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Completed

NCT Number: NCT05145192

COSMED K5 Validation and Reliability Study

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).

Completed

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Key information

Conditions

Cardiopulmonary Behavior Exercise Motor Activity

Age range

20 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Scott and White Sports Therapy and Research

Frisco, Texas, 75034, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 CPET

Device

ParvoMedics CPET

Primary outcomes

  1. Oxygen consumption (VO2), mL/min

    Time frame: At first assessment, during week one.

    Using metabolic cart, VO2 will be recorded.

  2. Oxygen consumption (VO2), mL/min

    Time frame: At second assessment, during week two.

    Using metabolic cart, VO2 will be recorded.

  3. Oxygen consumption (VO2), mL/min

    Time frame: At third assessment, during week three.

    Using metabolic cart, VO2 will be recorded.

  4. Carbon dioxide production (VCO2), mL/min

    Time frame: At first assessment, during week one.

    Using metabolic cart, VCO2 will be recorded.

  5. Carbon dioxide production (VCO2), mL/min

    Time frame: At second assessment, during week two.

    Using metabolic cart, VCO2 will be recorded.

  6. Carbon dioxide production (VCO2), mL/min

    Time frame: At third assessment, during week three.

    Using metabolic cart, VCO2 will be recorded.

Secondary outcomes

  1. Respiratory Exchange Ratio (RER)

    Time frame: At first assessment, during week one.

    Using metabolic cart, respiratory exchange ratio will be recorded.

  2. Respiratory Exchange Ratio (RER)

    Time frame: At second assessment, during week two.

    Using metabolic cart, respiratory exchange ratio will be recorded.

  3. Respiratory Exchange Ratio (RER)

    Time frame: At third assessment, during week three.

    Using metabolic cart, respiratory exchange ratio will be recorded.

  4. Minute Ventilation, L/min

    Time frame: At first assessment, during week one.

    Using metabolic cart, minute ventilation will be recorded.

  5. Minute Ventilation, L/min

    Time frame: At second assessment, during week two.

    Using metabolic cart, minute ventilation will be recorded.

  6. Minute Ventilation, L/min

    Time frame: At third assessment, during week three.

    Using metabolic cart, minute ventilation will be recorded.

  7. Breathing Reserve, %

    Time frame: At first assessment, during week one.

    Using metabolic cart, breathing reserve will be recorded.

  8. Breathing Reserve, %

    Time frame: At second assessment, during week two.

    Using metabolic cart, breathing reserve will be recorded.

  9. Breathing Reserve, %

    Time frame: At third assessment, during week three.

    Using metabolic cart, breathing reserve will be recorded.

  10. Tidal Volume, L

    Time frame: At first assessment, during week one.

    Using metabolic cart, tidal volume will be recorded.

  11. Tidal Volume, L

    Time frame: At second assessment, during week two.

    Using metabolic cart, tidal volume will be recorded.

  12. Tidal Volume, L

    Time frame: At third assessment, during week three.

    Using metabolic cart, tidal volume will be recorded.

  13. Respiratory Frequency, /min

    Time frame: At first assessment, during week one.

    Using metabolic cart, respiratory frequency will be recorded.

  14. Respiratory Frequency, /min

    Time frame: At second assessment, during week two.

    Using metabolic cart, respiratory frequency will be recorded.

  15. Respiratory Frequency, /min

    Time frame: At third assessment, during week three.

    Using metabolic cart, respiratory frequency will be recorded.

  16. Fractional expired oxygen (FEO2)

    Time frame: At first assessment, during week one.

    Using metabolic cart, fractional expired oxygen will be recorded.

  17. Fractional expired oxygen (FEO2)

    Time frame: At second assessment, during week two.

    Using metabolic cart, fractional expired oxygen will be recorded.

  18. Fractional expired oxygen (FEO2)

    Time frame: At third assessment, during week three.

    Using metabolic cart, fractional expired oxygen will be recorded.

  19. Fractional expired carbon dioxide (FECO2)

    Time frame: At first assessment, during week one.

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

  20. Fractional expired carbon dioxide (FECO2)

    Time frame: At second assessment during week two.

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

  21. Fractional expired carbon dioxide (FECO2)

    Time frame: At third assessment, during week three .

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

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

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

Acronym: K5

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 6, 2021
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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