COSMED K5 Validation and Reliability Study

Exercise Clinical Trial

— K5  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05145192
• Other study ID #: 021-348
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: June 2023
• Source: Baylor Research Institute
• Contact: Taylor Gilliland, MS
• Phone: 214-603-1527
• Email: taylor.gilliland[@]bswhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. To determine the test-retest reliability of the K5 metabolic system breath-by-breath analyzer during a high intensity treadmill protocol (Bruce Protocol).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiopulmonary
• Exercise

Intervention

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.
• ParvoMedics CPET
ParvoMedics CPET

Locations

Country	Name	City	State
United States	Baylor Scott and White Sports Therapy and Research	Frisco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen consumption (VO2), mL/min	Using metabolic cart, VO2 will be recorded.	At first assessment, during week one.
Primary	Oxygen consumption (VO2), mL/min	Using metabolic cart, VO2 will be recorded.	At second assessment, during week two.
Primary	Oxygen consumption (VO2), mL/min	Using metabolic cart, VO2 will be recorded.	At third assessment, during week three.
Primary	Carbon dioxide production (VCO2), mL/min	Using metabolic cart, VCO2 will be recorded.	At first assessment, during week one.
Primary	Carbon dioxide production (VCO2), mL/min	Using metabolic cart, VCO2 will be recorded.	At second assessment, during week two.
Primary	Carbon dioxide production (VCO2), mL/min	Using metabolic cart, VCO2 will be recorded.	At third assessment, during week three.
Secondary	Respiratory Exchange Ratio (RER)	Using metabolic cart, respiratory exchange ratio will be recorded.	At first assessment, during week one.
Secondary	Respiratory Exchange Ratio (RER)	Using metabolic cart, respiratory exchange ratio will be recorded.	At second assessment, during week two.
Secondary	Respiratory Exchange Ratio (RER)	Using metabolic cart, respiratory exchange ratio will be recorded.	At third assessment, during week three.
Secondary	Minute Ventilation, L/min	Using metabolic cart, minute ventilation will be recorded.	At first assessment, during week one.
Secondary	Minute Ventilation, L/min	Using metabolic cart, minute ventilation will be recorded.	At second assessment, during week two.
Secondary	Minute Ventilation, L/min	Using metabolic cart, minute ventilation will be recorded.	At third assessment, during week three.
Secondary	Breathing Reserve, %	Using metabolic cart, breathing reserve will be recorded.	At first assessment, during week one.
Secondary	Breathing Reserve, %	Using metabolic cart, breathing reserve will be recorded.	At second assessment, during week two.
Secondary	Breathing Reserve, %	Using metabolic cart, breathing reserve will be recorded.	At third assessment, during week three.
Secondary	Tidal Volume, L	Using metabolic cart, tidal volume will be recorded.	At first assessment, during week one.
Secondary	Tidal Volume, L	Using metabolic cart, tidal volume will be recorded.	At second assessment, during week two.
Secondary	Tidal Volume, L	Using metabolic cart, tidal volume will be recorded.	At third assessment, during week three.
Secondary	Respiratory Frequency, /min	Using metabolic cart, respiratory frequency will be recorded.	At first assessment, during week one.
Secondary	Respiratory Frequency, /min	Using metabolic cart, respiratory frequency will be recorded.	At second assessment, during week two.
Secondary	Respiratory Frequency, /min	Using metabolic cart, respiratory frequency will be recorded.	At third assessment, during week three.
Secondary	Fractional expired oxygen (FEO2)	Using metabolic cart, fractional expired oxygen will be recorded.	At first assessment, during week one.
Secondary	Fractional expired oxygen (FEO2)	Using metabolic cart, fractional expired oxygen will be recorded.	At second assessment, during week two.
Secondary	Fractional expired oxygen (FEO2)	Using metabolic cart, fractional expired oxygen will be recorded.	At third assessment, during week three.
Secondary	Fractional expired carbon dioxide (FECO2)	Using metabolic cart, fractional expired carbon dioxide will be recorded.	At first assessment, during week one.
Secondary	Fractional expired carbon dioxide (FECO2)	Using metabolic cart, fractional expired carbon dioxide will be recorded.	At second assessment during week two.
Secondary	Fractional expired carbon dioxide (FECO2)	Using metabolic cart, fractional expired carbon dioxide will be recorded.	At third assessment, during week three .