Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-02-27 @ 4:09 PM
Study NCT ID:
NCT04121351
Status:
TERMINATED
Last Update Posted:
2021-04-28
First Post:
2019-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiological Demands Related to Exercises in Singing for Lung Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-05-10', 'releaseDate': '2023-12-06'}, {'resetDate': '2024-10-16', 'releaseDate': '2024-07-02'}], 'estimatedResultsFirstSubmitDate': '2023-12-06'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'COVID-19 pandemic meant continuation of the study was unfeasible at this time.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2019-09-30', 'studyFirstSubmitQcDate': '2019-10-08', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen consumption in mL per kilogram per minute during different components of Singing for Lung Health(physical warm up, rhythm exercises, pitch exercises, vocal exercises, repertoire and relaxation)', 'timeFrame': 'Single assessment at baseline.', 'description': 'Assessed using portable metabolic measurement equipment (Oxycon Mobile made by Vyaire).'}], 'secondaryOutcomes': [{'measure': 'Heart rate during different components of Singing for Lung Health (physical warm up, rhythm exercises, pitch exercises, vocal exercises, repertoire and relaxation).', 'timeFrame': 'Single assessment at baseline.', 'description': 'Assessed using a portable heart rate monitor.'}, {'measure': 'Comparison of oxygen consumption, in mL per kilogram per minute, achieved during each component of Singing for Lung Health with walking at different speeds', 'timeFrame': 'Single assessment at baseline.', 'description': 'Oxygen consumption, in mL per kilogram per minute, will be assessed during different components of Singing for Lung Health(physical warm up, rhythm exercises, pitch exercises, vocal exercises, repertoire and relaxation. This will be compared with oxygen consumption while walking at three speeds on a treadmill (slow, medium and brisk). Oxygen consumption will be assessed using portable metabolic measurement equipment (Oxycon Mobile made by Vyaire).'}, {'measure': 'Movement intensity during different components of Singing for Lung Health(physical warm up, rhythm exercises, pitch exercises, vocal exercises, repertoire and relaxation).', 'timeFrame': 'Single assessment at baseline.', 'description': 'Assessed with the McRoberts fixed-body sensor MoveTest device.'}, {'measure': 'Changes in centre of mass during different components of Singing for Lung Health (physical warm up, rhythm exercises, pitch exercises, vocal exercises, repertoire and relaxation).', 'timeFrame': 'Single assessment at baseline', 'description': 'Assessed with the McRoberts fixed-body sensor MoveTest device.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung Health', 'Exercises'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '34045239', 'type': 'DERIVED', 'citation': 'Philip KE, Lewis A, Buttery SC, McCabe C, Manivannan B, Fancourt D, Orton CM, Polkey MI, Hopkinson NS. Physiological demands of singing for lung health compared with treadmill walking. BMJ Open Respir Res. 2021 May;8(1):e000959. doi: 10.1136/bmjresp-2021-000959.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the physiological demands related to Singing for Lung Health participation.', 'detailedDescription': 'This study will assess the physiological demands experienced by healthy volunteers participating in components of a Singing for Lung Health session. Oxygen consumption, heart rate, and fixed body sensor output puts related to balance and movement intensity will be assessed. The same parameters will also be assessed during walking on a treadmill at different speeds for comparison.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adults.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult\n* Able to undertake singing components\n* Able to undertake walking test\n* No contraindications to exercise\n* No contraindications to spirometry as per American Thoracic Society/European Respiratory Society criteria\n* Capacity to consent to exercise testing.\n\nExclusion Criteria:\n\n* Any health condition that would preclude them from singing or impede physical activity\n* Inability to comply or follow singing exercise instructions\n* Active musculoskeletal disease impairing exercise.'}, 'identificationModule': {'nctId': 'NCT04121351', 'acronym': 'PHRESH', 'briefTitle': 'Physiological Demands Related to Exercises in Singing for Lung Health', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Physiological Demands Related to Exercises in Singing for Lung Health: A Pilot Study (PHRESH Study)', 'orgStudyIdInfo': {'id': 'ICREC ref:19IC5429'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Singing participation', 'type': 'OTHER', 'description': 'Participants will follow a 15 minute protocol consisting of the components of a Singing for Lung Health class, and a short period walking on a treadmill.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW3 6NP', 'city': 'London', 'country': 'United Kingdom', 'facility': 'National Heart and Lung Institute, Imperial College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Keir Philip', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not currently decided.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-12-06', 'type': 'RELEASE'}, {'date': '2024-05-10', 'type': 'RESET'}, {'date': '2024-07-02', 'type': 'RELEASE'}, {'date': '2024-10-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Imperial College London'}}}}