Clinical trial NCT05145192: COSMED K5 Validation and Reliability Study
Official title: Validity and Reliability of the K5 Wearable Metabolic System During High-Intensity Treadmill Testing in Healthy, Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary
Exercise
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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).


Eligibility criteria: 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

Primary outcomes:
measure: Oxygen consumption (VO2), mL/min
timeFrame: At first assessment, during week one.
measure: Oxygen consumption (VO2), mL/min
timeFrame: At second assessment, during week two.
measure: Oxygen consumption (VO2), mL/min
timeFrame: At third assessment, during week three.
measure: Carbon dioxide production (VCO2), mL/min
timeFrame: At first assessment, during week one.
measure: Carbon dioxide production (VCO2), mL/min
timeFrame: At second assessment, during week two.
measure: Carbon dioxide production (VCO2), mL/min
timeFrame: At third assessment, during week three.
Secondary outcomes:
measure: Respiratory Exchange Ratio (RER)
timeFrame: At first assessment, during week one.
measure: Respiratory Exchange Ratio (RER)
timeFrame: At second assessment, during week two.
measure: Respiratory Exchange Ratio (RER)
timeFrame: At third assessment, during week three.
measure: Minute Ventilation, L/min
timeFrame: At first assessment, during week one.
measure: Minute Ventilation, L/min
timeFrame: At second assessment, during week two.
measure: Minute Ventilation, L/min
timeFrame: At third assessment, during week three.
measure: Breathing Reserve, %
timeFrame: At first assessment, during week one.
measure: Breathing Reserve, %
timeFrame: At second assessment, during week two.
measure: Breathing Reserve, %
timeFrame: At third assessment, during week three.
measure: Tidal Volume, L
timeFrame: At first assessment, during week one.
measure: Tidal Volume, L
timeFrame: At second assessment, during week two.
measure: Tidal Volume, L
timeFrame: At third assessment, during week three.
measure: Respiratory Frequency, /min
timeFrame: At first assessment, during week one.
measure: Respiratory Frequency, /min
timeFrame: At second assessment, during week two.
measure: Respiratory Frequency, /min
timeFrame: At third assessment, during week three.
measure: Fractional expired oxygen (FEO2)
timeFrame: At first assessment, during week one.
measure: Fractional expired oxygen (FEO2)
timeFrame: At second assessment, during week two.
measure: Fractional expired oxygen (FEO2)
timeFrame: At third assessment, during week three.
measure: Fractional expired carbon dioxide (FECO2)
timeFrame: At first assessment, during week one.
measure: Fractional expired carbon dioxide (FECO2)
timeFrame: At second assessment during week two.
measure: Fractional expired carbon dioxide (FECO2)
timeFrame: At third assessment, during week three .
Other outcomes:
Locations:
city: Frisco
country: United States
facility: Baylor Scott and White Sports Therapy and Research
state: Texas
Study officials:
References: