Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT03439202
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2018-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low Intensity Exercise in Different Normobaric/Hypobaric Normoxic/Hypoxic Conditions.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No drug and no arm are used for this study. This is a clinical study, because subjects are exposed to hypoxic conditions.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Crossover randomized study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-14', 'studyFirstSubmitDate': '2018-01-26', 'studyFirstSubmitQcDate': '2018-02-13', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baro-reflex sensitivity', 'timeFrame': '6 minutes per record.', 'description': 'To test the strength of relationship between RR interval and systolic blood pressure in human. Measurement before and after low intensity exercise in each condition.'}], 'secondaryOutcomes': [{'measure': 'Concentration performance', 'timeFrame': '4 minutes per test', 'description': 'Subjects will conduct a concentration test in each condition.'}, {'measure': 'EEG microstates', 'timeFrame': '6 minutes per record', 'description': 'Microstates analysis to investigate how electrical cerebral activity is affected at rest in hypoxia and influenced by low intensity cycling exercise.'}, {'measure': 'Heart rate variability (HRV)', 'timeFrame': '6 minutes per record', 'description': 'To investigate about stress (sympathetic and parasympathetic activation) in each condition tested.'}, {'measure': 'Cerebral blood flow', 'timeFrame': '6 minutes per record.', 'description': 'Regulation of cerebral blood flow in hypoxia at rest and during low-intensity exercise. Measurement before, during and after low intensity exercise in each condition. 6 minutes recording per measurement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypoxia', 'Baro-reflex sensitivity', 'Low-intensity exercise', 'Hear rate variability', 'EEG', 'Concentration performance'], 'conditions': ['Baro-reflex Sensitivity', 'Heart Rate Variability', 'EEG, Microstates', 'Cerebral Blood Flow Regulation', 'Cerebral Oxygenation', 'Oxygen Saturation', 'Concentration Performance']}, 'descriptionModule': {'briefSummary': 'The main goal of this project is to investigate how low intensity cycling exercise (1.5W/kg, for 6 minutes) influences cerebral functions, such as: Cerebral blood flow, oxygenation, and other physiological variables in different normobaric and hypobaric hypoxic conditions.', 'detailedDescription': 'Subjects will bike at 1W/kg for 6 minutes at different simulated altitude level in the hypobaric chamber at the FAI in Dübendorf. Concentration performance also will be measured to better understand how hypobaric and hypoxia conditions may affect physiological responses, cerebral and cognitive functions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Study Indication\n* Male and Female subjects from 18 years to 40 years of age\n* Healthy volunteer\n* Signed Informed Consent after being informed\n\nExclusion Criteria:\n\n* Contraindications to the study intervention.\n* Define drugs, treatments or interventions not allowed during the study or for specific periods of time prior to the intervention,\n* Women who are pregnant or breast feeding,\n* Intention to become pregnant during the course of the study,\n* Known or suspected non-compliance, drug or alcohol abuse,\n* Previous problem with hypoxia or altitude exposure,\n* Known pathologies/diseases\n* Relevant medical disorders\n* Anemia or poor health\n* History of flight sickness'}, 'identificationModule': {'nctId': 'NCT03439202', 'acronym': 'Hypoxia', 'briefTitle': 'Low Intensity Exercise in Different Normobaric/Hypobaric Normoxic/Hypoxic Conditions.', 'organization': {'class': 'OTHER', 'fullName': 'Fliegerärztliches Institut'}, 'officialTitle': 'The Effects of Low Intensity Exercise in Hypobaric vs. Normobaric Normoxic and Hypoxic Conditions on Baroreflex Sensitivity, Physiological Responses and Cerebral Functions in Pilots.', 'orgStudyIdInfo': {'id': '2018-00006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'No arm used', 'description': 'No drug use for this study. No arm used in this study. Subjects are exposed to hypoxic conditions (clinical study).', 'interventionNames': ['Other: Hypoxia']}], 'interventions': [{'name': 'Hypoxia', 'type': 'OTHER', 'otherNames': ['Low-intensity cycling exercise'], 'description': 'Subject will conduct low-intensity exercise on a bike in different hypoxic conditions.', 'armGroupLabels': ['No arm used']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8600', 'city': 'Dübendorf', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Aeromedical Center / Fliegerärztliches Institut', 'geoPoint': {'lat': 47.39724, 'lon': 8.61872}}], 'overallOfficials': [{'name': 'Denis Bron, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aeromedical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fliegerärztliches Institut', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Lausanne', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}