COSMED K5 Validation and Reliability Study

Not Applicable

Completed

• Conditions: Cardiopulmonary; Exercise
• Interventions: Device: COSMED K5 CPET (Cardiopulmonary Exercise Test); Device: ParvoMedics CPET

• Registration Number: NCT05145192
• Lead Sponsor: Baylor Research Institute

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-17
• Study Start: 2021-11-29
• Study First Submitted QC: 2021-12-03
• Study First Posted: 2021-12-06
• Primary Completion: 2023-10-10
• Study Completion: 2023-10-10
• Status Verified: 2024-10
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
COSMED K5 CPET	COSMED K5 CPET (Cardiopulmonary Exercise Test)	Participants 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.
ParvoMedics CPET	COSMED K5 CPET (Cardiopulmonary Exercise Test)	Participants 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.
ParvoMedics CPET	ParvoMedics CPET	Participants 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.
COSMED K5 CPET	ParvoMedics CPET	Participants 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.

Primary Outcome Measures

Name	Time	Method
Oxygen consumption (VO2), mL/min	At third assessment, during week three.	Using metabolic cart, VO2 will be recorded.
Carbon dioxide production (VCO2), mL/min	At third assessment, during week three.	Using metabolic cart, VCO2 will be recorded.

Secondary Outcome Measures

Name	Time	Method
Respiratory Exchange Ratio (RER)	At third assessment, during week three.	Using metabolic cart, respiratory exchange ratio will be recorded.
Fractional expired carbon dioxide (FECO2)	At third assessment, during week three .	Using metabolic cart, fractional expired carbon dioxide will be recorded.
Minute Ventilation, L/min	At third assessment, during week three.	Using metabolic cart, minute ventilation will be recorded.
Fractional expired oxygen (FEO2)	At third assessment, during week three.	Using metabolic cart, fractional expired oxygen will be recorded.
Breathing Reserve, %	At third assessment, during week three.	Using metabolic cart, breathing reserve will be recorded.
Tidal Volume, L	At third assessment, during week three.	Using metabolic cart, tidal volume will be recorded.
Respiratory Frequency, /min	At third assessment, during week three.	Using metabolic cart, respiratory frequency will be recorded.

Trial Locations

Locations (1)

Baylor Scott and White Sports Therapy and Research; 🇺🇸 Frisco, Texas, United States