Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT05584605
Status:
UNKNOWN
Last Update Posted:
2022-10-18
First Post:
2022-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perfusion Augmentation Through Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052580', 'term': 'Muscle Stretching Exercises'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-13', 'studyFirstSubmitDate': '2022-09-15', 'studyFirstSubmitQcDate': '2022-10-13', 'lastUpdatePostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Concomitant medications', 'timeFrame': 'post-intervention (12 weeks) + follow-up (+3 months)', 'description': 'covariate'}], 'primaryOutcomes': [{'measure': 'Brain imaging - cerebrovascular reactivity (CVR) by BOLD-fMRI', 'timeFrame': 'post-intervention (12 weeks)', 'description': 'Functional brain tissue perfusion and tissue at risk based on cerebrovascular reactivity by blood oxygenation-level dependent functional magnetic resonance imaging (BOLD-fMRI), measured as the percentage BOLD signal change /mmHg CO2.'}], 'secondaryOutcomes': [{'measure': 'Brain imaging - intravoxel incoherent motion (IVIM)', 'timeFrame': 'post-intervention (12 weeks)', 'description': 'Functionality of brain microvasculature by measuring diffusion and perfusion components of tissue based on intravoxel incoherent motion'}, {'measure': 'Brain imaging - NOVA-qMRI', 'timeFrame': 'post-intervention (12 weeks)', 'description': 'Blood flow velocity based on non-invasive optimal vessel analysis quantitative magnetic resonance imaging'}, {'measure': 'Brain imaging - Lesion volume', 'timeFrame': 'post-intervention (12 weeks)', 'description': 'based on 3D T1 weighted imaging, 3D Fluid-Attenuated Inversion Recovery (FLAIR), Diffusion-Eighted Imaging (DWI)'}, {'measure': 'Brain imaging - Collateral status', 'timeFrame': 'post-intervention (12 weeks)', 'description': 'Collateral status based on 3D time of flight angiography (TOF)'}, {'measure': 'Exercise stress testing', 'timeFrame': 'post-intervention (12 weeks)', 'description': 'Cycle ergometer testing with spirometry'}, {'measure': 'Six-Minute Walk Test (6MWT)', 'timeFrame': 'post-intervention (12 weeks) + follow-up (+3 months)', 'description': 'Functional walking capacity in meters'}, {'measure': 'Ten-Meter Walk Test (10MWT)', 'timeFrame': 'post-intervention (12 weeks) + follow-up (+3 months)', 'description': 'Walking speed in m/s'}, {'measure': 'Fugl-Meyer Assessment of the Lower Extremity (FMMA-LE)', 'timeFrame': 'post-intervention (12 weeks) + follow-up (+3 months)', 'description': 'Stroke-specific motor impairment index to assess lower limb motor function with a total score ranging from 0 to 34 and higher scores indicating better performance.'}, {'measure': 'Motricity Index of the Lower Extremity (MI-LE)', 'timeFrame': 'post-intervention (12 weeks) + follow-up (+3 months)', 'description': 'Muscle strength assessment of three major muscle groups of the lower extremity with a total score ranging from 0 to 100 and higher scores indicating better performance.'}, {'measure': '5-Chair-Rise-Test', 'timeFrame': 'post-intervention (12 weeks) + follow-up (+3 months)', 'description': 'Functional muscle strength, measured in seconds to complete the task.'}, {'measure': 'International Physical Activity Questionnaire (IPAQ)', 'timeFrame': 'post-intervention (12 weeks) + follow-up (+3 months)', 'description': 'self-reported physical activity'}, {'measure': 'Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'post-intervention (12 weeks) + follow-up (+3 months)', 'description': 'Screening assessment of cognitive functions with a maximum score of 30 points.'}, {'measure': 'Word list learning', 'timeFrame': 'post-intervention (12 weeks) + follow-up (+3 months)', 'description': 'Assessment of memory function'}, {'measure': 'Digit Span Test / Corsi block', 'timeFrame': 'post-intervention (12 weeks) + follow-up (+3 months)', 'description': 'Assessment verbal and nonverbal working memory'}, {'measure': 'Stroop test', 'timeFrame': 'post-intervention (12 weeks) + follow-up (+3 months)', 'description': 'Assessment of executive function and inhibition'}, {'measure': 'European Quality of Life 5 Dimensions 5 Level (5Q-5D-5L)', 'timeFrame': 'post-intervention (12 weeks) + follow-up (+3 months)', 'description': 'Quality of life questionnaire that assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) on a 5-level scale ranging from 1 - no, 2 - slight, 3 - moderate, 4 - severe to 5 - extreme problems or unstable to.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cerebral perfusion', 'aerobic exercise'], 'conditions': ['Stroke, Ischemic']}, 'descriptionModule': {'briefSummary': 'Large cerebral vessel occlusion is a common phenomenon in the general population and accounts for 13-35% of ischemic strokes. Chronic stenosis in the large cerebral arteries is associated with cerebral hypoperfusion, cognitive decline and an increased risk of stroke or recurrent stroke, respectively.