Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT04557605
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2020-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of a Face Mask on Oxygenation During Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The individual who will statistically analyze the data will be blinded to condition'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-16', 'studyFirstSubmitDate': '2020-09-09', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to exhaustion during exercise', 'timeFrame': 'Up to 20 minutes', 'description': 'time to exhaustion'}, {'measure': 'Change from baseline in peak power output', 'timeFrame': 'Up to 20 minutes', 'description': 'Peak power output in Watts, determined on a cycle ergometer'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in blood oxygen saturation', 'timeFrame': 'Up to 20 minutes', 'description': 'Blood oxygen saturation as determined by pulse oximetry'}, {'measure': 'Change from baseline in quadriceps tissue oxygenation index', 'timeFrame': 'Up to 20 minutes', 'description': 'Tissue oxygenation index (oxygenated hemoglobin/total hemoglobin) as measured by near infra-red spectroscopy'}, {'measure': 'Change from baseline in rating of perceived exertion', 'timeFrame': 'Up to 20 minutes', 'description': 'Rating of perceived exertion on a scale of 1-10 (Modified Borg Scale), a higher score indicates a greater perceived exertion'}, {'measure': 'Change from baseline in heart rate', 'timeFrame': 'Up to 20 minutes', 'description': 'Heart rate (beats per minute)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypoxemia']}, 'referencesModule': {'references': [{'pmid': '33153145', 'type': 'DERIVED', 'citation': 'Shaw K, Butcher S, Ko J, Zello GA, Chilibeck PD. Wearing of Cloth or Disposable Surgical Face Masks has no Effect on Vigorous Exercise Performance in Healthy Individuals. Int J Environ Res Public Health. 2020 Nov 3;17(21):8110. doi: 10.3390/ijerph17218110.'}]}, 'descriptionModule': {'briefSummary': 'There is concern that wearing a face mask during COVID will affect oxygen uptake, especially during intense exercise. This study will assess the effect of wearing two different face masks (disposable and cloth) on blood and muscle oxygenation during cycling exercise.', 'detailedDescription': 'There is concern that wearing a face mask during exercise will reduce oxygen uptake or increase carbon dioxide re-breathing, which can result in low blood oxygen levels, reduced oxygen delivery to muscle and reduced exercise capacity. The purpose of the study is to determine the effect of wearing two different types of commonly-worn face masks (diposable and cloth) during exercise on blood and muscle oxygenation. Twelve participants who are experienced with cycling will take part in this randomized cross-over study that will assess blood oxygenation (i.e. pulse oximetry) and muscle oxygenation (with near infrared spectroscopy) during a progressive step exercise test to exhaustion. The conditions include no mask, a disposable mask, and a cloth mask. Outcome variables include exercise duration, rating of perceived exertion, blood oxygen saturation levels, and oxygenated, deoxygenated, and total hemoglobin at the quadriceps muscle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Experienced with cycling\n\nExclusion Criteria:\n\n* Contra-indications to exercise as identified by a screening questionnaire (the "Get Active Questionnaire")'}, 'identificationModule': {'nctId': 'NCT04557605', 'briefTitle': 'Effects of a Face Mask on Oxygenation During Exercise', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'The Effects of Wearing a Face Mask During COVID-19 on Blood and Muscle Oxygenation While Performing Exercise', 'orgStudyIdInfo': {'id': '2201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'No face mask', 'description': 'Progressive step-exercise cycling test to exhaustion wearing no face mask', 'interventionNames': ['Other: Progressive cycling exercise test to exhaustion']}, {'type': 'EXPERIMENTAL', 'label': 'Disposable face mask', 'description': 'Progressive step-exercise cycling test to exhaustion wearing a 3-ply disposable face mask', 'interventionNames': ['Other: Progressive cycling exercise test to exhaustion']}, {'type': 'EXPERIMENTAL', 'label': 'Cloth face mask', 'description': 'Progressive step-exercise cycling test to exhaustion wearing a cloth face mask', 'interventionNames': ['Other: Progressive cycling exercise test to exhaustion']}], 'interventions': [{'name': 'Progressive cycling exercise test to exhaustion', 'type': 'OTHER', 'description': 'Progressive step cycling exercise test to exhaustion', 'armGroupLabels': ['Cloth face mask', 'Disposable face mask', 'No face mask']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7N5B2', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'University of Saskatchewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Philip Chilibeck, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Saskatchewan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Phil Chilibeck', 'investigatorAffiliation': 'University of Saskatchewan'}}}}