[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629705":3},{"organization":4,"outcomesModule":7,"designInfo":114,"detailedDescription":123,"studyPopulation":113,"armGroups":124,"interventions":136,"overallOfficials":144,"centralContacts":148,"locations":157,"responsibleParty":176,"collaborators":113,"id":180,"slug":113,"hasResults":181,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":181,"sex":187,"minAge":188,"maxAge":113,"enrollmentInfo":189,"targetDuration":113,"studyType":192,"phases":193,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":160,"whyStopped":113,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},{"fullName":5,"class":6},"University of Nove de Julho","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":113},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Change in Cerebrovascular Reactivity","Breath-holding index (dimensionless) assessed by transcranial Doppler","Baseline and 12 weeks",{"measure":14,"description":15,"timeFrame":12},"Change in Neurovascular Coupling at 12 Weeks.","Measured by relative (%) changes in middle cerebral artery blood flow velocity during standardized cognitive tasks (Stroop Color-Word Test, Trail Making Test A and B, and silent reading protocol) using transcranial Doppler ultrasound.",{"measure":17,"description":18,"timeFrame":12},"Change in Dynamic Cerebral Autoregulation","Transfer function gain and phase (0.02-0.4 Hz frequency bands).",{"measure":20,"description":21,"timeFrame":12},"Change in Acute Cerebral Blood Flow Response to Exercise","Change in middle cerebral artery velocity during 6-minute aerobic bout.",[23,26,29,32,35,38,41,44,47,50,53,56,59,62,65,68,71,74,77,80,83,86,89,92,95,98,101,104,107,110],{"measure":24,"description":25,"timeFrame":12},"Change in Brachial Artery Endothelial Function","Flow-mediated dilation (FMD, %) of the brachial artery assessed by high-resolution vascular ultrasound according to current guidelines.",{"measure":27,"description":28,"timeFrame":12},"Change in Brachial Artery Baseline Diameter","Resting brachial artery diameter (mm) measured by vascular ultrasound",{"measure":30,"description":31,"timeFrame":12},"Change in Carotid Intima-Media Thickness","Common carotid artery intima-media thickness (mm) assessed by B-mode ultrasound.",{"measure":33,"description":34,"timeFrame":12},"Change in Resting Blood Pressure","Systolic and diastolic blood pressure (mmHg).",{"measure":36,"description":37,"timeFrame":12},"Change in Resting Heart Rate","Heart rate (beats per minute).",{"measure":39,"description":40,"timeFrame":12},"Change in SDNN","SDNN derived from beat-to-beat recordings at rest.",{"measure":42,"description":43,"timeFrame":12},"Change in Low Frequency Power","Low-frequency power (ms²) derived from spectral analysis.",{"measure":45,"description":46,"timeFrame":12},"Change in Cognitive Function","Assessed with Montreal Cognitive Assessment that provides a score",{"measure":48,"description":49,"timeFrame":12},"Change in Executive Function and Attention","Assessed with Trail Making Test Part A and Part B (time to completion, seconds).",{"measure":51,"description":52,"timeFrame":12},"Change in Non-Motor Symptoms","Assessed with Non-Motor Symptoms Scale that provides a score. Higher scores indicate greater symptom burden.",{"measure":54,"description":55,"timeFrame":12},"Change in Parkinson Disease Severity","Assessed with the Unified Parkinson's Disease Rating Scale (UPDRS total score).",{"measure":57,"description":58,"timeFrame":12},"Change in Anxiety Severity","Assessed with the Parkinson Anxiety Scale total score (0-48). Higher scores indicate greater anxiety severity.",{"measure":60,"description":61,"timeFrame":12},"Change in Depressive Symptoms","Assessed with Geriatric Depression Scale total score (0-15). Higher scores indicate greater depressive symptom severity.",{"measure":63,"description":64,"timeFrame":12},"Change in Apathy","Assessed with Apathy Inventory total score (0-12). Higher scores indicate greater apathy.",{"measure":66,"description":67,"timeFrame":12},"Change