COSMED K5 Validation and Reliability Study

Study Overview
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Brief Summary
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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).

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

Conditions
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Cardiopulmonary, Exercise

Intervention / Treatment
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* Device: COSMED K5 CPET (Cardiopulmonary Exercise Test)
* Device: ParvoMedics CPET


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COSMED K5 CPET<br>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. | Device: COSMED K5 CPET (Cardiopulmonary Exercise Test)<br>* 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.<br>Device: ParvoMedics CPET<br>* ParvoMedics CPET<br>|
| Active Comparator: ParvoMedics CPET<br>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. | Device: COSMED K5 CPET (Cardiopulmonary Exercise Test)<br>* 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.<br>Device: ParvoMedics CPET<br>* ParvoMedics CPET<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen consumption (VO2), mL/min | Using metabolic cart, VO2 will be recorded. | At first assessment, during week one. | 
| Oxygen consumption (VO2), mL/min | Using metabolic cart, VO2 will be recorded. | At second assessment, during week two. | 
| Oxygen consumption (VO2), mL/min | Using metabolic cart, VO2 will be recorded. | At third assessment, during week three. | 
| Carbon dioxide production (VCO2), mL/min | Using metabolic cart, VCO2 will be recorded. | At first assessment, during week one. | 
| Carbon dioxide production (VCO2), mL/min | Using metabolic cart, VCO2 will be recorded. | At second assessment, during week two. | 
| Carbon dioxide production (VCO2), mL/min | Using metabolic cart, VCO2 will be recorded. | At third assessment, during week three. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Exchange Ratio (RER) | Using metabolic cart, respiratory exchange ratio will be recorded. | At first assessment, during week one. | 
| Respiratory Exchange Ratio (RER) | Using metabolic cart, respiratory exchange ratio will be recorded. | At second assessment, during week two. | 
| Respiratory Exchange Ratio (RER) | Using metabolic cart, respiratory exchange ratio will be recorded. | At third assessment, during week three. | 
| Minute Ventilation, L/min | Using metabolic cart, minute ventilation will be recorded. | At first assessment, during week one. | 
| Minute Ventilation, L/min | Using metabolic cart, minute ventilation will be recorded. | At second assessment, during week two. | 
| Minute Ventilation, L/min | Using metabolic cart, minute ventilation will be recorded. | At third assessment, during week three. | 
| Breathing Reserve, % | Using metabolic cart, breathing reserve will be recorded. | At first assessment, during week one. | 
| Breathing Reserve, % | Using metabolic cart, breathing reserve will be recorded. | At second assessment, during week two. | 
| Breathing Reserve, % | Using metabolic cart, breathing reserve will be recorded. | At third assessment, during week three. | 
| Tidal Volume, L | Using metabolic cart, tidal volume will be recorded. | At first assessment, during week one. | 
| Tidal Volume, L | Using metabolic cart, tidal volume will be recorded. | At second assessment, during week two. | 
| Tidal Volume, L | Using metabolic cart, tidal volume will be recorded. | At third assessment, during week three. | 
| Respiratory Frequency, /min | Using metabolic cart, respiratory frequency will be recorded. | At first assessment, during week one. | 
| Respiratory Frequency, /min | Using metabolic cart, respiratory frequency will be recorded. | At second assessment, during week two. | 
| Respiratory Frequency, /min | Using metabolic cart, respiratory frequency will be recorded. | At third assessment, during week three. | 
| Fractional expired oxygen (FEO2) | Using metabolic cart, fractional expired oxygen will be recorded. | At first assessment, during week one. | 
| Fractional expired oxygen (FEO2) | Using metabolic cart, fractional expired oxygen will be recorded. | At second assessment, during week two. | 
| Fractional expired oxygen (FEO2) | Using metabolic cart, fractional expired oxygen will be recorded. | At third assessment, during week three. | 
| Fractional expired carbon dioxide (FECO2) | Using metabolic cart, fractional expired carbon dioxide will be recorded. | At first assessment, during week one. | 
| Fractional expired carbon dioxide (FECO2) | Using metabolic cart, fractional expired carbon dioxide will be recorded. | At second assessment during week two. | 
| Fractional expired carbon dioxide (FECO2) | Using metabolic cart, fractional expired carbon dioxide will be recorded. | At third assessment, during week three . |