Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-02-22 @ 6:45 PM
Study NCT ID:
NCT04874766
Status:
COMPLETED
Last Update Posted:
2021-10-25
First Post:
2021-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Wearing a Face Mask During Exercise in Youth Hockey Players During COVID-19
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The participant will be blinded by wearing a sham mask during the "no mask" condition (i.e. they will wear a surgical mask with the covering for the mouth and nose cut out). The individual who will statistically analyze the data will be blinded to conditions'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-19', 'studyFirstSubmitDate': '2021-04-23', 'studyFirstSubmitQcDate': '2021-05-02', 'lastUpdatePostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in average power output', 'timeFrame': 'Up to 40 seconds', 'description': 'Average power output in Watts during two 20 second Wingate tests'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in peak power output', 'timeFrame': 'Up to 40 seconds', 'description': 'Peak power output in Watts during two 20 second Wingate tests'}, {'measure': 'Change from baseline in on-ice sprint testing distance', 'timeFrame': 'Up to 12 minutes', 'description': 'Distance in meters covered during a repeated 20-meter sprint test that progressively increases in speed'}, {'measure': 'Change from baseline in blood oxygen saturation', 'timeFrame': 'Up to 40 minutes', 'description': 'Blood oxygen saturation (%) determined by pulse oximetry'}, {'measure': 'Change from baseline in quadriceps tissue oxygenation index', 'timeFrame': 'Up to 40 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 40 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 40 minutes', 'description': 'Heart rate (beats per minute)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypoxemia']}, 'referencesModule': {'references': [{'pmid': '34682512', 'type': 'DERIVED', 'citation': 'Shaw KA, Butcher S, Ko JB, Absher A, Gordon J, Tkachuk C, Zello GA, Chilibeck PD. Wearing a Surgical Face Mask Has Minimal Effect on Performance and Physiological Measures during High-Intensity Exercise in Youth Ice-Hockey Players: A Randomized Cross-Over Trial. Int J Environ Res Public Health. 2021 Oct 14;18(20):10766. doi: 10.3390/ijerph182010766.'}]}, 'descriptionModule': {'briefSummary': 'There is concern that wearing a face mask during COVID will affect oxygen uptake, especially during intense exercise. COVID transmission is especially prevalent in sports such as hockey, where there is close contact between players and arena ventilation is poor. This study will assess the effect of wearing a surgical face mask on simulated hockey performance and blood and muscle oxygenation during cycling exercise.', 'detailedDescription': 'The sport of ice hockey involves close contact between players in poorly ventilated arenas. This increases susceptibility for transmission of viruses, such as COVID-19. Face masks can reduce the risk of virus transmission; however, 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 a surgical face mask during exercise that simulates ice hockey play on exercise performance and blood and muscle oxygenation in boys and girls. Twelve boys and twelve girls (age 9-14y) who are experienced playing hockey, will take part in this randomized cross-over study that will assess exercise performance, blood oxygenation (i.e. pulse oximetry) and muscle oxygenation (with near infrared spectroscopy) during an exercise test on a cycle ergometer with workloads and work to rest intervals that simulates hockey performance. Participants will also be tested for repeated-sprint performance on ice while wearing full hockey equipment. The conditions include no mask (a "sham" mask) and a surgical mask. Outcome variables include power output during the cycle ergometer testing, skating distance during the on-ice test, rating of perceived exertion, blood oxygen saturation levels, and oxygenated, deoxygenated, and total hemoglobin at the quadriceps muscle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Experience playing ice-hockey\n\nExclusion Criteria:\n\n* Contra-indications to exercise as identified by a screening questionnaire (the "Get Active Questionnaire")'}, 'identificationModule': {'nctId': 'NCT04874766', 'briefTitle': 'The Effects of Wearing a Face Mask During Exercise in Youth Hockey Players During COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': "The Effects of Wearing a Face Mask on Exercise Tolerance in Children's Hockey During the COVID-19 Pandemic", 'orgStudyIdInfo': {'id': '2701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgical face mask', 'description': 'Simulated hockey period with 2x20s Wingate tests; progressive-intensity on-ice sprint test while wearing a surgical mask', 'interventionNames': ['Other: Wingate exercise test and on-ice testing while wearing a face mask']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham face mask', 'description': 'Simulated hockey period with 2x20s Wingate tests; progressive-intensity on-ice sprint test while wearing a sham mask', 'interventionNames': ['Other: Wingate exercise test and on-ice testing while wearing a sham face mask']}], 'interventions': [{'name': 'Wingate exercise test and on-ice testing while wearing a face mask', 'type': 'OTHER', 'description': 'Power output during 2 x 20s Wingate cycle tests and total distance during an on-ice skating test while wearing a face mask', 'armGroupLabels': ['Surgical face mask']}, {'name': 'Wingate exercise test and on-ice testing while wearing a sham face mask', 'type': 'OTHER', 'description': 'Power output during 2 x 20s Wingate cycle tests and total distance during an on-ice skating test while wearing a face mask', 'armGroupLabels': ['Sham 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'}, 'collaborators': [{'name': 'Saskatchewan Health Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Phil Chilibeck', 'investigatorAffiliation': 'University of Saskatchewan'}}}}