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NCT Number: NCT07478146

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

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.

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Key information

Conditions

PARKINSON DISEASE (Disorder) Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Motor Activity Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic training

Behavioral

Aerobic Exercise Training

Usual Care

Behavioral

Usual Care

Primary outcomes

  1. Change in Cerebrovascular Reactivity

    Time frame: Baseline and 12 weeks

    Breath-holding index (dimensionless) assessed by transcranial Doppler

  2. Change in Neurovascular Coupling at 12 Weeks.

    Time frame: 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.

  3. Change in Dynamic Cerebral Autoregulation

    Time frame: Baseline and 12 weeks

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

  4. Change in Acute Cerebral Blood Flow Response to Exercise

    Time frame: Baseline and 12 weeks

    Change in middle cerebral artery velocity during 6-minute aerobic bout.

Secondary outcomes

  1. Change in Brachial Artery Endothelial Function

    Time frame: Baseline and 12 weeks

    Flow-mediated dilation (FMD, %) of the brachial artery assessed by high-resolution vascular ultrasound according to current guidelines.

  2. Change in Brachial Artery Baseline Diameter

    Time frame: Baseline and 12 weeks

    Resting brachial artery diameter (mm) measured by vascular ultrasound

  3. Change in Carotid Intima-Media Thickness

    Time frame: Baseline and 12 weeks

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

  4. Change in Resting Blood Pressure

    Time frame: Baseline and 12 weeks

    Systolic and diastolic blood pressure (mmHg).

  5. Change in Resting Heart Rate

    Time frame: Baseline and 12 weeks

    Heart rate (beats per minute).

  6. Change in SDNN

    Time frame: Baseline and 12 weeks

    SDNN derived from beat-to-beat recordings at rest.

  7. Change in Low Frequency Power

    Time frame: Baseline and 12 weeks

    Low-frequency power (ms²) derived from spectral analysis.

  8. Change in Cognitive Function

    Time frame: Baseline and 12 weeks

    Assessed with Montreal Cognitive Assessment that provides a score

  9. Change in Executive Function and Attention

    Time frame: Baseline and 12 weeks

    Assessed with Trail Making Test Part A and Part B (time to completion, seconds).

  10. Change in Non-Motor Symptoms

    Time frame: Baseline and 12 weeks

    Assessed with Non-Motor Symptoms Scale that provides a score. Higher scores indicate greater symptom burden.

  11. Change in Parkinson Disease Severity

    Time frame: Baseline and 12 weeks

    Assessed with the Unified Parkinson's Disease Rating Scale (UPDRS total score).

  12. Change in Anxiety Severity

    Time frame: Baseline and 12 weeks

    Assessed with the Parkinson Anxiety Scale total score (0-48). Higher scores indicate greater anxiety severity.

  13. Change in Depressive Symptoms

    Time frame: Baseline and 12 weeks

    Assessed with Geriatric Depression Scale total score (0-15). Higher scores indicate greater depressive symptom severity.

  14. Change in Apathy

    Time frame: Baseline and 12 weeks

    Assessed with Apathy Inventory total score (0-12). Higher scores indicate greater apathy.

  15. Change in Fatigue

    Time frame: Baseline and 12 weeks

    Parkinson Fatigue Scale total score (range: 16-80). Higher scores indicate greater fatigue severity.

  16. Change in Sleep Quality

    Time frame: Baseline and 12 weeks

    Assessed with Parkinson's Disease Sleep Scale total score (0-150). Lower scores indicate worse sleep quality.

  17. Change in Pain

    Time frame: Baseline and 12 weeks

    Assessed using a Numeric Rating Scale (0-10). Higher values indicate higher pain

  18. Change in Quality of Life

    Time frame: Baseline and 12 weeks

    Assessed with Parkinson's Disease Questionnaire-8 (PDQ-8 total score).

  19. Change in Gait Speed

    Time frame: Baseline and 12 weeks

    Gait speed (meters/second) assessed during overground walking using motion capture analysis.

  20. Change in Gait Kinematics

    Time frame: Baseline and 12 weeks

    Joint angles (degrees) of hip, knee, and ankle during walking assessed by 3D motion capture.

  21. Change in Joint Moments During Walking

    Time frame: Baseline and 12 weeks

    Joint moments (Nm/kg) of the hip, knee, and ankle during walking assessed using force platform analysis.

  22. Change in Muscle Thickness

    Time frame: Baseline and 12 weeks

    Quadriceps muscle thickness (mm) assessed by B-mode ultrasound at standardized anatomical landmarks.

  23. Change in Subcutaneous Adipose Tissue Thickness

    Time frame: Baseline and 12 weeks

    Subcutaneous fat thickness (mm) assessed by B-mode ultrasound at standardized anatomical landmarks.

  24. Change in RMMSD

    Time frame: Baseline and 12 weeks

    RMSSD (ms) derived from beat-to-beat recordings at rest.

  25. Change in High Frequency Power

    Time frame: Baseline and 12 weeks

    High-frequency power (ms²)derived from spectral analysis

  26. Change in Low Frequency/High Frequency ratio

    Time frame: Baseline and 12 weeks

    Low-frequency/high-frequency ratio derived from spectral analysis

  27. Change in Cadence

    Time frame: Baseline and 12 weeks

    Cadence (steps/minute) assessed during overground walking using motion capture analysis.

  28. Change in Stride Length

    Time frame: Baseline and 12 weeks

    Stride length (meters) assessed during overground walking using motion capture analysis.

  29. Change in Double Support Time

    Time frame: Baseline and 12 weeks

    Double support time (% of gait cycle) assessed during overground walking using motion capture analysis

  30. Change in Joint Powers During Walking

    Time frame: Baseline and 12 weeks

    Joint powers (W/kg) of the hip, knee, and ankle during walking assessed using force platform analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Hélcio Kanegusuku, PhD

CONTACT

[email protected]

+55 11 99539-9557

Raphael M Ritti-Dias, PhD

CONTACT

[email protected]

+5519999406878

Sponsors and collaborators

Lead sponsor

Raphael Mendes Ritti Dias

Other

Registry information

Official study title

Effects of Aerobic Training on Cerebrovascular Function, Cognitive Performance and Gait Parameters in Patients With Parkinson's Disease: A Randomized Controlled Trial

Acronym: CardioParkinso

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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