COSMED K5 Validation and Reliability Study

NCT05145192 | Completed FDA Device

• 1 other identifier: 021-348
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiopulmonary; Exercise

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (21)

• Respiratory Exchange Ratio (RER)

  At first assessment, during week one.

• Respiratory Exchange Ratio (RER)

  At second assessment, during week two.

• Respiratory Exchange Ratio (RER)

  At third assessment, during week three.

• Minute Ventilation, L/min

  At first assessment, during week one.

• Minute Ventilation, L/min

  At second assessment, during week two.

Study Arms (2)

COSMED K5 CPET

EXPERIMENTAL

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); Device: ParvoMedics CPET

ParvoMedics CPET

ACTIVE COMPARATOR

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); Device: ParvoMedics CPET

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.

COSMED K5 CPET; ParvoMedics CPET

ParvoMedics CPET DEVICE

ParvoMedics CPET

COSMED K5 CPET; ParvoMedics CPET

Eligibility Criteria

• Age: 20 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott and White Sports Therapy and Research

Frisco, Texas, 75034, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Center Director - The STAR at Frisco

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 6, 2021
• Study Start: November 29, 2021
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: January 22, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)