NCT07478146

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Feb 2026Dec 2027

First Submitted

Initial submission to the registry

February 27, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

February 28, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

February 27, 2026

Last Update Submit

April 6, 2026

Conditions

PARKINSON DISEASE (Disorder)

Keywords

aerobic trainingexerciserehabilitationCerebral blood flowneurovasculargaitcardiovascular functioncognition

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (30)

  • Change in Brachial Artery Endothelial Function

    Baseline and 12 weeks

  • Change in Brachial Artery Baseline Diameter

    Baseline and 12 weeks

  • Change in Carotid Intima-Media Thickness

    Baseline and 12 weeks

  • Change in Resting Blood Pressure

    Baseline and 12 weeks

  • Change in Resting Heart Rate

    Baseline and 12 weeks

  • +25 more secondary outcomes

Study Arms (2)

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.

Behavioral: Aerobic training

Usual Care

OTHER

Participants will maintain their usual clinical care and daily activities without structured exercise intervention.

Behavioral: Usual Care

Interventions

Usual CareBEHAVIORAL

Usual Care

Usual Care
Aerobic trainingBEHAVIORAL

Aerobic Exercise Training

Aerobic Training

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Change in medication
  • Contraindication to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Associação Brasil Parkinson

São Paulo, São Paulo, 04142-092, Brazil

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Study Officials

  • Raphael M Ritti-Dias, PhD

    University of Nove de Julho

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raphael M Ritti-Dias, PhD

CONTACT

+5519999406878raphaelritti@gmail.com

Hélcio Kanegusuku, PhD

CONTACT

+55 11 99539-9557helciokng@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessor will be blinded for the group of the subjects
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 17, 2026

Study Start

February 28, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Anonymized datasets will be avaliable after the completion of the study and publication of main results

Time Frame
6 months after the publication
Access Criteria
Open acess

Locations

BR(1)