COSMED K5 Validation and Reliability Study (K5)

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

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 Overview

• Status: Completed
• Conditions: Exercise; Cardiopulmonary
• Intervention / Treatment: Device: COSMED K5 CPET (Cardiopulmonary Exercise Test); Device: ParvoMedics CPET

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Frisco, Texas, United States, 75034
      • Baylor Scott and White Sports Therapy and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 29 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COSMED K5 CPET; 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); 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
Active Comparator: ParvoMedics CPET; 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); 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

What is the study measuring?

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 .

Collaborators and Investigators

• Sponsor: Baylor Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Actual): October 10, 2023
• Study Completion (Actual): October 10, 2023

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: December 3, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 021-348

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No