Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT04618302
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2020-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lung Diffusing Capacity for Nitric Oxide During Cycling Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-15', 'studyFirstSubmitDate': '2020-10-28', 'studyFirstSubmitQcDate': '2020-11-04', 'lastUpdatePostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diffusing capacity for nitric oxide (DLNO)', 'timeFrame': 'At second study visit', 'description': 'DLNO (in ml/min/mmHg) measured at 80% of the gas exchange threshold during cycling exercise.'}, {'measure': 'Diffusing capacity for nitric oxide (DLNO)', 'timeFrame': 'At third study visit, approximately 1-2 weeks after second study visit', 'description': 'DLNO (in ml/min/mmHg) measured at 80% of the gas exchange threshold during cycling exercise.'}], 'secondaryOutcomes': [{'measure': 'Diffusing capacity for nitric oxide (DLNO)', 'timeFrame': 'At second study visit', 'description': 'DLNO (in ml/min/mmHg) measured at 50% of the gas exchange threshold during cycling exercise.'}, {'measure': 'Diffusing capacity for nitric oxide (DLNO)', 'timeFrame': 'At third study visit, approximately 1-2 weeks after second study visit', 'description': 'DLNO (in ml/min/mmHg) measured at 50% of the gas exchange threshold during cycling exercise.'}, {'measure': 'Diffusing capacity for carbon monoxide (DLCO)', 'timeFrame': 'At second study visit', 'description': 'DLCO (in ml/min/mmHg) measured at 50% of the gas exchange threshold during cycling exercise.'}, {'measure': 'Diffusing capacity for carbon monoxide (DLCO)', 'timeFrame': 'At third study visit, approximately 1-2 weeks after second study visit', 'description': 'DLCO (in ml/min/mmHg) measured at 50% of the gas exchange threshold during cycling exercise.'}, {'measure': 'Diffusing capacity for carbon monoxide (DLCO)', 'timeFrame': 'At second study visit', 'description': 'Agreement in DLCO (in ml/min/mmHg) measured at 80% of the gas exchange threshold during cycling exercise.'}, {'measure': 'Diffusing capacity for carbon monoxide (DLCO)', 'timeFrame': 'At third study visit, approximately 1-2 weeks after second study visit', 'description': 'Agreement in DLCO (in ml/min/mmHg) measured at 80% of the gas exchange threshold during cycling exercise.'}, {'measure': 'Alveolar volume (VA)', 'timeFrame': 'At second study visit', 'description': 'VA (in L) measured at 50% of the gas exchange threshold during cycling exercise.'}, {'measure': 'Alveolar volume (VA)', 'timeFrame': 'At third study visit, approximately 1-2 weeks after second study visit', 'description': 'VA (in L) measured at 50% of the gas exchange threshold during cycling exercise.'}, {'measure': 'Alveolar volume (VA)', 'timeFrame': 'At second study visit', 'description': 'Alveolar volume (in L) measured at 80% of the gas exchange threshold during cycling exercise.'}, {'measure': 'Alveolar volume (VA)', 'timeFrame': 'At third study visit, approximately 1-2 weeks after second study visit', 'description': 'Alveolar volume (in L) measured at 80% of the gas exchange threshold during cycling exercise.'}, {'measure': 'Breath hold time (BHT)', 'timeFrame': 'At second study visit', 'description': 'BHT (in s) measured at 80% of the gas exchange threshold during cycling exercise.'}, {'measure': 'Breath hold time (BHT)', 'timeFrame': 'At third study visit, approximately 1-2 weeks after second study visit', 'description': 'BHT (in s) measured at 80% of the gas exchange threshold during cycling exercise.'}, {'measure': 'Breath hold time (BHT)', 'timeFrame': 'At second study visit', 'description': 'BHT (in s) measured at 50% of the gas exchange threshold during cycling exercise.'}, {'measure': 'Breath hold time (BHT)', 'timeFrame': 'At third study visit, approximately 1-2 weeks after second study visit', 'description': 'BHT (in s) measured at 50% of the gas exchange threshold during cycling exercise.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lung diffusing capacity for nitric oxide', 'lung function testing'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study investigates the test-retest reliability of the lung diffusing capacity for nitric oxide in healthy individuals during exercise.', 'detailedDescription': 'The aim of this study of to evaluate the test-retest reliability of single-breath lung diffusing capacity measurements for nitric oxide (DLNO) in healthy individuals during light and moderate intensity cycling exercise. Healthy subjects will perform repeated single-breath DLNO measurements during light (i.e., at 50% of the first ventilatory threshold) and moderate intensity exercise (i.e., 80% of the first ventilatory threshold) on a stationary cycle ergometer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy people without chronic cardiopulmonary diseases will be invited to participate in this study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Age 18 yrs and older\n* Ability to follow study procedures and instructions in German\n\nExclusion Criteria:\n\n* Any known cardiopulmonary or metabolic diseases (e.g., heart disease, diabetes mellitus etc)\n* Obesity (BMI \\> 30kg/m2)\n* Smoking (ex-smoker allowed; if they stopped smoking at least one year before the examination)\n* Mental impairment leading to inability to cooperate\n* Respiratory infection in the last two weeks\n* Forced expiratory volume in 1s/ forced vital capacity (FEV1/FVC ratio) FEV1/FVC ratio \\< lower limit of normal according to equations by Quanjer et al. Eur Respir J 2012.'}, 'identificationModule': {'nctId': 'NCT04618302', 'briefTitle': 'Lung Diffusing Capacity for Nitric Oxide During Cycling Exercise', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Test-retest Reliability of Lung Diffusing Capacity for Nitric Oxide During Light and Moderate Intensity Cycling Exercise', 'orgStudyIdInfo': {'id': '2020-01756'}}, 'contactsLocationsModule': {'locations': [{'zip': '8001', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University of Zurich and University Hospital of Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Thomas Radtke, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich and University Hospital Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Radtke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PD Dr phil Thomas Radtke', 'investigatorFullName': 'Thomas Radtke', 'investigatorAffiliation': 'University of Zurich'}}}}