Criteria: * Age 18-55 * Able to speak English * Able to provide informed consent Exclusion Criteria: * Acute myocardial infarction * Unstable angina * Syncope * Uncontrolled asthma * Arterial desaturation at rest on room air \<85% * Severe untreated arterial hypertension at rest (\>200 mm Hg systolic, \>120 mm Hg diastolic) * Significant pulmonary hypertension * Active thrombosis of the lower extremity, unless treated for at least 2 weeks prior to participation. * Within 2 weeks of acute symptomatic pulmonary embolus * Considered inappropriate to participate by Principal Investigator * Previously experienced a heart attack * Pregnancy

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

VO₂ peak correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED

Timeframe: During CPET testing across Visit 1 and Visit 2, up to 7 days.

VO₂ peak agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED

Timeframe: During CPET testing across Visit 1 and Visit 2, up to 7 days.

Anaerobic threshold correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED

Timeframe: During CPET testing across Visit 1 and Visit 2, up to 7 days

Anaerobic threshold agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED

Timeframe: During CPET testing across Visit 1 and Visit 2, up to 7 days

VE/VCO₂ correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED

Timeframe: During CPET testing across Visit 1 and Visit 2, up to 7 days

VE/VCO₂ agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED

Timeframe: During CPET testing across Visit 1 and Visit 2, up to 7 days

Trial details

NCT IDNCT07596108

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07

View on ClinicalTrials.gov More Cardiorespiratory Fitness trials