in Fatigue","Parkinson Fatigue Scale total score (range: 16-80). Higher scores indicate greater fatigue severity.",{"measure":69,"description":70,"timeFrame":12},"Change in Sleep Quality","Assessed with Parkinson's Disease Sleep Scale total score (0-150). Lower scores indicate worse sleep quality.",{"measure":72,"description":73,"timeFrame":12},"Change in Pain","Assessed using a Numeric Rating Scale (0-10). Higher values indicate higher pain",{"measure":75,"description":76,"timeFrame":12},"Change in Quality of Life","Assessed with Parkinson's Disease Questionnaire-8 (PDQ-8 total score).",{"measure":78,"description":79,"timeFrame":12},"Change in Gait Speed","Gait speed (meters\u002Fsecond) assessed during overground walking using motion capture analysis.",{"measure":81,"description":82,"timeFrame":12},"Change in Gait Kinematics","Joint angles (degrees) of hip, knee, and ankle during walking assessed by 3D motion capture.",{"measure":84,"description":85,"timeFrame":12},"Change in Joint Moments During Walking","Joint moments (Nm\u002Fkg) of the hip, knee, and ankle during walking assessed using force platform analysis.",{"measure":87,"description":88,"timeFrame":12},"Change in Muscle Thickness","Quadriceps muscle thickness (mm) assessed by B-mode ultrasound at standardized anatomical landmarks.",{"measure":90,"description":91,"timeFrame":12},"Change in Subcutaneous Adipose Tissue Thickness","Subcutaneous fat thickness (mm) assessed by B-mode ultrasound at standardized anatomical landmarks.",{"measure":93,"description":94,"timeFrame":12},"Change in RMMSD","RMSSD (ms) derived from beat-to-beat recordings at rest.",{"measure":96,"description":97,"timeFrame":12},"Change in High Frequency Power","High-frequency power (ms²)derived from spectral analysis",{"measure":99,"description":100,"timeFrame":12},"Change in Low Frequency\u002FHigh Frequency ratio","Low-frequency\u002Fhigh-frequency ratio derived from spectral analysis",{"measure":102,"description":103,"timeFrame":12},"Change in Cadence","Cadence (steps\u002Fminute) assessed during overground walking using motion capture analysis.",{"measure":105,"description":106,"timeFrame":12},"Change in Stride Length","Stride length (meters) assessed during overground walking using motion capture analysis.",{"measure":108,"description":109,"timeFrame":12},"Change in Double Support Time","Double support time (% of gait cycle) assessed during overground walking using motion capture analysis",{"measure":111,"description":112,"timeFrame":12},"Change in Joint Powers During Walking","Joint powers (W\u002Fkg) of the hip, knee, and ankle during walking assessed using force platform analysis.",null,{"allocation":115,"interventionModel":116,"interventionModelDescription":113,"primaryPurpose":117,"observationalModel":113,"timePerspective":113,"maskingInfo":118},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":119,"maskingDescription":120,"whoMasked":121},"SINGLE","Outcomes assessor will be blinded for the group of the subjects",[122],"OUTCOMES_ASSESSOR","This is a parallel-group randomized controlled trial Participants (n=40) diagnosed with Parkinson's disease, stages 1-3 on Hoehn \\& Yahr scale, will be randomly allocated (1:1 block randomization) to:\n\n* Aerobic Training Group;\n* Control Group (usual care)\n\nThe intervention will last 12 weeks, 3 sessions\u002Fweek Pre and post-intervention assessments will include:\n\n* Cerebrovascular function: neurovascular coupling, cerebrovascular reactivity (breath-holding index), dynamic cerebral autoregulation (transfer function analysis), and acute cerebral blood flow response to exercise (transcranial Doppler; vertebral artery flow during silent reading).\n* Peripheral vascular and cardiovascular function: brachial artery flow-mediated dilation, carotid intima-media thickness, resting blood pressure, resting heart rate, cardiorespiratory fitness (VO₂peak), heart rate variability (time and frequency domains), and baroreflex sensitivity.\n* Cognitive performance: Montreal Cognitive Assessment (MoCA), Trail Making Test A and B, and Stroop Color-Word Test.