About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Change in medication
Contraindication to exercise
Trial design
Parallel
Treatments tested in this trial
Aerobic training
BehavioralAerobic Exercise Training
Usual Care
BehavioralUsual Care
Treatment groups
Trial outcomes
Primary outcomes
Change in Cerebrovascular Reactivity
Breath-holding index (dimensionless) assessed by transcranial Doppler
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.
Change in Dynamic Cerebral Autoregulation
Transfer function gain and phase (0.02-0.4 Hz frequency bands).
Change in Acute Cerebral Blood Flow Response to Exercise
Change in middle cerebral artery velocity during 6-minute aerobic bout.
Secondary outcomes
Change in Brachial Artery Endothelial Function
Flow-mediated dilation (FMD, %) of the brachial artery assessed by high-resolution vascular ultrasound according to current guidelines.
Change in Brachial Artery Baseline Diameter
Resting brachial artery diameter (mm) measured by vascular ultrasound
Change in Carotid Intima-Media Thickness
Common carotid artery intima-media thickness (mm) assessed by B-mode ultrasound.
Change in Resting Blood Pressure
Systolic and diastolic blood pressure (mmHg).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Raphael Mendes Ritti Dias
Lead sponsor
University of Nove de Julho
Sponsor institution