Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-28 @ 12:14 PM
Study NCT ID:
NCT06308432
Status:
COMPLETED
Last Update Posted:
2024-06-24
First Post:
2024-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sweat Rate Measurement With a Sensor (Wearable) in Different Climatic Conditions With Road Cyclists.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D003080', 'term': 'Cold Temperature'}, {'id': 'C505729', 'term': 'SLH1 protein, Arabidopsis'}, {'id': 'D003972', 'term': 'Diathermy'}], 'ancestors': [{'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D013696', 'term': 'Temperature'}, {'id': 'D013816', 'term': 'Thermodynamics'}, {'id': 'D014887', 'term': 'Weather'}, {'id': 'D001272', 'term': 'Atmosphere'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-21', 'studyFirstSubmitDate': '2024-02-15', 'studyFirstSubmitQcDate': '2024-03-08', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sweat', 'timeFrame': 'Change of baseline rate of sweet rate in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)', 'description': 'The amount of sweat will be measured by a sensor placed on the back.'}], 'secondaryOutcomes': [{'measure': 'Microcapillary Blood', 'timeFrame': 'Change of baseline rate of sweet rate in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)', 'description': 'By means of a lancet puncture in the thumb of the finger, 70 ml of capillary blood will be extracted.This test provides biochemical variables (ABL90FLEX) with 70 ml of capillary blood.'}, {'measure': 'Heart Rate', 'timeFrame': 'Changes of heart rate in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)', 'description': 'The heart rate will be evaluated by means of a heart rate strap.'}, {'measure': 'Fatigue', 'timeFrame': 'Change of fatigue in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)', 'description': 'Rate of perceived exertion using Borg scale. En esta escala 0 representa nada fatigado y el 10 esfuerzo máximo.'}, {'measure': 'Temperature on the forehead', 'timeFrame': 'Changes in Temperature on the forehead in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)', 'description': 'The temperature will be measured by an infrared thermometer.'}, {'measure': 'Temperature in the ear', 'timeFrame': 'Changes in Temperature in the ear in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)', 'description': 'The temperature will be measured by ear thermometer.'}, {'measure': 'Sleep efficiency', 'timeFrame': 'Changes in the sleep efficiency in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)', 'description': 'Measured by accelerometry, with Actigraph wGT3X-BT'}, {'measure': 'Karolinska drowsiness scale', 'timeFrame': 'It will be measured the day after in six occasions (the first day, day 7, day, 14, day 21, day 28, day 35)', 'description': 'Measured by Karolinska test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cyclist', 'Performance', 'Temperature', 'Humidity'], 'conditions': ['Sweat']}, 'descriptionModule': {'briefSummary': 'Controlled, double-blind, crossover clinical trial with six parallel arms depending on the combination of temperature and humidity (22º and 40% humidity, 35º 40% humidity and 35º and 65% humidity), with two differents intensity, to investigate and validate the physiological use of a sensor in recreational road cyclists.', 'detailedDescription': 'Subjects who meet the inclusion criteria will be recruited to participate in the clinical trial and perform the exercise sessions.\n\nThe cyclists in the study will have to make 7 visits to the laboratory. At the first visit, their aerobic performance will be evaluated by an incremental test to exhaustion with gas analysis. And in the next 6 visits they will have to perform a sustained intensity exercise with different environmental conditions according to the combination of temperature, humidity and intensity.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male cyclists with more than two years of cycling experience.\n* Perform tests without fatigue.\n* Road bike training at least twice a week.\n\nExclusion Criteria:\n\n* Participants with chronic illness.\n* Have a long-term injury that prevents you from training in the previous month.\n* Inability to understand informed consent.\n* Use of diuretics in the month prior to or during the measurement period.'}, 'identificationModule': {'nctId': 'NCT06308432', 'acronym': 'CYSU', 'briefTitle': 'Sweat Rate Measurement With a Sensor (Wearable) in Different Climatic Conditions With Road Cyclists.', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Católica San Antonio de Murcia'}, 'officialTitle': 'Sweat Rate Measurement With a Sensor (Wearable) in Different Climatic Conditions With Road Cyclists.', 'orgStudyIdInfo': {'id': 'UCAMCFE-00036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '22 degrees, 40% humidity and 50% intensity', 'description': 'The room in which the 30-minute test will be performed will be at 22 degrees Celsius and 40% humidity.