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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05145192
Other study ID # 021-348
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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 .
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