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CardiopulmonaryK5NCT05145192

COSMED K5 Validation and Reliability Study

A study testing COSMED K5 CPET (Cardiopulmonary Exercise Test) and ParvoMedics CPET in people with Cardiopulmonary and Exercise, run by Baylor Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 29 yearsHealthy volunteers can take part
Conditions the study is for
Cardiopulmonary, Exercise
What is being tested?
COSMED K5 CPET (Cardiopulmonary Exercise Test) and ParvoMedics CPET
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
29 Nov 2021to 10 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 29 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 20-29 years of age

Who cannot join

  • 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
Show all 10Show fewer
  • Pacemakers/Implantable devices
  • Supplemental Oxygen use
  • Diagnosis of severe arterial hypertension
  • Uncontrolled asthma

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Baylor Scott and White Sports Therapy and Research

    Frisco, Texas, 75034

Other trials in United States

About this study

Official title: 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).

Being tested
COSMED K5 CPET (Cardiopulmonary Exercise Test), ParvoMedics CPET
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT05145192
Study groupRoleWhat they receive
COSMED K5 CPETExperimentalParticipants 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.
Receives: Device: COSMED K5 CPET (Cardiopulmonary Exercise Test); Device: ParvoMedics CPET
ParvoMedics CPETActive comparatorParticipants 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.
Receives: Device: COSMED K5 CPET (Cardiopulmonary Exercise Test); Device: ParvoMedics CPET

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oxygen consumption (VO2), mL/min

    Using metabolic cart, VO2 will be recorded.

    Measured: At first assessment, during week one.

  2. Oxygen consumption (VO2), mL/min

    Using metabolic cart, VO2 will be recorded.

    Measured: At second assessment, during week two.

  3. Oxygen consumption (VO2), mL/min

    Using metabolic cart, VO2 will be recorded.

    Measured: At third assessment, during week three.

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

    Using metabolic cart, VCO2 will be recorded.

    Measured: At first assessment, during week one.

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

    Using metabolic cart, VCO2 will be recorded.

    Measured: At second assessment, during week two.

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

    Using metabolic cart, VCO2 will be recorded.

    Measured: At third assessment, during week three.

Secondary outcomes (21)

  1. Respiratory Exchange Ratio (RER)

    Using metabolic cart, respiratory exchange ratio will be recorded.

    Measured: At first assessment, during week one.

  2. Respiratory Exchange Ratio (RER)

    Using metabolic cart, respiratory exchange ratio will be recorded.

    Measured: At second assessment, during week two.

  3. Respiratory Exchange Ratio (RER)

    Using metabolic cart, respiratory exchange ratio will be recorded.

    Measured: At third assessment, during week three.

  4. Minute Ventilation, L/min

    Using metabolic cart, minute ventilation will be recorded.

    Measured: At first assessment, during week one.

  5. Minute Ventilation, L/min

    Using metabolic cart, minute ventilation will be recorded.

    Measured: At second assessment, during week two.

  6. Minute Ventilation, L/min

    Using metabolic cart, minute ventilation will be recorded.

    Measured: At third assessment, during week three.

  7. Breathing Reserve, %

    Using metabolic cart, breathing reserve will be recorded.

    Measured: At first assessment, during week one.

  8. Breathing Reserve, %

    Using metabolic cart, breathing reserve will be recorded.

    Measured: At second assessment, during week two.

  9. Breathing Reserve, %

    Using metabolic cart, breathing reserve will be recorded.

    Measured: At third assessment, during week three.

  10. Tidal Volume, L

    Using metabolic cart, tidal volume will be recorded.

    Measured: At first assessment, during week one.

  11. Tidal Volume, L

    Using metabolic cart, tidal volume will be recorded.

    Measured: At second assessment, during week two.

  12. Tidal Volume, L

    Using metabolic cart, tidal volume will be recorded.

    Measured: At third assessment, during week three.

  13. Respiratory Frequency, /min

    Using metabolic cart, respiratory frequency will be recorded.

    Measured: At first assessment, during week one.

  14. Respiratory Frequency, /min

    Using metabolic cart, respiratory frequency will be recorded.

    Measured: At second assessment, during week two.

  15. Respiratory Frequency, /min

    Using metabolic cart, respiratory frequency will be recorded.

    Measured: At third assessment, during week three.

  16. Fractional expired oxygen (FEO2)

    Using metabolic cart, fractional expired oxygen will be recorded.

    Measured: At first assessment, during week one.

  17. Fractional expired oxygen (FEO2)

    Using metabolic cart, fractional expired oxygen will be recorded.

    Measured: At second assessment, during week two.

  18. Fractional expired oxygen (FEO2)

    Using metabolic cart, fractional expired oxygen will be recorded.

    Measured: At third assessment, during week three.

  19. Fractional expired carbon dioxide (FECO2)

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

    Measured: At first assessment, during week one.

  20. Fractional expired carbon dioxide (FECO2)

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

    Measured: At second assessment during week two.

  21. Fractional expired carbon dioxide (FECO2)

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

    Measured: At third assessment, during week three .

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2021
  2. Study start29 Nov 2021
  3. Primary completion10 Oct 2023
  4. Study completion10 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05145192
Sponsor's protocol ID
021-348
Acronym
K5
Status last verified
Oct 2024
First submitted
17 Nov 2021
Last updated
22 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing COSMED K5 CPET (Cardiopulmonary Exercise Test) and ParvoMedics CPET in people with Cardiopulmonary and Exercise, run by Baylor Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxygen consumption (VO2), mL/min (time frame: At first assessment, during week one.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05145192.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.

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