Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT04688502
Status:
WITHDRAWN
Last Update Posted:
2025-04-24
First Post:
2020-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Wearing a Face Mask During CrossFit Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'It was not feasible for us to run this study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-06-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-19', 'studyFirstSubmitDate': '2020-12-24', 'studyFirstSubmitQcDate': '2020-12-24', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in box jumps', 'timeFrame': 'Up to 30 minutes', 'description': 'Number of box jump repetitions during high intensity exercise'}, {'measure': 'Change from baseline in pull-up, push-up, and squat repetitions', 'timeFrame': 'Up to 30 minutes', 'description': 'Number of repetitions performed for pull-ups, push-ups, and squats'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in rating of perceived exertion', 'timeFrame': 'Up to 30 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 30 minutes', 'description': 'Heart rate (beats per minute)'}, {'measure': 'Change from baseline in dyspnea', 'timeFrame': 'Up to 30 minutes', 'description': 'Dyspnea scale (0-10), a higher score indicates increased dyspnea'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyspnea']}, 'descriptionModule': {'briefSummary': 'Face masks are important for prevention of transmission and contracting viruses such as COVID-19. Gymnasiums have been identified as being susceptible to virus transmission; therefore, wearing face masks during exercise is important during pandemics. This study will evaluate performance and physiological stress during high-intensity exercise while wearing a face mask during Crossfit exercise training.', 'detailedDescription': 'Face masks are important for prevention of transmission and contracting viruses such as COVID-19. Gymnasiums have been identified as being susceptible to virus transmission; therefore, wearing face masks during exercise is important during pandemics. This study will evaluate performance and physiological stress during high-intensity exercise while wearing a face mask during Crossfit exercise training. Twenty-four men and women will be randomly assigned to perform exercise during Crossfit exercise while wearing or not wearing a surgical face mask in a cross-over study. Two types of exercise sessions will be assessed: A high intensity interval session and a continuous exercise session. There will therefore be four exercise sessions evaluated in our randomized cross-over design: 1) high intensity exercise while wearing a face mask; 2) high intensity exercise with no face mask; 3) continuous exercise while wearing a face mask; 4) continuous exercise with no face mask. Outcome variables to be assessed include exercise performance during the sessions (total repetitions for pull-ups, push-ups, and squats during continuous exercise and total repetitions for box jumps during high-intensity exercise). Heart rate, rating of perceived exertion, and dyspnea will also be assessed throughout the exercise sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Experienced with CrossFit exercise training\n\nExclusion Criteria:\n\n* Contra-indications to exercise as identified by a screening questionnaire (the "Get Active Questionnaire")'}, 'identificationModule': {'nctId': 'NCT04688502', 'briefTitle': 'Effects of Wearing a Face Mask During CrossFit Exercise', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'The Effects of Wearing a Face Mask During COVID-19 on Performance and Intensity Markers During CrossFit Exercise', 'orgStudyIdInfo': {'id': '2431'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high intensity interval training wearing a face mask', 'description': 'high intensity interval training wearing a face mask', 'interventionNames': ['Other: High intensity interval training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'high intensity interval training wearing no face mask', 'description': 'high intensity interval training wearing no face mask', 'interventionNames': ['Other: High intensity interval training']}, {'type': 'EXPERIMENTAL', 'label': 'continuous exercise training wearing a face mask', 'description': 'continuous exercise training wearing a face mask', 'interventionNames': ['Other: Continuous exercise training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'continuous exercise training wearing no face mask', 'description': 'continuous exercise training wearing no face mask', 'interventionNames': ['Other: Continuous exercise training']}], 'interventions': [{'name': 'High intensity interval training', 'type': 'OTHER', 'description': 'High intensity interval training: 6 sets x 8 bench press, 10 pull-ups, and maximal number of box jumps (each set lasting 60 sec, with 4 minutes rest between sets)', 'armGroupLabels': ['high intensity interval training wearing a face mask', 'high intensity interval training wearing no face mask']}, {'name': 'Continuous exercise training', 'type': 'OTHER', 'description': '5 pull-ups, 10 push-ups, and 15 body-weight squats, repeated for 30 minutes', 'armGroupLabels': ['continuous exercise training wearing a face mask', 'continuous exercise training wearing 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'}, {'name': 'Scotty Butcher, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Saskatchewan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Phil Chilibeck', 'investigatorAffiliation': 'University of Saskatchewan'}}}}