Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-04-04 @ 11:45 AM
Study NCT ID:
NCT00912561
Status:
TERMINATED
Last Update Posted:
2012-02-22
First Post:
2009-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Intense Aerobic Exercise on the Cerebrovascular Reserve Capacity in Patients With Hemodynamically Relevant Intra- and Extracranial Stenoses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003251', 'term': 'Constriction, Pathologic'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'whyStopped': 'slow recruiting', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-02-20', 'studyFirstSubmitDate': '2009-06-02', 'studyFirstSubmitQcDate': '2009-06-02', 'lastUpdatePostDateStruct': {'date': '2012-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of cerebrovascular reserve capacity', 'timeFrame': 'immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up'}], 'secondaryOutcomes': [{'measure': 'Endothelial Progenitor Cells, cyto- and chemokines', 'timeFrame': 'after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up'}, {'measure': 'Neuropsychological Testing/ Quality of life', 'timeFrame': 'immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic brain ischaemia', 'stroke prevention', 'exercise', 'physical training', 'Chronic, extra- or intracranial stenoses of brain supplying arteries'], 'conditions': ['Stenosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to study the improvement of cerebral hemodynamics in high risk stroke patients with impaired Cerebrovascular Reserve (CVR) due to high grade stenosis of the internal carotid (ICA) or middle cerebral artery (MCA) by Intense Aerobic Exercise (IAEx).', 'detailedDescription': 'The primary objective: Intense aerobic exercise (24/8 weeks) improves CVR \\> 20% measured by Transcranial Doppler (TCD) in patients with hemodynamic relevant intra- or extracranial stenoses by enhanced cerebral arterio- and angiogenesis.\n\nSecondary objectives:\n\nIntense aerobic exercise (24/8 weeks) leads to:\n\n* an increase of Endothelial progenitor cell counts (EPCs)\n* qualitative and quantitative changes of endothelial markers and cytokines representing the inflammatory activity of atherosclerosis and neovascularisation\n* an improvement in cognitive performance and quality of life (QoL)\n* changes of the mean vessel size and of cerebral perfusion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* high-grade stenosis of the intra- or extracranial ICA or the MCA with ipsilateral impairment of the CVR capacity measured by TCD\n\nExclusion Criteria:\n\n* continuous physical activity ≥ 60 min/week within the last 3 months\n* cerebral bleeding or ischaemic stroke \\< 3 months\n* contraindications for spiro-ergometry, IAEx, or MRI'}, 'identificationModule': {'nctId': 'NCT00912561', 'acronym': 'Exercise', 'briefTitle': 'Effects of Intense Aerobic Exercise on the Cerebrovascular Reserve Capacity in Patients With Hemodynamically Relevant Intra- and Extracranial Stenoses', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Effects of Intense Aerobic Exercise on the Cerebrovascular Reserve Capacity in Patients With Hemodynamically Relevant Intra- and Extracranial Stenoses', 'orgStudyIdInfo': {'id': 'CCBF-Exercise'}, 'secondaryIdInfos': [{'id': 'EA4/106/08'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Sedentary', 'description': 'patients who train after an 8 week observational period'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'patients who train immediately after enrollment', 'description': 'patients who train immediately after enrollment', 'interventionNames': ['Behavioral: Intense aerobic exercise']}], 'interventions': [{'name': 'Intense aerobic exercise', 'type': 'BEHAVIORAL', 'description': '3 Units (of at least 30 minutes) of intense aerobic exercise per week for 8 weeks', 'armGroupLabels': ['patients who train immediately after enrollment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12200', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Centre for Stroke Research Berlin, Neurology, Charité Campus Benjamin Franklin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gerhard Jan Jungehuelsing', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Gerhard Jan Jungehuelsing', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}