NCT05145192

COSMED K5 Validation and Reliability Study

Validity and Reliability of the K5 Wearable Metabolic System During High-Intensity Treadmill Testing in Healthy, Young Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 20 Years – 29 Years
• Healthy volunteers: Accepted

Summary

To determine the validity of the K5 metabolic system breath-by-breath analysis setting during a high intensity treadmill running protocol compared to the criterion ParvoMedics TrueOne® 2400 automated metabolic gas analysis system. To determine the test-retest reliability of the K5 metabolic system breath-by-breath analyzer during a high intensity treadmill protocol (Bruce Protocol).

Conditions

• Cardiopulmonary
• Exercise

Interventions

Type	Name	Description
DEVICE	COSMED K5 CPET (Cardiopulmonary Exercise Test)	In this randomized crossover trial of eligible adults, we will compare peak measurements of oxygen consumption (VO2) and carbon dioxide production (VCO2) during three maximal cardiopulmonary stress exercise tests (CPET), each seven to ten days apart. Subjects will be randomized into either the K5 or ParvoMedics (PM) group for their first CPET using a 1:1 randomization scheme and will serve as their own control in the subsequent test seven to ten days after the previous one. After both a K5 and a PM CPETs have been completed, the participants will complete an additional K5 CPET for test-retest reliability. A within-subjects analysis will be performed.
DEVICE	ParvoMedics CPET	ParvoMedics CPET

Timeline

• Start date: 2021-11-29
• Primary completion: 2023-10-10
• Completion: 2023-10-10
• First posted: 2021-12-06
• Last updated: 2025-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study