\n\nEven with upgrowth of surgical or endovascular interventions, mechanical reopening of the occluded vessels is often not possible. Alternative treatment opportunities include minimal-to-moderate blood pressure elevation (typically by ceasing antihypertensives) waiting for collateral circulation to develop spontaneously. Another conservative approach to increase cerebral perfusion is aerobic exercising. Physical activity has shown to lead to cerebral blood flow increase, especially in activated brain areas of healthy human and rat models. However, it is remains unknown, how physiological adaptation to physical activity expresses in persons after stroke due to large vessel occlusion. Herein, it is hypothesized that aerobic exercise facilitates the development of an extensive and functional vascular collateral network in persons with ischemic stroke and perfusion compromise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and Female patients of 18 years of age or above\n* Subjects after ischemic cerebral stroke (≥ 3 months) due to large vessel occlusion\n* Subjects do not qualify for flow augmentation through ECIC bypass or endovascular treatment\n* Persistent deficit in BOLD-CVR\n* Functional Ambulatory Categories \\>2\n* Discharged from hospitalization / inpatient rehabilitation\n* Living independent before stroke (mRS ≤3)\n* Written Informed Consent\n\nExclusion Criteria:\n\n* Severe cardiac disease, such as instable angina pectoris, pericarditis, heart failure (New York Health Association \\> II°), or hemodynamically significant valvular dysfunction\n* Complete arterial stenosis\n* Peripheral artery disease with mild to moderate claudication at \\< 200m or 200-1000m of walking\n* Contra-indication, such as a history of a seizure, prior electroconvulsive therapy, deep brain stimulators or other metal in the head, skull defect, pacemaker, neuroleptic medication\n* Inability to follow the procedures of the study, e.g., due to language problems (unable to follow to stage commands), psychological disorders (major depression), and / or a neurodegenerative disease (dementia)\n* Known or suspected non-compliance, documented drug, or alcohol abuse\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05584605', 'acronym': 'PERFEX', 'briefTitle': 'Perfusion Augmentation Through Exercise', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Changes in PERFusion and Cerebrovascular Reactivity Through Aerobic EXercise Training After Ischemic Stroke - a Proof of Concept Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2022-00438'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'aerobic treadmill training', 'description': 'Progressive graded, high-intensity aerobic treadmill training is delivered over 36 sessions at a frequency of 3x per week for 30-50 minutes of training per session over a period of 3 months. If possible, the training intensity is progressed from 40% to 80% of heart rate reserve, according to the supervising therapist.', 'interventionNames': ['Behavioral: Aerobic treadmill training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'stretching exercise', 'description': 'The control intervention includes stretching exercise therapy similarly heart rate controlled within limits up to 20% of heart rate reserve over 36 sessions at a frequency of 3x per week for 30 minutes.', 'interventionNames': ['Behavioral: Stretching exercise']}], 'interventions': [{'name': 'Aerobic treadmill training', 'type': 'BEHAVIORAL', 'description': 'The intervention will be delivered based on the initial exercise testing and graded based by increasing the duration, speed and/or altitude of the treadmill training.', 'armGroupLabels': ['aerobic treadmill training']}, {'name': 'Stretching exercise', 'type': 'BEHAVIORAL', 'description': 'Interventions, such as stretching, relaxation, passive soft-tissue technics (excl. manipulation) that do not elevate the heart rate above 20HRR', 'armGroupLabels': ['stretching exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Ambulante Reha Triemli Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'city': 'Zurich', 'country': 'Switzerland', 'contacts': [{'name': 'Bartosz Bujan, MD', 'role': 'CONTACT', 'email': 'bartosz.bujan@kliniklengg.ch', 'phone': '+41443876767'}], 'facility': 'Klinik Lengg AG', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'city': 'Zurich', 'country': 'Switzerland', 'contacts': [{'name': 'Christoph Globas, MD', 'role': 'CONTACT', 'email': 'christoph.globas@usz.ch', 'phone': '+41442555511'}], 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Anne Schwarz, PhD', 'role': 'CONTACT', 'email': 'anne.schwarz@usz.ch', 'phone': '+41442555645'}], 'overallOfficials': [{'name': 'Christoph Globas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital and University of Zurich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}