Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
The intervention will last 12 weeks, 3 sessions/week Pre and post-intervention assessments will include:
All experimental sessions will be performed in the "on" medication state
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual Care | Other | Participants will maintain their usual clinical care and daily activities without structured exercise intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic training | Behavioral | Aerobic Exercise Training |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cerebrovascular Reactivity | Breath-holding index (dimensionless) assessed by transcranial Doppler | 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. | Baseline and 12 weeks |
| Change in Dynamic Cerebral Autoregulation | Transfer function gain and phase (0.02-0.4 Hz frequency bands). | Baseline and 12 weeks |
| Change in Acute Cerebral Blood Flow Response to Exercise | Change in middle cerebral artery velocity during 6-minute aerobic bout. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brachial Artery Endothelial Function | Flow-mediated dilation (FMD, %) of the brachial artery assessed by high-resolution vascular ultrasound according to current guidelines. | Baseline and 12 weeks |
| Change in Brachial Artery Baseline Diameter |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raphael M Ritti-Dias, PhD | Contact | +5519999406878 | raphaelritti@gmail.com | |
| Hélcio Kanegusuku, PhD | Contact | +55 11 99539-9557 | helciokng@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Raphael M Ritti-Dias, PhD | University of Nove de Julho | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associação Brasil Parkinson | Recruiting | São Paulo | São Paulo | 04142-092 | Brazil |
Anonymized datasets will be avaliable after the completion of the study and publication of main results
Not provided
6 months after the publication
Open acess
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Outcomes assessor will be blinded for the group of the subjects
| Usual Care |
| Behavioral |
Usual Care |
|
Resting brachial artery diameter (mm) measured by vascular ultrasound |
| Baseline and 12 weeks |
| Change in Carotid Intima-Media Thickness | Common carotid artery intima-media thickness (mm) assessed by B-mode ultrasound. | Baseline and 12 weeks |
| Change in Resting Blood Pressure | Systolic and diastolic blood pressure (mmHg). | Baseline and 12 weeks |
| Change in Resting Heart Rate | Heart rate (beats per minute). | Baseline and 12 weeks |
| Change in SDNN | SDNN derived from beat-to-beat recordings at rest. | Baseline and 12 weeks |
| Change in Low Frequency Power | Low-frequency power (ms²) derived from spectral analysis. | Baseline and 12 weeks |
| Change in Cognitive Function | Assessed with Montreal Cognitive Assessment that provides a score | Baseline and 12 weeks |
| Change in Executive Function and Attention | Assessed with Trail Making Test Part A and Part B (time to completion, seconds). | 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. | Baseline and 12 weeks |
| Change in Parkinson Disease Severity | Assessed with the Unified Parkinson's Disease Rating Scale (UPDRS total score). | Baseline and 12 weeks |
| Change in Anxiety Severity | Assessed with the Parkinson Anxiety Scale total score (0-48). Higher scores indicate greater anxiety severity. | Baseline and 12 weeks |
| Change in Depressive Symptoms | Assessed with Geriatric Depression Scale total score (0-15). Higher scores indicate greater depressive symptom severity. | Baseline and 12 weeks |
| Change in Apathy | Assessed with Apathy Inventory total score (0-12). Higher scores indicate greater apathy. | Baseline and 12 weeks |
| Change in Fatigue | Parkinson Fatigue Scale total score (range: 16-80). Higher scores indicate greater fatigue severity. | 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. | Baseline and 12 weeks |
| Change in Pain | Assessed using a Numeric Rating Scale (0-10). Higher values indicate higher pain | Baseline and 12 weeks |
| Change in Quality of Life | Assessed with Parkinson's Disease Questionnaire-8 (PDQ-8 total score). | Baseline and 12 weeks |
| Change in Gait Speed | Gait speed (meters/second) assessed during overground walking using motion capture analysis. | Baseline and 12 weeks |
| Change in Gait Kinematics | Joint angles (degrees) of hip, knee, and ankle during walking assessed by 3D motion capture. | 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. | Baseline and 12 weeks |
| Change in Muscle Thickness | Quadriceps muscle thickness (mm) assessed by B-mode ultrasound at standardized anatomical landmarks. | Baseline and 12 weeks |
| Change in Subcutaneous Adipose Tissue Thickness | Subcutaneous fat thickness (mm) assessed by B-mode ultrasound at standardized anatomical landmarks. | Baseline and 12 weeks |
| Change in RMMSD | RMSSD (ms) derived from beat-to-beat recordings at rest. | Baseline and 12 weeks |
| Change in High Frequency Power | High-frequency power (ms²)derived from spectral analysis | Baseline and 12 weeks |
| Change in Low Frequency/High Frequency ratio | Low-frequency/high-frequency ratio derived from spectral analysis | Baseline and 12 weeks |
| Change in Cadence | Cadence (steps/minute) assessed during overground walking using motion capture analysis. | Baseline and 12 weeks |
| Change in Stride Length | Stride length (meters) assessed during overground walking using motion capture analysis. | Baseline and 12 weeks |
| Change in Double Support Time | Double support time (% of gait cycle) assessed during overground walking using motion capture analysis | 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. | Baseline and 12 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001519 | Behavior |