PARKINSON DISEASE (Disorder)CardioParkinsoNCT07478146
Brief Title: Aerobic Training on Cerebrovascular Function, Cognition and Gait in Parkinson's Disease
A study testing Aerobic training in people with PARKINSON DISEASE (Disorder), run by Raphael Mendes Ritti Dias at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- Aerobic training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Feb 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Change in medication
- Contraindication to exercise
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Associação Brasil Parkinson
São Paulo, São Paulo, 04142-092
Verônica Souza, MD, +55 11 97445-9125, veronica.souza82@yahoo.com.br
About this study
Official title: Effects of Aerobic Training on Cerebrovascular Function, Cognitive Performance and Gait Parameters in Patients With Parkinson's Disease: A Randomized Controlled 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.
Read the detailed description
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
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- Aerobic training, Usual Care
- Keywords
- aerobic training, exercise, rehabilitation, Cerebral blood flow, neurovascular, gait, cardiovascular function, cognition
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic trainingBehavioural
Aerobic Exercise Training
Usual CareBehavioural
Usual Care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Aerobic training |
| Usual Care | Other | Participants will maintain their usual clinical care and daily activities without structured exercise intervention. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cerebrovascular Reactivity
Breath-holding index (dimensionless) assessed by transcranial Doppler
Measured: 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.
Measured: Baseline and 12 weeks
Change in Dynamic Cerebral Autoregulation
Transfer function gain and phase (0.02-0.4 Hz frequency bands).
Measured: Baseline and 12 weeks
Change in Acute Cerebral Blood Flow Response to Exercise
Change in middle cerebral artery velocity during 6-minute aerobic bout.
Measured: Baseline and 12 weeks
Secondary outcomes (30)
Change in Brachial Artery Endothelial Function
Flow-mediated dilation (FMD, %) of the brachial artery assessed by high-resolution vascular ultrasound according to current guidelines.
Measured: Baseline and 12 weeks
Change in Brachial Artery Baseline Diameter
Resting brachial artery diameter (mm) measured by vascular ultrasound
Measured: Baseline and 12 weeks
Change in Carotid Intima-Media Thickness
Common carotid artery intima-media thickness (mm) assessed by B-mode ultrasound.
Measured: Baseline and 12 weeks
Change in Resting Blood Pressure
Systolic and diastolic blood pressure (mmHg).
Measured: Baseline and 12 weeks
Change in Resting Heart Rate
Heart rate (beats per minute).
Measured: Baseline and 12 weeks
Change in SDNN
SDNN derived from beat-to-beat recordings at rest.
Measured: Baseline and 12 weeks
Change in Low Frequency Power
Low-frequency power (ms²) derived from spectral analysis.
Measured: Baseline and 12 weeks
Change in Cognitive Function
Assessed with Montreal Cognitive Assessment that provides a score
Measured: Baseline and 12 weeks
Change in Executive Function and Attention
Assessed with Trail Making Test Part A and Part B (time to completion, seconds).
Measured: 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.
Measured: Baseline and 12 weeks
Change in Parkinson Disease Severity
Assessed with the Unified Parkinson's Disease Rating Scale (UPDRS total score).
Measured: Baseline and 12 weeks
Change in Anxiety Severity
Assessed with the Parkinson Anxiety Scale total score (0-48). Higher scores indicate greater anxiety severity.
Measured: Baseline and 12 weeks
Change in Depressive Symptoms
Assessed with Geriatric Depression Scale total score (0-15). Higher scores indicate greater depressive symptom severity.
Measured: Baseline and 12 weeks
Change in Apathy
Assessed with Apathy Inventory total score (0-12). Higher scores indicate greater apathy.
Measured: Baseline and 12 weeks
Change in Fatigue
Parkinson Fatigue Scale total score (range: 16-80). Higher scores indicate greater fatigue severity.
Measured: 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.
Measured: Baseline and 12 weeks
Change in Pain
Assessed using a Numeric Rating Scale (0-10). Higher values indicate higher pain
Measured: Baseline and 12 weeks
Change in Quality of Life
Assessed with Parkinson's Disease Questionnaire-8 (PDQ-8 total score).
Measured: Baseline and 12 weeks
Change in Gait Speed
Gait speed (meters/second) assessed during overground walking using motion capture analysis.
Measured: Baseline and 12 weeks
Change in Gait Kinematics
Joint angles (degrees) of hip, knee, and ankle during walking assessed by 3D motion capture.
Measured: 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.
Measured: Baseline and 12 weeks
Change in Muscle Thickness
Quadriceps muscle thickness (mm) assessed by B-mode ultrasound at standardized anatomical landmarks.
Measured: Baseline and 12 weeks
Change in Subcutaneous Adipose Tissue Thickness
Subcutaneous fat thickness (mm) assessed by B-mode ultrasound at standardized anatomical landmarks.
