Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-01 @ 10:15 PM
Study NCT ID:
NCT04963504
Status:
COMPLETED
Last Update Posted:
2021-11-10
First Post:
2021-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Diffusing Capacity During Postural Postural Changes and Acute Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-09', 'studyFirstSubmitDate': '2021-07-05', 'studyFirstSubmitQcDate': '2021-07-14', 'lastUpdatePostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Between day DLNO/DLCO-ratio repeatability coefficient', 'timeFrame': '1 week', 'description': 'Between-day repeatability coefficient of DLNO/DLCO at rest in both groups combined'}, {'measure': 'Between day DLCO repeatability coefficient', 'timeFrame': '1 week', 'description': 'Between-day repeatability coefficient of DLCO at rest in both groups combined'}, {'measure': 'Between day DLNO repeatability coefficient', 'timeFrame': '1 week', 'description': 'Between-day repeatability coefficient of DLNO at rest in both groups combined'}, {'measure': 'Between day DM repeatability coefficient', 'timeFrame': '1 week', 'description': 'Between-day repeatability coefficient of DM at rest in both groups combined'}, {'measure': 'Between day Vc repeatability coefficient', 'timeFrame': '1 week', 'description': 'Between-day repeatability coefficient of Vc at rest in both groups combined'}, {'measure': 'DLNO/DLCO-ratio MDC', 'timeFrame': '1 week', 'description': 'Between-day MDC of DLNO/DLCO from rest-to-exercise and supine-to-prone'}, {'measure': 'DLCO MDC', 'timeFrame': '1 week', 'description': 'Between-day MDC of DLCO from rest-to-exercise and supine-to-prone'}, {'measure': 'DLNO MDC', 'timeFrame': '1 week', 'description': 'Between-day MDC of DLNO from rest-to-exercise and supine-to-prone'}, {'measure': 'DM MDC', 'timeFrame': '1 week', 'description': 'Between-day MDC of DM from rest-to-exercise and supine-to-prone'}, {'measure': 'Vc MDC', 'timeFrame': '1 week', 'description': 'Between-day Vc of DM from rest-to-exercise and supine-to-prone'}, {'measure': 'DLNO/DLCO-ratio ICC', 'timeFrame': '1 week', 'description': 'Between-day ICC of DLNO/DLCO from rest-to-exercise and supine-to-prone'}, {'measure': 'DLCO ICC', 'timeFrame': '1 week', 'description': 'Between-day ICC of DLCO from rest-to-exercise and supine-to-prone'}, {'measure': 'DLNO ICC', 'timeFrame': '1 week', 'description': 'Between-day ICC of DLNO from rest-to-exercise and supine-to-prone'}, {'measure': 'DM ICC', 'timeFrame': '1 week', 'description': 'Between-day ICC of DM from rest-to-exercise and supine-to-prone'}, {'measure': 'Vc ICC', 'timeFrame': '1 week', 'description': 'Between-day ICC of Vc from rest-to-exercise and supine-to-prone'}, {'measure': 'DLNO/DLCO-ratio SEM', 'timeFrame': '1 week', 'description': 'Between-day SEM of DLNO/DLCO from rest-to-exercise and supine-to-prone'}, {'measure': 'DLCO SEM', 'timeFrame': '1 week', 'description': 'Between-day SEM of DLCO from rest-to-exercise and supine-to-prone'}, {'measure': 'DLNO SEM', 'timeFrame': '1 week', 'description': 'Between-day SEM of DLNO from rest-to-exercise and supine-to-prone'}, {'measure': 'DM SEM', 'timeFrame': '1 week', 'description': 'Between-day SEM of DM from rest-to-exercise and supine-to-prone'}, {'measure': 'Vc SEM', 'timeFrame': '1 week', 'description': 'Between-day SEM of Vc from rest-to-exercise and supine-to-prone'}, {'measure': 'DLNO/DLCO-ratio CV', 'timeFrame': '1 week', 'description': 'Between-day CV of DLNO/DLCO from rest-to-exercise and supine-to-prone'}, {'measure': 'DLCO CV', 'timeFrame': '1 week', 'description': 'Between-day CV of DLCO from rest-to-exercise and supine-to-prone'}, {'measure': 'DLNO CV', 'timeFrame': '1 week', 'description': 'Between-day CV of DLNO from rest-to-exercise and supine-to-prone'}, {'measure': 'DM CV', 'timeFrame': '1 week', 'description': 'Between-day CV of DM from rest-to-exercise