COSMED K5 Validation and Reliability Study

Baylor Research Institute34 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Cardiopulmonary Exercise

Interventions

COSMED K5 CPET (Cardiopulmonary Exercise Test)DEVICE

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.

ParvoMedics CPETDEVICE

ParvoMedics CPET

Eligibility

Sex: ALLMin age: 20 YearsMax age: 29 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Baylor Scott and White Sports Therapy and Research

Frisco, Texas, United States

Outcomes

Primary Outcomes

Oxygen consumption (VO2), mL/min

Using metabolic cart, VO2 will be recorded.

Time frame: At first assessment, during week one.

Oxygen consumption (VO2), mL/min

Using metabolic cart, VO2 will be recorded.

Time frame: At second assessment, during week two.

Oxygen consumption (VO2), mL/min

Using metabolic cart, VO2 will be recorded.

Time frame: At third assessment, during week three.

Carbon dioxide production (VCO2), mL/min

Using metabolic cart, VCO2 will be recorded.

Time frame: At first assessment, during week one.

Carbon dioxide production (VCO2), mL/min

Using metabolic cart, VCO2 will be recorded.

Time frame: At second assessment, during week two.

Carbon dioxide production (VCO2), mL/min

Using metabolic cart, VCO2 will be recorded.

Time frame: At third assessment, during week three.

Secondary Outcomes

Respiratory Exchange Ratio (RER)

Using metabolic cart, respiratory exchange ratio will be recorded.

Time frame: At first assessment, during week one.

Respiratory Exchange Ratio (RER)

Using metabolic cart, respiratory exchange ratio will be recorded.

Time frame: At second assessment, during week two.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Respiratory Exchange Ratio (RER)

Using metabolic cart, respiratory exchange ratio will be recorded.

Time frame: At third assessment, during week three.

Minute Ventilation, L/min

Using metabolic cart, minute ventilation will be recorded.

Time frame: At first assessment, during week one.

Minute Ventilation, L/min

Using metabolic cart, minute ventilation will be recorded.

Time frame: At second assessment, during week two.

Minute Ventilation, L/min

Using metabolic cart, minute ventilation will be recorded.

Time frame: At third assessment, during week three.

Breathing Reserve, %

Using metabolic cart, breathing reserve will be recorded.

Time frame: At first assessment, during week one.

Breathing Reserve, %

Using metabolic cart, breathing reserve will be recorded.

Time frame: At second assessment, during week two.

Breathing Reserve, %

Using metabolic cart, breathing reserve will be recorded.

Time frame: At third assessment, during week three.

Tidal Volume, L

Using metabolic cart, tidal volume will be recorded.

Time frame: At first assessment, during week one.

Tidal Volume, L

Using metabolic cart, tidal volume will be recorded.

Time frame: At second assessment, during week two.

Tidal Volume, L

Using metabolic cart, tidal volume will be recorded.

Time frame: At third assessment, during week three.

Respiratory Frequency, /min

Using metabolic cart, respiratory frequency will be recorded.

Time frame: At first assessment, during week one.

Respiratory Frequency, /min

Using metabolic cart, respiratory frequency will be recorded.

Time frame: At second assessment, during week two.

Respiratory Frequency, /min

Using metabolic cart, respiratory frequency will be recorded.

Time frame: At third assessment, during week three.

Fractional expired oxygen (FEO2)

Using metabolic cart, fractional expired oxygen will be recorded.

Time frame: At first assessment, during week one.

Fractional expired oxygen (FEO2)

Using metabolic cart, fractional expired oxygen will be recorded.

Time frame: At second assessment, during week two.

Fractional expired oxygen (FEO2)

Using metabolic cart, fractional expired oxygen will be recorded.

Time frame: At third assessment, during week three.

Fractional expired carbon dioxide (FECO2)

Using metabolic cart, fractional expired carbon dioxide will be recorded.

Time frame: At first assessment, during week one.

Fractional expired carbon dioxide (FECO2)

Using metabolic cart, fractional expired carbon dioxide will be recorded.

Time frame: At second assessment during week two.

Fractional expired carbon dioxide (FECO2)

Using metabolic cart, fractional expired carbon dioxide will be recorded.

Time frame: At third assessment, during week three .