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.
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: * Aerobic Training Group; * Control Group (usual care) The intervention will last 12 weeks, 3 sessions/week Pre and post-intervention assessments will include: * 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). * 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. * Cognitive performance: Montreal Cognitive Assessment (MoCA), Trail Making Test A and B, and Stroop Color-Word Test. * Gait biomechanics: spatiotemporal parameters, 3D kinematics (Vicon system), and kinetics (force platform). * 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). * Body composition: quadriceps muscle thickness and subcutaneous adipose tissue thickness assessed by ultrasound. All experimental sessions will be performed in the "on" medication state
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Aerobic Exercise Training
Usual Care
Associação Brasil Parkinson
São Paulo, São Paulo, Brazil
RECRUITINGChange in Cerebrovascular Reactivity
Breath-holding index (dimensionless) assessed by transcranial Doppler
Time frame: Baseline and 12 weeks
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.
Time frame: Baseline and 12 weeks
Change in Dynamic Cerebral Autoregulation
Transfer function gain and phase (0.02-0.4 Hz frequency bands).
Time frame: Baseline and 12 weeks
Change in Acute Cerebral Blood Flow Response to Exercise
Change in middle cerebral artery velocity during 6-minute aerobic bout.
Time frame: Baseline and 12 weeks
Change in Brachial Artery Endothelial Function
Flow-mediated dilation (FMD, %) of the brachial artery assessed by high-resolution vascular ultrasound according to current guidelines.
Time frame: Baseline and 12 weeks
Change in Brachial Artery Baseline Diameter
Resting brachial artery diameter (mm) measured by vascular ultrasound
Time frame: Baseline and 12 weeks
Change in Carotid Intima-Media Thickness
Common carotid artery intima-media thickness (mm) assessed by B-mode ultrasound.
Time frame: Baseline and 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Enrollment
40
Change in Resting Blood Pressure
Systolic and diastolic blood pressure (mmHg).
Time frame: Baseline and 12 weeks
Change in Resting Heart Rate
Heart rate (beats per minute).
Time frame: Baseline and 12 weeks
Change in SDNN
SDNN derived from beat-to-beat recordings at rest.
Time frame: Baseline and 12 weeks
Change in Low Frequency Power
Low-frequency power (ms²) derived from spectral analysis.
Time frame: Baseline and 12 weeks
Change in Cognitive Function
Assessed with Montreal Cognitive Assessment that provides a score
Time frame: Baseline and 12 weeks
Change in Executive Function and Attention
Assessed with Trail Making Test Part A and Part B (time to completion, seconds).
Time frame: Baseline and 12 weeks
Change in Non-Motor Symptoms
Assessed with Non-Motor Symptoms Scale that provides a score. Higher scores indicate greater symptom burden.
Time frame: Baseline and 12 weeks
Change in Parkinson Disease Severity
Assessed with the Unified Parkinson's Disease Rating Scale (UPDRS total score).
Time frame: Baseline and 12 weeks
Change in Anxiety Severity
Assessed with the Parkinson Anxiety Scale total score (0-48). Higher scores indicate greater anxiety severity.
Time frame: Baseline and 12 weeks
Change in Depressive Symptoms
Assessed with Geriatric Depression Scale total score (0-15). Higher scores indicate greater depressive symptom severity.
Time frame: Baseline and 12 weeks
Change in Apathy
Assessed with Apathy Inventory total score (0-12). Higher scores indicate greater apathy.
Time frame: Baseline and 12 weeks
Change in Fatigue
Parkinson Fatigue Scale total score (range: 16-80). Higher scores indicate greater fatigue severity.
Time frame: Baseline and 12 weeks
Change in Sleep Quality
Assessed with Parkinson's Disease Sleep Scale total score (0-150). Lower scores indicate worse sleep quality.
Time frame: Baseline and 12 weeks
Change in Pain
Assessed using a Numeric Rating Scale (0-10). Higher values indicate higher pain
Time frame: Baseline and 12 weeks
Change in Quality of Life
Assessed with Parkinson's Disease Questionnaire-8 (PDQ-8 total score).
Time frame: Baseline and 12 weeks
Change in Gait Speed
Gait speed (meters/second) assessed during overground walking using motion capture analysis.
Time frame: Baseline and 12 weeks
Change in Gait Kinematics
Joint angles (degrees) of hip, knee, and ankle during walking assessed by 3D motion capture.
Time frame: Baseline and 12 weeks
Change in Joint Moments During Walking
Joint moments (Nm/kg) of the hip, knee, and ankle during walking assessed using force platform analysis.
Time frame: Baseline and 12 weeks
Change in Muscle Thickness
Quadriceps muscle thickness (mm) assessed by B-mode ultrasound at standardized anatomical landmarks.
Time frame: Baseline and 12 weeks
Change in Subcutaneous Adipose Tissue Thickness
Subcutaneous fat thickness (mm) assessed by B-mode ultrasound at standardized anatomical landmarks.
Time frame: Baseline and 12 weeks
Change in RMMSD
RMSSD (ms) derived from beat-to-beat recordings at rest.
Time frame: Baseline and 12 weeks
Change in High Frequency Power
High-frequency power (ms²)derived from spectral analysis
Time frame: Baseline and 12 weeks
Change in Low Frequency/High Frequency ratio
Low-frequency/high-frequency ratio derived from spectral analysis
Time frame: Baseline and 12 weeks
Change in Cadence
Cadence (steps/minute) assessed during overground walking using motion capture analysis.
Time frame: Baseline and 12 weeks
Change in Stride Length
Stride length (meters) assessed during overground walking using motion capture analysis.
Time frame: Baseline and 12 weeks
Change in Double Support Time
Double support time (% of gait cycle) assessed during overground walking using motion capture analysis
Time frame: Baseline and 12 weeks
Change in Joint Powers During Walking
Joint powers (W/kg) of the hip, knee, and ankle during walking assessed using force platform analysis.
Time frame: Baseline and 12 weeks