Brief Title: Aerobic Training on Cerebrovascular Function, Cognition and Gait in Parkinson's Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorRaphael Mendes Ritti Dias

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Aerobic training

    Behavioral

    Aerobic Exercise Training

  • Usual Care

    Behavioral

    Usual Care

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Aerobic TrainingExperimental treatment 1 intervention
Group B: Usual CareOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in Cerebrovascular Reactivity

Breath-holding index (dimensionless) assessed by transcranial Doppler

Time frame
Baseline and 12 weeks
2

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
3

Change in Dynamic Cerebral Autoregulation

Transfer function gain and phase (0.02-0.4 Hz frequency bands).

Time frame
Baseline and 12 weeks
4

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

Secondary outcomes

1

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
2

Change in Brachial Artery Baseline Diameter

Resting brachial artery diameter (mm) measured by vascular ultrasound

Time frame
Baseline and 12 weeks
3

Change in Carotid Intima-Media Thickness

Common carotid artery intima-media thickness (mm) assessed by B-mode ultrasound.

Time frame
Baseline and 12 weeks
4

Change in Resting Blood Pressure

Systolic and diastolic blood pressure (mmHg).

Time frame
Baseline and 12 weeks

Other outcomes

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