Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-27 @ 2:35 AM
Study NCT ID:
NCT04832893
Status:
COMPLETED
Last Update Posted:
2021-05-13
First Post:
2021-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Masks on Metabolic Parameters and Inspiratory Muscle Strength During Aerobic Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-12', 'studyFirstSubmitDate': '2021-04-02', 'studyFirstSubmitQcDate': '2021-04-02', 'lastUpdatePostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inspiratory muscle strength', 'timeFrame': 'change from baseline inspiratory muscle strength after the 30 minutes test', 'description': 'Inspiratory muscle strength will be measured in mmHg with a Power-breathe device'}], 'secondaryOutcomes': [{'measure': 'lactate concentrations', 'timeFrame': 'change from baseline after 10 minutes, 20 minutes and 30 minutes during the test', 'description': 'lactate concentration will be measured in mmol/L with a Lactate Pro 2 device'}, {'measure': 'oxygen saturation', 'timeFrame': 'change from baseline after 10 minutes, 20 minutes and 30 minutes during the test', 'description': 'oxygen saturation will be measured in %'}, {'measure': 'heart rate', 'timeFrame': 'change from baseline after 10 minutes, 20 minutes and 30 minutes during the test', 'description': 'heart rate will be measured in beats per minute with a polar H10 device'}, {'measure': 'rate of perceived effort', 'timeFrame': 'change from baseline after 10 minutes, 20 minutes and 30 minutes during the test', 'description': 'rate of perceived effort will be obtained through the Borg´ scale'}, {'measure': 'sensation of dyspnea', 'timeFrame': 'change from baseline after 10 minutes, 20 minutes and 30 minutes during the test', 'description': 'sensation of dyspnea will be obtained through a visual analog scale from 0 to 10 points'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Masks']}, 'descriptionModule': {'briefSummary': 'The purpose of this study will be to assess the effects of the use of masks on inspiratory muscle strength, metabolic parameters, heart rate, subjective perception of effort and the sensation of dyspnea before, during and after an aerobic test of 30 minutes long and a fixed load at lactate threshold. A randomized study of repeated measures will be carried out. A total sample of 35 active participants will be recruited. All participants will carried out a lactate threshold test and then 3 visits to the laboratory (separated at least 48 hours from each other) in order to perform 3 test of 30 minutes long without mask, with a surgical mask or with a FFP2 respirator (in a randomized order) at an intensity around lactate threshold intensity. Maximal inspiratory pressure, oxygen saturation, heart rate, blood lactate concentration, subjective perception of effort and dyspnea will be assessed before, during and after the 3 fixed intensity tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* carrying out at least 2 days of physical activity per week\n\nExclusion Criteria:\n\n* cardiac disease\n* pulmonary disease\n* chronic inflammatory disease\n* sedentary behaviour'}, 'identificationModule': {'nctId': 'NCT04832893', 'briefTitle': 'Use of Masks on Metabolic Parameters and Inspiratory Muscle Strength During Aerobic Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Francisco de Vitoria'}, 'officialTitle': 'Effects of Different Masks on Metabolic Parameters, Inspiratory Muscle Strength and Perceived Effort During Low Intensity Aerobic Exercise', 'orgStudyIdInfo': {'id': 'UFV_20/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Use of FFP2 respirator', 'description': 'Using of FFP2 respirator during the 30 minutes test', 'interventionNames': ['Diagnostic Test: steady intensity aerobic test of 30 minutes long']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Use of surgical mask', 'description': 'Using of surgical mask during the 30 minutes test', 'interventionNames': ['Diagnostic Test: steady intensity aerobic test of 30 minutes long']}, {'type': 'SHAM_COMPARATOR', 'label': 'no mask', 'description': 'The 30 minutes test will be carried out without mask', 'interventionNames': ['Diagnostic Test: steady intensity aerobic test of 30 minutes long']}], 'interventions': [{'name': 'steady intensity aerobic test of 30 minutes long', 'type': 'DIAGNOSTIC_TEST', 'description': 'the use of different type of masks during an aerobic exercise', 'armGroupLabels': ['Use of FFP2 respirator', 'Use of surgical mask', 'no mask']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28223', 'city': 'Pozuelo de Alarcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Universidad Francisco de Vitoria', 'geoPoint': {'lat': 40.43293, 'lon': -3.81338}}], 'overallOfficials': [{'name': 'Davinia Vicente Campos, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Francisco de Vitoria'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Francisco de Vitoria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}