Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-28 @ 9:23 PM
Study NCT ID:
NCT05145192
Status:
COMPLETED
Last Update Posted:
2025-01-22
First Post:
2021-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COSMED K5 Validation and Reliability Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-10-27', 'mcpReleaseN': 4, 'releaseDate': '2025-10-01'}], 'estimatedResultsFirstSubmitDate': '2025-10-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-20', 'studyFirstSubmitDate': '2021-11-17', 'studyFirstSubmitQcDate': '2021-12-03', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen consumption (VO2), mL/min', 'timeFrame': 'At first assessment, during week one.', 'description': 'Using metabolic cart, VO2 will be recorded.'}, {'measure': 'Oxygen consumption (VO2), mL/min', 'timeFrame': 'At second assessment, during week two.', 'description': 'Using metabolic cart, VO2 will be recorded.'}, {'measure': 'Oxygen consumption (VO2), mL/min', 'timeFrame': 'At third assessment, during week three.', 'description': 'Using metabolic cart, VO2 will be recorded.'}, {'measure': 'Carbon dioxide production (VCO2), mL/min', 'timeFrame': 'At first assessment, during week one.', 'description': 'Using metabolic cart, VCO2 will be recorded.'}, {'measure': 'Carbon dioxide production (VCO2), mL/min', 'timeFrame': 'At second assessment, during week two.', 'description': 'Using metabolic cart, VCO2 will be recorded.'}, {'measure': 'Carbon dioxide production (VCO2), mL/min', 'timeFrame': 'At third assessment, during week three.', 'description': 'Using metabolic cart, VCO2 will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Respiratory Exchange Ratio (RER)', 'timeFrame': 'At first assessment, during week one.', 'description': 'Using metabolic cart, respiratory exchange ratio will be recorded.'}, {'measure': 'Respiratory Exchange Ratio (RER)', 'timeFrame': 'At second assessment, during week two.', 'description': 'Using metabolic cart, respiratory exchange ratio will be recorded.'}, {'measure': 'Respiratory Exchange Ratio (RER)', 'timeFrame': 'At third assessment, during week three.', 'description': 'Using metabolic cart, respiratory exchange ratio will be recorded.'}, {'measure': 'Minute Ventilation, L/min', 'timeFrame': 'At first assessment, during week one.', 'description': 'Using metabolic cart, minute ventilation will be recorded.'}, {'measure': 'Minute Ventilation, L/min', 'timeFrame': 'At second assessment, during week two.', 'description': 'Using metabolic cart, minute ventilation will be recorded.'}, {'measure': 'Minute Ventilation, L/min', 'timeFrame': 'At third assessment, during week three.', 'description': 'Using metabolic cart, minute ventilation will be recorded.'}, {'measure': 'Breathing Reserve, %', 'timeFrame': 'At first assessment, during week one.', 'description': 'Using metabolic cart, breathing reserve will be recorded.'}, {'measure': 'Breathing Reserve, %', 'timeFrame': 'At second assessment, during week two.', 'description': 'Using metabolic cart, breathing reserve will be recorded.'}, {'measure': 'Breathing Reserve, %', 'timeFrame': 'At third assessment, during week three.', 'description': 'Using metabolic cart, breathing reserve will be recorded.'}, {'measure': 'Tidal Volume, L', 'timeFrame': 'At first assessment, during week one.', 'description': 'Using metabolic cart, tidal volume will be recorded.'}, {'measure': 'Tidal Volume, L', 'timeFrame': 'At second assessment, during week two.', 'description': 'Using metabolic cart, tidal volume will be recorded.'}, {'measure': 'Tidal Volume, L', 'timeFrame': 'At third assessment, during week three.', 'description': 'Using metabolic cart, tidal volume will be recorded.'}, {'measure': 'Respiratory Frequency, /min', 'timeFrame': 'At first assessment, during week one.', 'description': 'Using metabolic cart, respiratory frequency will be recorded.'}, {'measure': 'Respiratory Frequency, /min', 'timeFrame': 'At second assessment, during week two.', 'description': 'Using metabolic cart, respiratory frequency will be recorded.'}, {'measure': 'Respiratory Frequency, /min', 'timeFrame': 'At third assessment, during week three.', 'description': 'Using metabolic cart, respiratory frequency will be recorded.'}, {'measure': 'Fractional expired oxygen (FEO2)', 'timeFrame': 'At first assessment, during week one.', 'description': 'Using metabolic cart, fractional expired oxygen will be recorded.'}, {'measure': 'Fractional expired oxygen (FEO2)', 'timeFrame': 'At second assessment, during week two.', 'description': 'Using metabolic cart, fractional expired oxygen will be recorded.'}, {'measure': 'Fractional expired oxygen (FEO2)', 'timeFrame': 'At third assessment, during week three.', 'description': 'Using metabolic cart, fractional expired oxygen will be recorded.'}, {'measure': 'Fractional expired carbon dioxide (FECO2)', 'timeFrame': 'At first assessment, during week one.', 'description': 'Using metabolic cart, fractional expired carbon dioxide will be recorded.'}, {'measure': 'Fractional expired carbon dioxide (FECO2)', 'timeFrame': 'At second assessment during week two.', 'description': 'Using metabolic cart, fractional expired carbon dioxide will be recorded.'}, {'measure': 'Fractional expired carbon dioxide (FECO2)', 'timeFrame': 'At third assessment, during week three .', 'description': 'Using metabolic cart, fractional expired carbon dioxide will be recorded.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cardiopulmonary', 'Exercise']}, 'descriptionModule': {'briefSummary': '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.\n\nTo determine the test-retest reliability of the K5 metabolic system breath-by-breath analyzer during a high intensity treadmill protocol (Bruce Protocol).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20-29 years of age\n\nExclusion Criteria:\n\n* Pregnancy\n* Children\n* Inmates\n* Neuromotor, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise or conditions preventing cooperation\n* Contraindications to Symptom-limited Maximal Exercise Testing\n* Metabolic disease\n* Pacemakers/Implantable devices\n* Supplemental Oxygen use\n* Diagnosis of severe arterial hypertension\n* Uncontrolled asthma'}, 'identificationModule': {'nctId': 'NCT05145192', 'acronym': 'K5', 'briefTitle': 'COSMED K5 Validation and Reliability Study', 'organization': {'class': 'OTHER', 'fullName': 'Baylor Research Institute'}, 'officialTitle': 'Validity and Reliability of the K5 Wearable Metabolic System During High-Intensity Treadmill Testing in Healthy, Young Adults', 'orgStudyIdInfo': {'id': '021-348'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COSMED K5 CPET', 'description': '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.', 'interventionNames': ['Device: COSMED K5 CPET (Cardiopulmonary Exercise Test)', 'Device: ParvoMedics CPET']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ParvoMedics CPET', 'description': '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.', 'interventionNames': ['Device: COSMED K5 CPET (Cardiopulmonary Exercise Test)', 'Device: ParvoMedics CPET']}], 'interventions': [{'name': 'COSMED K5 CPET (Cardiopulmonary Exercise Test)', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['COSMED K5 CPET', 'ParvoMedics CPET']}, {'name': 'ParvoMedics CPET', 'type': 'DEVICE', 'description': 'ParvoMedics CPET', 'armGroupLabels': ['COSMED K5 CPET', 'ParvoMedics CPET']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75034', 'city': 'Frisco', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott and White Sports Therapy and Research', 'geoPoint': {'lat': 33.15067, 'lon': -96.82361}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Center Director - The STAR at Frisco', 'investigatorFullName': 'Simon Driver', 'investigatorAffiliation': 'Baylor Research Institute'}}}}