\n* Gait biomechanics: spatiotemporal parameters, 3D kinematics (Vicon system), and kinetics (force platform).\n* Clinical and non-motor symptoms: UPDRS, Non-Motor Symptoms Scale (NMSS), sleep quality (PDSS), anxiety (PAS), depressive symptoms (GDS-15), apathy (Apathy Inventory), fatigue (Parkinson Fatigue Scale), pain (Numeric Rating Scale), and quality of life (PDQ-8).\n* Body composition: quadriceps muscle thickness and subcutaneous adipose tissue thickness assessed by ultrasound.\n\nAll experimental sessions will be performed in the \"on\" medication state",[125,131],{"label":126,"type":127,"description":128,"interventionNames":129},"Aerobic Training","EXPERIMENTAL","Participants will perform supervised aerobic training on a cycle ergometer, 3 times per week for 12 weeks, 40 minutes per session, at perceived exertion 12-13 on Borg scale.",[130],"Behavioral: Aerobic training",{"label":132,"type":6,"description":133,"interventionNames":134},"Usual Care","Participants will maintain their usual clinical care and daily activities without structured exercise intervention.",[135],"Behavioral: Usual Care",[137,142],{"type":138,"name":139,"description":140,"armGroupLabels":141,"otherNames":113},"BEHAVIORAL","Aerobic training","Aerobic Exercise Training",[126],{"type":138,"name":132,"description":132,"armGroupLabels":143,"otherNames":113},[132],[145],{"name":146,"affiliation":5,"role":147},"Raphael M Ritti-Dias, PhD","PRINCIPAL_INVESTIGATOR",[149,153],{"name":146,"role":150,"phone":151,"phoneExt":113,"email":152},"CONTACT","+5519999406878","raphaelritti@gmail.com",{"name":154,"role":150,"phone":155,"phoneExt":113,"email":156},"Hélcio Kanegusuku, PhD","+55 11 99539-9557","helciokng@gmail.com",[158],{"facility":159,"status":160,"city":161,"state":161,"zip":162,"country":163,"countryCode":164,"cosmosGeoPoint":165,"geoPoint":170,"contacts":171},"Associação Brasil Parkinson","RECRUITING","São Paulo","04142-092","Brazil","BR",{"type":166,"coordinates":167},"Point",[168,169],-46.63611,-23.5475,{"lat":169,"lon":168},[172],{"name":173,"role":150,"phone":174,"phoneExt":113,"email":175},"Verônica Souza, MD","+55 11 97445-9125","veronica.souza82@yahoo.com.br",{"type":177,"investigatorFullName":178,"investigatorTitle":179,"investigatorAffiliation":5,"oldNameTitle":113,"oldOrganization":113},"SPONSOR_INVESTIGATOR","Raphael Mendes Ritti Dias","Professor","100629705",false,"NCT07478146","Brief Title: Aerobic Training on Cerebrovascular Function, Cognition and Gait in Parkinson's Disease","Effects of Aerobic Training on Cerebrovascular Function, Cognitive Performance and Gait Parameters in Patients With Parkinson's Disease: A Randomized Controlled Trial","CardioParkinso","Inclusion Criteria:\n\n* Clinical diagnosis of Parkinson's disease\n* Hoehn \\& Yahr stages 1-3\n* Stable antiparkinsonian medication for at least 4 weeks\n* Montreal Cognitive Assessment (MoCA) score ≥ 18\n* Ability to walk independently (with or without assistive device)\n* Medical clearance for participation in moderate-intensity exercise\n\nExclusion Criteria:\n\n* Change in medication\n* Contraindication to exercise","ALL","40 Years",{"count":190,"type":191},40,"ESTIMATED","INTERVENTIONAL",[194],"NA","This randomized controlled trial will investigate the effects of a 12-week supervised aerobic training program on cerebrovascular function, peripheral vascular health, cardiovascular autonomic modulation, cognition, non-motor symptoms, sleep, mood, gait biomechanics, quality of life, and body composition in patients with Parkinson's disease (Hoehn \\& Yahr stages 1-3). Participants will be randomly allocated to aerobic training or usual care.",[197],"PARKINSON DISEASE (Disorder)",[199,200,201,202,203,204,205,206],"aerobic training","exercise","rehabilitation","Cerebral blood flow","neurovascular","gait","cardiovascular function","cognition","2026-04-06",{"date":209,"type":210},"2026-04-13","ACTUAL",{"date":212,"type":210},"2026-02-28",{"date":214,"type":191},"2027-12-31",{"name":178,"class":6},1]