PARKINSON DISEASE (Disorder)
Conditions
Keywords
aerobic training, exercise, rehabilitation, Cerebral blood flow, neurovascular, gait, cardiovascular function, cognition
Brief summary
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.
Detailed description
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
Interventions
BEHAVIORALAerobic training
Aerobic Exercise Training
BEHAVIORALUsual Care
Usual Care
Sponsors
Raphael Mendes Ritti Dias
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor will be blinded for the group of the subjects
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Parkinson's disease * Hoehn \& Yahr stages 1-3 * Stable antiparkinsonian medication for at least 4 weeks * Montreal Cognitive Assessment (MoCA) score ≥ 18 * Ability to walk independently (with or without assistive device) * Medical clearance for participation in moderate-intensity exercise
Exclusion criteria
* Change in medication * Contraindication to exercise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cerebrovascular Reactivity | Baseline and 12 weeks | Breath-holding index (dimensionless) assessed by transcranial Doppler |
| Change in Neurovascular Coupling at 12 Weeks. | Baseline and 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. |
| Change in Dynamic Cerebral Autoregulation | Baseline and 12 weeks | Transfer function gain and phase (0.02-0.4 Hz frequency bands). |
| Change in Acute Cerebral Blood Flow Response to Exercise | Baseline and 12 weeks | Change in middle cerebral artery velocity during 6-minute aerobic bout. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brachial Artery Endothelial Function | Baseline and 12 weeks | Flow-mediated dilation (FMD, %) of the brachial artery assessed by high-resolution vascular ultrasound according to current guidelines. |
| Change in Brachial Artery Baseline Diameter | Baseline and 12 weeks | Resting brachial artery diameter (mm) measured by vascular ultrasound |
| Change in Carotid Intima-Media Thickness | Baseline and 12 weeks | Common carotid artery intima-media thickness (mm) assessed by B-mode ultrasound. |
| Change in Resting Blood Pressure | Baseline and 12 weeks | Systolic and diastolic blood pressure (mmHg). |
| Change in Resting Heart Rate | Baseline and 12 weeks | Heart rate (beats per minute). |
| Change in SDNN | Baseline and 12 weeks | SDNN derived from beat-to-beat recordings at rest. |
| Change in Low Frequency Power | Baseline and 12 weeks | Low-frequency power (ms²) derived from spectral analysis. |
| Change in Cognitive Function | Baseline and 12 weeks | Assessed with Montreal Cognitive Assessment that provides a score |
| Change in Executive Function and Attention | Baseline and 12 weeks | Assessed with Trail Making Test Part A and Part B (time to completion, seconds). |
| Change in Non-Motor Symptoms | Baseline and 12 weeks | Assessed with Non-Motor Symptoms Scale that provides a score. Higher scores indicate greater symptom burden. |
| Change in Parkinson Disease Severity | Baseline and 12 weeks | Assessed with the Unified Parkinson's Disease Rating Scale (UPDRS total score). |
| Change in Anxiety Severity | Baseline and 12 weeks | Assessed with the Parkinson Anxiety Scale total score (0-48). Higher scores indicate greater anxiety severity. |
| Change in Depressive Symptoms | Baseline and 12 weeks | Assessed with Geriatric Depression Scale total score (0-15). Higher scores indicate greater depressive symptom severity. |
| Change in Apathy | Baseline and 12 weeks | Assessed with Apathy Inventory total score (0-12). Higher scores indicate greater apathy. |
| Change in Fatigue | Baseline and 12 weeks | Parkinson Fatigue Scale total score (range: 16-80). Higher scores indicate greater fatigue severity. |
| Change in Sleep Quality | Baseline and 12 weeks | Assessed with Parkinson's Disease Sleep Scale total score (0-150). Lower scores indicate worse sleep quality. |
| Change in Pain | Baseline and 12 weeks | Assessed using a Numeric Rating Scale (0-10). Higher values indicate higher pain |
| Change in Quality of Life | Baseline and 12 weeks | Assessed with Parkinson's Disease Questionnaire-8 (PDQ-8 total score). |
| Change in Gait Speed | Baseline and 12 weeks | Gait speed (meters/second) assessed during overground walking using motion capture analysis. |
| Change in Gait Kinematics | Baseline and 12 weeks | Joint angles (degrees) of hip, knee, and ankle during walking assessed by 3D motion capture. |
| Change in Joint Moments During Walking | Baseline and 12 weeks | Joint moments (Nm/kg) of the hip, knee, and ankle during walking assessed using force platform analysis. |
| Change in Muscle Thickness | Baseline and 12 weeks | Quadriceps muscle thickness (mm) assessed by B-mode ultrasound at standardized anatomical landmarks. |
| Change in Subcutaneous Adipose Tissue Thickness | Baseline and 12 weeks | Subcutaneous fat thickness (mm) assessed by B-mode ultrasound at standardized anatomical landmarks. |
| Change in RMMSD | Baseline and 12 weeks | RMSSD (ms) derived from beat-to-beat recordings at rest. |
| Change in High Frequency Power | Baseline and 12 weeks | High-frequency power (ms²)derived from spectral analysis |
| Change in Low Frequency/High Frequency ratio | Baseline and 12 weeks | Low-frequency/high-frequency ratio derived from spectral analysis |
| Change in Cadence | Baseline and 12 weeks | Cadence (steps/minute) assessed during overground walking using motion capture analysis. |
| Change in Stride Length | Baseline and 12 weeks | Stride length (meters) assessed during overground walking using motion capture analysis. |
| Change in Double Support Time | Baseline and 12 weeks | Double support time (% of gait cycle) assessed during overground walking using motion capture analysis |
| Change in Joint Powers During Walking | Baseline and 12 weeks | Joint powers (W/kg) of the hip, knee, and ankle during walking assessed using force platform analysis. |
Countries
Brazil
Contacts
CONTACTRaphael M Ritti-Dias, PhD
CONTACTHélcio Kanegusuku, PhD
PRINCIPAL_INVESTIGATORRaphael M Ritti-Dias, PhD
University of Nove de Julho
Outcome results
None listed