Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-02-25 @ 8:17 PM
Study NCT ID:
NCT02880150
Status:
COMPLETED
Last Update Posted:
2016-08-26
First Post:
2013-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiological Characteristics of High Altitude Climbers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-22', 'studyFirstSubmitDate': '2013-10-21', 'studyFirstSubmitQcDate': '2016-08-22', 'lastUpdatePostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance reduction in hypoxia versus normoxia', 'timeFrame': 'Day one on the evaluation day', 'description': 'Difference in maximal cycling power output between the normoxic and the hypoxic exercise test'}], 'secondaryOutcomes': [{'measure': 'Near infrared signals during exercise', 'timeFrame': 'Day one on the evaluation day', 'description': 'Differences in cerebral and muscle TOI during exercise between the normoxia and the hypoxic exercise'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['elite climbers', 'near infrared spectroscopy'], 'conditions': ['Hypoxia', 'Exercise', 'Sport Performance']}, 'referencesModule': {'references': [{'pmid': '22319046', 'type': 'BACKGROUND', 'citation': 'Verges S, Rupp T, Jubeau M, Wuyam B, Esteve F, Levy P, Perrey S, Millet GY. Cerebral perturbations during exercise in hypoxia. Am J Physiol Regul Integr Comp Physiol. 2012 Apr 15;302(8):R903-16. doi: 10.1152/ajpregu.00555.2011. Epub 2012 Feb 8.'}]}, 'descriptionModule': {'briefSummary': 'Climbing at high altitude and tolerating hypoxic environment require specific physiological adaptations. Large intersubjects differences exist regarding the ability to adapt to high altitude and hypoxia. The present study aims to characterise the physiological responses to hypoxia in a group of elite climbers by comparison to sea level athletes. We hypothesised that elite climbers would show better physiological responses to hypoxia and more preserved performances compared to sea level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 40\n* Member of the national high altitude climbing group\n\nExclusion Criteria:\n\n* Any diseases incompatible with hypoxic exposure, exercise testing\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02880150', 'acronym': 'ALTIPERF', 'briefTitle': 'Physiological Characteristics of High Altitude Climbers', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Physiological Characteristics of High Altitude Climbers', 'orgStudyIdInfo': {'id': '2013-A00629-36'}, 'secondaryIdInfos': [{'id': 'ALTIPERF', 'type': 'OTHER', 'domain': 'Grenoble University Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Elite climbers', 'description': 'Elite climbers selected in a national group for their previous performances at high altitude', 'interventionNames': ['Other: Stress test']}, {'type': 'OTHER', 'label': 'Sea level sportsmen', 'description': 'Control group with similar anthropometric, age, gender and maximal normoxic oxygen consumption that the elite climber group', 'interventionNames': ['Other: Stress test']}], 'interventions': [{'name': 'Stress test', 'type': 'OTHER', 'armGroupLabels': ['Elite climbers', 'Sea level sportsmen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38042', 'city': 'Grenoble', 'country': 'France', 'facility': 'Grenoble University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}