COSMED K5 Validation and Reliability Study

Baylor Scott and White Health (BSWH)

Status: Completed

Conditions: Cardiopulmonary; Exercise

Treatments: Device: COSMED K5 CPET (Cardiopulmonary Exercise Test); Device: ParvoMedics CPET

Study type: Interventional

Funder types: Other

Identifiers

NCT05145192

021-348

Details and patient eligibility

About

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).

Enrollment: 34 patients

Sex: All

Ages: 20 to 29 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

COSMED K5 CPET

Experimental group

Description:

Participants in this arm will complete the CPET using the COSMED K5 wearable metabolic system at first visit and the ParvoMedics TrueOne® 2400 automated metabolic gas analysis system at second visit.

Treatment:

Device: ParvoMedics CPET

Device: COSMED K5 CPET (Cardiopulmonary Exercise Test)

ParvoMedics CPET

Active Comparator group

Description:

Participants in this arm will complete the CPET using the ParvoMedics TrueOne® 2400 automated metabolic gas analysis system at first visit and the COSMED K5 wearable metabolic system at second visit.

Treatment:

Device: ParvoMedics CPET

Device: COSMED K5 CPET (Cardiopulmonary Exercise Test)