Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 10:01 AM
Study NCT ID:
NCT04226534
Status:
RECRUITING
Last Update Posted:
2020-05-28
First Post:
2019-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Psychophysiological Database of Maximal Effort Tests.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2040-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-26', 'studyFirstSubmitDate': '2019-12-18', 'studyFirstSubmitQcDate': '2020-01-08', 'lastUpdatePostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2040-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ergospirometry', 'timeFrame': 'Up to one hour', 'description': 'oxygen consumption and carbon di-oxide production (ml/min/kg)'}], 'secondaryOutcomes': [{'measure': 'blood samples', 'timeFrame': 'Up to one hour', 'description': 'Lactate concentration (mmol)'}, {'measure': 'Rating of perceived effort', 'timeFrame': 'Up to one hour', 'description': 'Rating of Perceived exertion on a scale from six to twenty'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sports Physical Therapy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is first to construct a database containing psychophysiological data from athletes performing a maximal effort test. Second, the investigators want to use the data to optimize the methodological approach during, and trainings advice after maximal effort tests.', 'detailedDescription': 'The lab (and research group) of Human Physiology and Sports Physiotherapy of the Vrije Universiteit Brussel performs exercise tests in both trained and untrained populations. The aim of the maximal effort test is to evaluate endurance capacity and provide recommendations to monitor training load. Until now, this is done by objective parameters such as heart rate, speed, time, power, etcetera. Researchers already presented a method to quantify training intensity distribution in elite endurance athletes based on the rating of perceived exertion. However, during pilot testing and everyday experience, these cut-off values are not always applicable to each individual athlete, nor are they the same for different sports. Therefore, the investigators want to investigate the possible relation between the exercise intensity, and objective and subjective parameters. Thereafter, the investigators want to provide recommendations to a new way of methodological approach during, and trainings advice after maximal effort tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Trained\n* No medication influencing heart rate or physical performance\n\nExclusion Criteria:\n\n* Disease\n* injury\n* medication influencing (maximal) heart rate or exercise performance\n\nDecision made after sports medical evaluation, comprising personal and family history, physical examination and resting electrocardiogram (ECG).'}, 'identificationModule': {'nctId': 'NCT04226534', 'briefTitle': 'A Psychophysiological Database of Maximal Effort Tests.', 'organization': {'class': 'OTHER', 'fullName': 'Vrije Universiteit Brussel'}, 'officialTitle': 'Constructing a Psychophysiological Database Towards the Optimization of the Methodological Approach During, and Training Advice After Maximal Effort Tests.', 'orgStudyIdInfo': {'id': 'VUB-BLITS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Maximal effort test', 'description': 'Physiological database', 'interventionNames': ['Other: Maximal effort test']}], 'interventions': [{'name': 'Maximal effort test', 'type': 'OTHER', 'description': 'Performing a maximal effort test on the treadmill', 'armGroupLabels': ['Maximal effort test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1050', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Luk Buyse, Msc. dr.', 'role': 'CONTACT', 'email': 'luk.buyse@vub.be', 'phone': '+32 2 629 22 22'}], 'facility': 'Vrije Universiteit Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Luk Buyse, Msc. dr.', 'role': 'CONTACT', 'email': 'luk.buyse@vub.be', 'phone': '+32 2 629 22 22'}, {'name': 'Jo Ghillebert, Msc.', 'role': 'CONTACT', 'email': 'jo.ghillebert@vub.be', 'phone': '+32 2 629 22 22'}], 'overallOfficials': [{'name': 'Luk Buyse, Msc. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vrije Universiteit Brussel, Human Physiology and Sports Physiotherapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vrije Universiteit Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Jo Ghillebert', 'investigatorAffiliation': 'Vrije Universiteit Brussel'}}}}