Measured: Baseline and 12 weeks
Change in RMMSD
RMSSD (ms) derived from beat-to-beat recordings at rest.
Measured: Baseline and 12 weeks
Change in High Frequency Power
High-frequency power (ms²)derived from spectral analysis
Measured: Baseline and 12 weeks
Change in Low Frequency/High Frequency ratio
Low-frequency/high-frequency ratio derived from spectral analysis
Measured: Baseline and 12 weeks
Change in Cadence
Cadence (steps/minute) assessed during overground walking using motion capture analysis.
Measured: Baseline and 12 weeks
Change in Stride Length
Stride length (meters) assessed during overground walking using motion capture analysis.
Measured: Baseline and 12 weeks
Change in Double Support Time
Double support time (% of gait cycle) assessed during overground walking using motion capture analysis
Measured: 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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start28 Feb 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raphael Mendes Ritti Dias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Raphael Mendes Ritti Dias, University of Nove de Julho
- Investigators
- Raphael M Ritti-Dias, PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478146
- Sponsor's protocol ID
- CardioParkinson
- Acronym
- CardioParkinso
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized datasets will be avaliable after the completion of the study and publication of main results
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Training on Cerebrovascular Function, Cognitive Performance and Gait Parameters in Patients With Parkinson's Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07478146
- Acronym / sponsor ID
- CardioParkinso / CardioParkinson
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- aerobic training, exercise, rehabilitation, Cerebral blood flow, neurovascular, gait, cardiovascular function, cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Raphael Mendes Ritti DiasUniversity, hospital or other
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Training | Experimental | Behavioral: Aerobic trainingParticipants 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 | Behavioral: Usual CareParticipants will maintain their usual clinical care and daily activities without structured exercise intervention. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- Change in medication
- Contraindication to exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic trainingAerobic Exercise Training | Behavioural | Aerobic Training |
| Usual CareUsual Care | Behavioural | Usual Care |
Primary outcome
Change in Cerebrovascular Reactivity
Time frame: Baseline and 12 weeks
Breath-holding index (dimensionless) assessed by transcranial Doppler
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.
Change in Dynamic Cerebral Autoregulation
Time frame: Baseline and 12 weeks
Transfer function gain and phase (0.02-0.4 Hz frequency bands).
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.
30 secondary outcomes
Change in Brachial Artery Endothelial Function
Time frame: Baseline and 12 weeks
Change in Brachial Artery Baseline Diameter
Time frame: Baseline and 12 weeks
Change in Carotid Intima-Media Thickness
Time frame: Baseline and 12 weeks
Change in Resting Blood Pressure
Time frame: Baseline and 12 weeks
Change in Resting Heart Rate
Time frame: Baseline and 12 weeks
Change in SDNN
Time frame: Baseline and 12 weeks
Change in Low Frequency Power
Time frame: Baseline and 12 weeks
Change in Cognitive Function
Time frame: Baseline and 12 weeks
Change in Executive Function and Attention
Time frame: Baseline and 12 weeks
Change in Non-Motor Symptoms
Time frame: Baseline and 12 weeks
Change in Parkinson Disease Severity
Time frame: Baseline and 12 weeks
Change in Anxiety Severity
Time frame: Baseline and 12 weeks
Change in Depressive Symptoms
Time frame: Baseline and 12 weeks
Change in Apathy
Time frame: Baseline and 12 weeks
Change in Fatigue
Time frame: Baseline and 12 weeks
Change in Sleep Quality
Time frame: Baseline and 12 weeks
Change in Pain
Time frame: Baseline and 12 weeks
Change in Quality of Life
Time frame: Baseline and 12 weeks
Change in Gait Speed
Time frame: Baseline and 12 weeks
Change in Gait Kinematics
Time frame: Baseline and 12 weeks
Change in Joint Moments During Walking
Time frame: Baseline and 12 weeks
Change in Muscle Thickness
Time frame: Baseline and 12 weeks
Change in Subcutaneous Adipose Tissue Thickness
Time frame: Baseline and 12 weeks
Change in RMMSD
Time frame: Baseline and 12 weeks
Change in High Frequency Power
Time frame: Baseline and 12 weeks
Change in Low Frequency/High Frequency ratio
Time frame: Baseline and 12 weeks
Change in Cadence
Time frame: Baseline and 12 weeks
Change in Stride Length
Time frame: Baseline and 12 weeks
Change in Double Support Time
Time frame: Baseline and 12 weeks
Change in Joint Powers During Walking
Time frame: Baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. Anonymized datasets will be avaliable after the completion of the study and publication of main results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raphael M Ritti-Dias, PhD principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training in people with PARKINSON DISEASE (Disorder), run by Raphael Mendes Ritti Dias at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raphael M Ritti-Dias, PhD (+5519999406878, raphaelritti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cerebrovascular Reactivity (time frame: Baseline and 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.