Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2026-01-09 @ 7:44 PM
Study NCT ID:
NCT03352505
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2017-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Risk Markers in Spinal Cord Injured Subjects of the Wheelchair Dancer Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2017-11-16', 'studyFirstSubmitQcDate': '2017-11-20', 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison of cardiovascular risk factors between different study groups', 'timeFrame': 'October 2017- June 2018', 'description': 'measurement for arterial stiffness parameters, via pulse wave analysis. Comparison between healthy individuals and patients using wheelchairs (three different groups).'}, {'measure': 'Evaluation of echocardiography results between different study groups', 'timeFrame': 'October 2017- June 2018', 'description': 'Evaluation of echocardiography comparing healthy individuals and patients using wheelchairs (three different groups).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SCI - Spinal Cord Injury', 'Cardiovascular Risk Factor']}, 'descriptionModule': {'briefSummary': 'The present study will analyze if exercise is able to elicit the well-known anti-atherogenic effects in patients with SCI. This will be evaluated by measuring vascular parameters such as endothelial and inflammatory blood markers, echocardiography of the heart and peripheral vessels, as well as blood pressure and arterial stiffness, in subjects performing either wheelchair dancing, wheelchair marathon or no sports. Further, it will be investigated, whether there is an association between neuroplasticity and cardiovascular health, as measured by electroencephalography (EEG), transcranial magnetic stimulation (TMS) and blood levels of the brain-derived neurotrophic factor (BDNF).\n\nWe hypothesize that the cardiovascular, physical and psychological benefits of wheelchair dancing and/or wheelchair marathon parallel improved neuroplasticity in SCI-patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'healthy participants, wheelchair users', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nwheelchair users independent of the cause of the walking impairment, preferably with spinal cord injury.\n\nExclusion Criteria:\n\nmetallic implanters, additional neurologic pathologies, pregnancy'}, 'identificationModule': {'nctId': 'NCT03352505', 'briefTitle': 'Cardiovascular Risk Markers in Spinal Cord Injured Subjects of the Wheelchair Dancer Study', 'organization': {'class': 'OTHER', 'fullName': 'Paracelsus Medical University'}, 'officialTitle': 'Associations Between the Cardiovascular Risk Markers and Neuroplasticity in Sedentary or Physically Active Spinal Cord Injured Subjects of the Wheelchair Dancer Study', 'orgStudyIdInfo': {'id': 'UISM-12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control', 'description': 'healthy walking control participants'}, {'label': 'wheelchair dancer', 'description': 'wheelchair users, who are performing wheelchair dancing'}, {'label': 'wheelchair marathon participants', 'description': 'wheelchair users, who are participants in wheelchair/ handbike Marathon competitions'}, {'label': 'sedentary wheelchair patients', 'description': 'wheelchair users, who conduct exercise bouts less than 2 times per month'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University Salzburg', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paracelsus Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Josef Niebauer, M.D., Ph.D, MBA', 'investigatorFullName': 'Prof. Josef Niebauer M.D., Ph.D., MBA', 'investigatorAffiliation': 'Paracelsus Medical University'}}}}