Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT04891120
Status:
COMPLETED
Last Update Posted:
2021-07-27
First Post:
2021-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treadmill Stress Test With and Without Mask
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002006', 'term': 'Brucellosis'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The statistician will be masked.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-26', 'studyFirstSubmitDate': '2021-05-05', 'studyFirstSubmitQcDate': '2021-05-13', 'lastUpdatePostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Exercise Duration With vs Without a Mask', 'timeFrame': 'Through study completion, an average of 1 week'}, {'measure': 'Change in Heart Rate During Exercise With vs Without a Mask', 'timeFrame': 'Through study completion, an average of 1 week'}, {'measure': 'Change in Blood Pressure During Exercise With vs Without a Mask', 'timeFrame': 'Through study completion, an average of 1 week'}, {'measure': 'Change in Oxygen Saturation During Exercise With vs Without a Mask', 'timeFrame': 'Through study completion, an average of 1 week'}, {'measure': 'Change in Duration of Exercise Before Reaching 85% of Predicted Maximal Heart Rate With vs Without a Mask', 'timeFrame': 'Through study completion, an average of 1 week'}, {'measure': 'Change in Calculated Maximal Oxygen Consumption During Exercise With vs Without a Mask', 'timeFrame': 'Through study completion, an average of 1 week'}], 'primaryOutcomes': [{'measure': 'Change in Metabolic Equivalents With vs Without a Mask', 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'The maximal metabolic equivalents achieved will be calculated for each treadmill test performed.'}], 'secondaryOutcomes': [{'measure': "Change in Borg's Category-Ratio Scale for Rating of Perceived Exertion With vs Without a Mask", 'timeFrame': 'Through study completion, an average of 1 week', 'description': 'The Borg Scale is a self-reporting instrument assessing intensity of perceived exertion on a 0 to 10 scale, 0 being rest and 10 maximal effort.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Treadmill', 'Bruce', 'COVID-19', 'Mask', 'Healthy', 'Adults', 'METS', 'Metabolic equivalent', 'Borg', 'Exercise', 'Stress test'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess if wearing a surgical mask affects the results of a standard treadmill test.', 'detailedDescription': 'The persons interested to participate will be informed of the implication and potential risks associated with the study. The participants that accept and meet the eligibility criteria will give written consent and be randomized into two groups. One group will first perform a treadmill test with a surgical mask and then repeat the test without a mask. The second group will do the first treadmill test without a mask and the second one with a surgical mask.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18-65 years old)\n* Healthy\n* Vaccinated against COVID-19\n\nExclusion Criteria:\n\n* Any cardiac or respiratory condition\n* Walking difficulty\n* Waiting for a stress test for a medical reason\n* Abnormal resting ECG\n* Inability to wear a mask\n* Inability to understand or follow the instructions\n* Medical contraindication to performing a treadmill stress test'}, 'identificationModule': {'nctId': 'NCT04891120', 'acronym': 'TREADMASK', 'briefTitle': 'Treadmill Stress Test With and Without Mask', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Treadmill Stress Test With and Without Mask: Comparison of Exercise Capacity and Perception', 'orgStudyIdInfo': {'id': '2021-4210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'With, then without a mask', 'description': 'Participants will first perform a treadmill test with a mask and 48 hours or more later will perform another similar treadmill test without a mask.', 'interventionNames': ['Diagnostic Test: Treadmill test (Bruce protocol)']}, {'type': 'EXPERIMENTAL', 'label': 'Without, then with a mask', 'description': 'Participants will first perform a treadmill test without a mask and 48 hours or more later will perform another similar treadmill test with a mask.', 'interventionNames': ['Diagnostic Test: Treadmill test (Bruce protocol)']}], 'interventions': [{'name': 'Treadmill test (Bruce protocol)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Treadmill test performed with and without a mask.', 'armGroupLabels': ['With, then without a mask', 'Without, then with a mask']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Warner Mampuya, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'The data will be available at the time of the publication and for the 2 following years.', 'ipdSharing': 'YES', 'description': 'All IPD that underlies results in a publication will be available in the supplementary appendix of the publication or on request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}