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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
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.
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.
VO₂ peak correlation, as measured by Pearson or Spearman correlation coefficient between Calibre and COSMED
VO₂ peak measured during CPET will be compared between devices using Pearson or Spearman correlation coefficient, depending on data distribution.
Time frame: 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
VO₂ peak measured during CPET will be compared between devices using Bland-Altman analysis to estimate average bias and limits of agreement.
Time frame: 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
Anaerobic threshold measured during CPET will be compared between devices using Pearson or Spearman correlation coefficient, depending on data distribution.
Time frame: 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
Anaerobic threshold measured during CPET will be compared between devices using Bland-Altman analysis to estimate average bias and limits of agreement.
Time frame: 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
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.
Time frame: 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
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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.
Time frame: During CPET testing across Visit 1 and Visit 2, up to 7 days