Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-01-07 @ 11:26 AM
Study NCT ID:
NCT03229434
Status:
COMPLETED
Last Update Posted:
2019-01-22
First Post:
2017-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mountain Hiking & Environmental Influences
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016138', 'term': 'Walking'}], 'ancestors': [{'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'pseudonymes'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-17', 'studyFirstSubmitDate': '2017-07-19', 'studyFirstSubmitQcDate': '2017-07-21', 'lastUpdatePostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline Cortisol (Saliva Sampling) at 6 hours', 'timeFrame': '6 hours', 'description': 'Physiological response'}, {'measure': 'Change from baseline subscales of mood survey scale at 6 hours', 'timeFrame': '6 hours', 'description': 'Psychological response'}], 'secondaryOutcomes': [{'measure': 'Change from baseline blood pressure at 6 hours', 'timeFrame': '6 hours'}, {'measure': 'Change from baseline lung function at 6 hours', 'timeFrame': '6 hours'}, {'measure': 'Change from baseline respiratory gas analysis at 6 hours', 'timeFrame': '6 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['affective responses', 'stress-related parameters', 'green exercise'], 'conditions': ['Healthy Participants']}, 'referencesModule': {'references': [{'pmid': '28520774', 'type': 'BACKGROUND', 'citation': 'Niedermeier M, Einwanger J, Hartl A, Kopp M. Affective responses in mountain hiking-A randomized crossover trial focusing on differences between indoor and outdoor activity. PLoS One. 2017 May 16;12(5):e0177719. doi: 10.1371/journal.pone.0177719. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'In a randomized crossover design, approximately 50 healthy participants will be randomly exposed to outdoor mountain hiking (approximately 6 hours each) in two different areas: an anthropogenically influenced area and in a widely pristine area.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* voluntary participation\n\nExclusion Criteria:\n\n* pregnancy\n* breastfeeding\n* chronic or acute diseases (already existing or diagnosed during the study)\n* unable to be physically active assessed by the Physical Activity Readiness Questionnaire'}, 'identificationModule': {'nctId': 'NCT03229434', 'briefTitle': 'Mountain Hiking & Environmental Influences', 'organization': {'class': 'OTHER', 'fullName': 'Universitaet Innsbruck'}, 'officialTitle': 'Effects of Mountain Hiking on Physiological and Psychological Health Parameters With Special Focus on the Influence of the Environment', 'orgStudyIdInfo': {'id': 'ARMH_2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Widely pristine area', 'description': 'Outdoor mountain hiking (approximately 6 hours, 8km, 800 altitude meters, estimated speed: 4km/h \\[uphill\\], 5.2km/h \\[downhill\\]) in a widely pristine area with moderate intensity (Rating of perceived exertion: \\~ 11-15).', 'interventionNames': ['Behavioral: Mountain hiking']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Anthropogenically influenced area', 'description': 'Outdoor mountain hiking (approximately 6 hours, 8km, 800 altitude meters, estimated speed: 4km/h \\[uphill\\], 5.2km/h \\[downhill\\]) in an anthropogenically influenced area with moderate intensity (Rating of perceived exertion: \\~ 11-15).\n\nAll characteristics of the hiking (duration, time, difference in altitude, ...) are planned to be comparable to the experimental condition except the area.', 'interventionNames': ['Behavioral: Mountain hiking']}], 'interventions': [{'name': 'Mountain hiking', 'type': 'BEHAVIORAL', 'otherNames': ['Walking'], 'description': 'Compare arm description', 'armGroupLabels': ['Anthropogenically influenced area', 'Widely pristine area']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Department of Sport Science, Medical Section, University of Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaet Innsbruck', 'class': 'OTHER'}, 'collaborators': [{'name': 'Paracelsus Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Martin Burtscher', 'investigatorAffiliation': 'Universitaet Innsbruck'}}}}