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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05145192
Acronym
K5
Enrollment
34
Registered
2021-12-06
Start date
2021-11-29
Completion date
2023-10-10
Last updated
2025-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopulmonary, Exercise

Brief 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).

Interventions

DEVICECOSMED 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.

DEVICEParvoMedics CPET

ParvoMedics CPET

Sponsors

Baylor Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 29 Years
Healthy volunteers
Yes

Inclusion criteria

* 20-29 years of age

Exclusion criteria

* Pregnancy * Children * Inmates * Neuromotor, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise or conditions preventing cooperation * Contraindications to Symptom-limited Maximal Exercise Testing * Metabolic disease * Pacemakers/Implantable devices * Supplemental Oxygen use * Diagnosis of severe arterial hypertension * Uncontrolled asthma

Design outcomes

Primary

MeasureTime frameDescription
Oxygen consumption (VO2), mL/minAt first assessment, during week one.Using metabolic cart, VO2 will be recorded.
Carbon dioxide production (VCO2), mL/minAt first assessment, during week one.Using metabolic cart, VCO2 will be recorded.

Secondary

MeasureTime frameDescription
Breathing Reserve, %At first assessment, during week one.Using metabolic cart, breathing reserve will be recorded.
Tidal Volume, LAt first assessment, during week one.Using metabolic cart, tidal volume will be recorded.
Respiratory Exchange Ratio (RER)At first assessment, during week one.Using metabolic cart, respiratory exchange ratio will be recorded.
Fractional expired oxygen (FEO2)At first assessment, during week one.Using metabolic cart, fractional expired oxygen will be recorded.
Fractional expired carbon dioxide (FECO2)At first assessment, during week one.Using metabolic cart, fractional expired carbon dioxide will be recorded.
Respiratory Frequency, /minAt first assessment, during week one.Using metabolic cart, respiratory frequency will be recorded.
Minute Ventilation, L/minAt first assessment, during week one.Using metabolic cart, minute ventilation will be recorded.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026