Cardiorespiratory Fitness
Conditions
Keywords
Cardiopulmonary Exercise Testing, VO2 Max, Exercise Physiology
Brief 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.
Interventions
DEVICECOSMED Quark CPET metabolic cart
FDA-cleared cardiopulmonary exercise testing (CPET) metabolic cart used as the reference comparator for measurement of respiratory gas exchange and ventilatory parameters during ramp cycle ergometry. Participants wear a facemask connected to the system for breath-by-breath measurement of oxygen consumption (VO2), carbon dioxide production (VCO2), minute ventilation (VE), anaerobic threshold, and ventilatory efficiency during maximal exercise testing.
DEVICECalibre Biometrics
Investigational wearable facemask device with integrated sensors for breath-by-breath measurement of respiratory gas exchange and ventilatory parameters during cardiopulmonary exercise testing, evaluated against the COSMED Quark CPET reference system.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VO₂ peak correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED | During CPET testing across Visit 1 and Visit 2, up to 7 days. | VO₂ peak measured during CPET will be compared between devices using Pearson or Spearman correlation coefficient, depending on data distribution. |
| VO₂ peak agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED | During CPET testing across Visit 1 and Visit 2, up to 7 days. | VO₂ peak measured during CPET will be compared between devices using Bland-Altman analysis to estimate average bias and limits of agreement. |
| Anaerobic threshold correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED | During CPET testing across Visit 1 and Visit 2, up to 7 days | Anaerobic threshold measured during CPET will be compared between devices using Pearson or Spearman correlation coefficient, depending on data distribution. |
| Anaerobic threshold agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED | During CPET testing across Visit 1 and Visit 2, up to 7 days | Anaerobic threshold measured during CPET will be compared between devices using Bland-Altman analysis to estimate average bias and limits of agreement. |
| VE/VCO₂ correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED | During CPET testing across Visit 1 and Visit 2, up to 7 days | Ventilatory equivalent for carbon dioxide (VE/VCO₂) measured during CPET will be compared between devices using Pearson or Spearman correlation coefficient, depending on data distribution. |
| VE/VCO₂ agreement, as measured by Bland-Altman bias and limits of agreement between Calibre and COSMED | During CPET testing across Visit 1 and Visit 2, up to 7 days | Ventilatory equivalent for carbon dioxide (VE/VCO₂) measured during CPET will be compared between devices using Bland-Altman analysis to estimate average bias and limits of agreement. |
Contacts
PRINCIPAL_INVESTIGATORDavid MacLeod, M.B.B.S.
Duke University
Outcome results
None listed