and supine-to-prone'}, {'measure': 'Vc CV', 'timeFrame': '1 week', 'description': 'Between-day CV of Vc from rest-to-exercise and supine-to-prone'}], 'primaryOutcomes': [{'measure': 'Between intervention DLNO/DLCO-ratio repeatability coefficient', 'timeFrame': '1 week', 'description': 'Test-retest reliability coefficient of rest-to-exercise and supine-to-prone DLNO/DLCO-ratio'}, {'measure': 'Between intervention DLCO repeatability coefficient', 'timeFrame': '1 week', 'description': 'Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone DLCO'}, {'measure': 'Between intervention DLNO repeatability coefficient', 'timeFrame': '1 week', 'description': 'Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone DLNO'}], 'secondaryOutcomes': [{'measure': 'Between intervention DM repeatability coefficient', 'timeFrame': '1 week', 'description': 'Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone DM'}, {'measure': 'Between intervention Vc repeatability coefficient', 'timeFrame': '1 week', 'description': 'Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone Vc'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clinical Assessments of Pulmonary Diffusing Capacity']}, 'descriptionModule': {'briefSummary': 'The combined measurement of the pulmonary diffusing capacity to carbon monoxide (CO) and nitric oxide (NO) (DLCO/NO) has recently been standardised and validated for clinical use. It involves a very short breath-hold time (≤5 seconds), and it may be repeated up to 12 times without affecting measurements, and it is thus ideal for assessing acute changes in pulmonary diffusing capacity and its components during various physiological manoeuvres. The aim of the present study is to compare the test-retest reliability of pulmonary diffusing capacity measurements during postural changes (sitting vs. supine) vs. rest-to-exercise. DLCO/NO will either be measured in the sitting position during rest vs. exercise or in the sitting and supine posture, and this will be repeated within 1-7 days in 20 healthy individuals that will be randomised to one of the two interventions. Statistically,the test-retest relaibility of sitting-to-supine vs. rest-to-exercise changes in DLCO/NO will be compared by parametric methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Regular exercise (1-3 timer per week)\n\nExclusion Criteria:\n\n* Any known medical condition that requires regular medication or any known lung condition\n* Smoking\n* Symptoms of disease within 2 weeks prior to the study\n* Abnormal lung function test\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04963504', 'acronym': 'DiffLung', 'briefTitle': 'Pulmonary Diffusing Capacity During Postural Postural Changes and Acute Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Pulmonary Diffusing Capacity Changes to Posture and Acute Exercise in Healthy Volunteers: a Randomised Test-retest Relaibility Study', 'orgStudyIdInfo': {'id': 'KF_458_21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rest-to-exercise', 'interventionNames': ['Diagnostic Test: Rest-to-exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Sitting-to-supine', 'interventionNames': ['Diagnostic Test: Sitting-to-supine']}], 'interventions': [{'name': 'Rest-to-exercise', 'type': 'DIAGNOSTIC_TEST', 'description': 'Pulmonary diffusing capacity is assessed at rest and during exercise (70% of VO2max on a bicycle ergometer)', 'armGroupLabels': ['Rest-to-exercise']}, {'name': 'Sitting-to-supine', 'type': 'DIAGNOSTIC_TEST', 'description': 'Pulmonary diffusing capacity is assessed in the sitting and supine position', 'armGroupLabels': ['Sitting-to-supine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Ronan Berg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be shared upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ronan Berg', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}