\n\nThe subject should perform the test at 50% of the power at which he reached his VO2max.', 'interventionNames': ['Other: Low intensity', 'Other: Low temperature', 'Other: Low Humidity']}, {'type': 'EXPERIMENTAL', 'label': '35 degrees, 40% humidity and 50% intensity', 'description': 'The room in which the 30-minute test will be performed will be at 35 degrees Celsius and 40% humidity.\n\nThe subject should perform the test at 50% of the power at which he reached his VO2max.', 'interventionNames': ['Other: Low intensity', 'Other: Low Humidity', 'Other: High temperature']}, {'type': 'EXPERIMENTAL', 'label': '35 degrees, 65% humidity and 50% intensity', 'description': 'The room in which the 30-minute test will be performed will be at 35 degrees Celsius and 65% humidity.\n\nThe subject should perform the test at 50% of the power at which he reached his VO2max.', 'interventionNames': ['Other: Low intensity', 'Other: High temperature', 'Other: High humidity']}, {'type': 'EXPERIMENTAL', 'label': '22 degrees, 40% humidity and 60% intensity', 'description': 'The room in which the 30-minute test will be performed will be at 22 degrees Celsius and 40% humidity.\n\nThe subject should perform the test at 60% of the power at which he reached his VO2max.', 'interventionNames': ['Other: Low temperature', 'Other: Low Humidity', 'Other: High intensity']}, {'type': 'EXPERIMENTAL', 'label': '35 degrees, 40% humidity and 60% intensity', 'description': 'The room in which the 30-minute test will be performed will be at 35 degrees Celsius and 40% humidity.\n\nThe subject should perform the test at 60% of the power at which he reached his VO2max.', 'interventionNames': ['Other: Low Humidity', 'Other: High intensity', 'Other: High temperature']}, {'type': 'EXPERIMENTAL', 'label': '35 degrees, 65% humidity and 60% intensity', 'description': 'The room in which the 30-minute test will be performed will be at 35 degrees Celsius and 65% humidity.\n\nThe subject should perform the test at 60% of the power at which he reached his VO2max.', 'interventionNames': ['Other: High intensity', 'Other: High temperature', 'Other: High humidity']}], 'interventions': [{'name': 'Low intensity', 'type': 'OTHER', 'description': 'The subject will perform the 30-minute test at an intensity of 50% of the power at which he/she has reached his/her VO2max.', 'armGroupLabels': ['22 degrees, 40% humidity and 50% intensity', '35 degrees, 40% humidity and 50% intensity', '35 degrees, 65% humidity and 50% intensity']}, {'name': 'Low temperature', 'type': 'OTHER', 'description': 'The performance test will be carried out in a room conditioned to a temperature of 22º.', 'armGroupLabels': ['22 degrees, 40% humidity and 50% intensity', '22 degrees, 40% humidity and 60% intensity']}, {'name': 'Low Humidity', 'type': 'OTHER', 'description': 'The performance test will be carried out in a room conditioned to 40% humidity.', 'armGroupLabels': ['22 degrees, 40% humidity and 50% intensity', '22 degrees, 40% humidity and 60% intensity', '35 degrees, 40% humidity and 50% intensity', '35 degrees, 40% humidity and 60% intensity']}, {'name': 'High intensity', 'type': 'OTHER', 'description': 'The subject will perform the 30-minute test at an intensity of 60% of the power at which he/she has reached his/her VO2max.', 'armGroupLabels': ['22 degrees, 40% humidity and 60% intensity', '35 degrees, 40% humidity and 60% intensity', '35 degrees, 65% humidity and 60% intensity']}, {'name': 'High temperature', 'type': 'OTHER', 'description': 'The performance test will be carried out in a room conditioned to a temperature of 35º.', 'armGroupLabels': ['35 degrees, 40% humidity and 50% intensity', '35 degrees, 40% humidity and 60% intensity', '35 degrees, 65% humidity and 50% intensity', '35 degrees, 65% humidity and 60% intensity']}, {'name': 'High humidity', 'type': 'OTHER', 'description': 'The performance test will be carried out in a room conditioned to 65% humidity.', 'armGroupLabels': ['35 degrees, 65% humidity and 50% intensity', '35 degrees, 65% humidity and 60% intensity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30107', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Catholic University of Murcia', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Católica San Antonio de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Francisco Javier López Román', 'investigatorAffiliation': 'Universidad Católica San Antonio de Murcia'}}}}