Parkinson DiseaseNCT06133283
Endurance Exercise & Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in PD
A study testing High intensity endurance exercise, Stretching exercise and Virtual reality (VR)-based gaming in people with Parkinson Disease, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
This study aims to determine the effects of aerobic exercise as a primer to add-on virtual reality (VR)-based rehabilitation on balance, postural control and neuroplasticity (ability of brain to adapt in structure and function) in individuals with Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- High intensity endurance exercise, Stretching exercise and Virtual reality (VR)-based gaming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2024to 11 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic PD (ages 18 -85) in Hoehn and Yahr stages 2 - 3.
- Subjects need to demonstrate a score of equal to or greater than 23 on the Mini Mental State Examination.
- Subjects who have a score of ≤21.5 on the Mini Balance Evaluations Systems Test (miniBESTest).
Who cannot join
- Subjects with a history of other neurological diseases (i.e., stroke, multiple sclerosis).
- Subjects with a history of severe cardiopulmonary disease, uncontrolled hypertension, orthostatic hypotension, uncontrolled diabetes, severe osteoporosis, severe arthritis affecting their lower extremity joints.
- Subjects with a history of PD-specific surgical procedures such as deep brain stimulation etc.
- Subjects with a history of head injury.
- Subjects with a history of seizures or epilepsy.
- Subjects who are currently pregnant.
- Individuals who use of medications that could alter corticomotor excitability or increase risk of seizure.
- Individuals with skull abnormalities, fractures or unexplained, recurring headaches.
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Health San Antonio- Dept. of Physical Therapy
San Antonio, Texas, 78229
About this study
Official title: High Intensity Endurance Exercise as a Primer to Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in Parkinson's Disease (PD)
This study aims to determine the effects of aerobic exercise as a primer to add-on virtual reality (VR)-based rehabilitation on balance, postural control and neuroplasticity (ability of brain to adapt in structure and function) in individuals with Parkinson's disease (PD). This study will utilize two groups - one group will receive the exercise and VR, while the other group will receive stretching exercise and VR over eight weeks. The study team will administer outcomes at baseline, post-intervention (8 weeks) and follow-up (6 weeks after post-assessment).
Read the detailed description
This study will enroll individuals diagnosed with Parkinson's disease who will be randomly assigned to 2 groups: 1) high intensity endurance exercise and virtual reality (experimental) or 2) stretching and virtual reality (control) for eight weeks (three sessions, thrice weekly). Outcomes will include balance and gait measures, blood-based biomarkers, neuroplasticity measures (assessed by transcranial magnetic stimulation), spinal reflex excitability (measured by H reflex) and quality of life.
- Conditions
- Parkinson Disease
- Being tested
- High intensity endurance exercise, Stretching exercise, Virtual reality (VR)-based gaming
- Keywords
- Aerobic exercise, Virtual reality, Rehabilitation, Balance, Neurophysiology
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity endurance exerciseBehavioural
High intensity interval exercise on a recumbent stepper for 30 minutes, 3 days per week.
Stretching exerciseBehavioural
Stretches of face, neck, upper extremity, trunk and lower extremity muscles including whole body stretches for 30 minutes, 3 days per week.
Virtual reality (VR)-based gamingBehavioural
VR games will involve games that challenge balance such as reaching different targets during activities such as sit to stand, dodging obstacles etc. Participants will play approximately 6 games for 30 minutes, 3 days a week.
| Study group | Role | What they receive |
|---|---|---|
| High intensity endurance exercise and virtual reality (experimental) | Experimental | The exercise group will perform high intensity interval exercise and VR-based games 3 times a week for 8 weeks. Receives: Behavioral: High intensity endurance exercise; Behavioral: Virtual reality (VR)-based gaming |
| Stretching and virtual reality (control) | Other | The stretching group will perform stretching exercises and VR-based games 3 times a week for 8 weeks. Receives: Behavioral: Stretching exercise; Behavioral: Virtual reality (VR)-based gaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Balance will be tested with the Mini Balance Evaluation Systems Test(miniBESTest), involving 14 different tasks including the timed up and go test to assess static and dynamic balance. Scores range from 0 to 28 with higher scores suggesting better balance.
Measured: Baseline, post (8 week), follow-up (14 weeks)
Secondary outcomes (8)
Postural stability
Postural stability will be assessed by the Biodex Balance System.
Measured: Baseline, post (8 week), follow-up (14 weeks)
Endurance
The 6-minute walk test will be used as a measure of cardiovascular endurance
Measured: Baseline, post (8 week), follow-up (14 weeks)
Spatiotemporal gait parameters
Spatiotemporal measures of gait will be acquired with the GAITRite™ gait mat.
Measured: Baseline, post (8 week), follow-up (14 weeks)
Brain derived neurotrophic growth factor (BDNF)
Blood sample will be obtained for measuring circulating levels of brain derived neurotrophic growth factor (BDNF).
Measured: Baseline, post (8 week), follow-up (14 weeks)
Corticomotor excitability
Corticomotor excitability for the tibialis anterior motor representations will be measured with single and paired pulse transcranial magnetic stimulation (TMS).
Measured: Baseline, post (8 week), follow-up (14 weeks)
Spinal reflex excitability
H reflexes will be recorded for quantifying spinal reflex excitability. The H wave amplitude will be expressed as a % of the M wave amplitude (H/M ratio).
Measured: Baseline, post (8 week), follow-up (14 weeks)
Parkinson's Disease Questionnaire (PDQ-39)
The Parkinson's disease questionnaire (PDQ-39) is a self report questionnaire that will be used to evaluate quality of life. The questionnaire consists of 39 items with each item being rated on a 5-point scale. Lower scores suggest higher quality of life.
Measured: Baseline, post (8 week), follow-up (14 weeks)
Parkinson's Disease Cognitive Rating Scale (PD-CRS)
The Parkinson's disease cognitive rating scale will be used to test frontal subcortical tasks such as attention, working memory, verbal fluency and posterior cortical tasks such as confrontation naming and copying a clock. Scores range from 0 - 134 and higher scores suggest better cognitive function.
Measured: Baseline, post (8 week), follow-up (14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start9 Feb 2024
- Primary completion11 Nov 2025
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Model description
- This study will utilize a randomized controlled design
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Anjali Sivaramakrishnan, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133283
- Sponsor's protocol ID
- HSC20230433H
- Other IDs
- 1K12TR004529-01
- Status last verified
- Jul 2026
- First submitted
- 7 Nov 2023
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected deidentified individual participant data (IPD) will be shared on an open source platform and summary results will be shared on ClinicalTrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Endurance Exercise as a Primer to Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in Parkinson's Disease (PD)
- ClinicalTrials.gov ID
- NCT06133283
- Acronym / sponsor ID
- HSC20230433H
- Conditions
- Parkinson Disease
- Keywords
- Aerobic exercise, Virtual reality, Rehabilitation, Balance, Neurophysiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 15 Nov 2023 (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 study aims to determine the effects of aerobic exercise as a primer to add-on virtual reality (VR)-based rehabilitation on balance, postural control and neuroplasticity (ability of brain to adapt in structure and function) in individuals with Parkinson's disease (PD). This study will utilize two groups - one group will receive the exercise and VR, while the other group will receive stretching exercise and VR over eight weeks. The study team will administer outcomes at baseline, post-intervention (8 weeks) and follow-up (6 weeks after post-assessment).
Detailed description
This study will enroll individuals diagnosed with Parkinson's disease who will be randomly assigned to 2 groups: 1) high intensity endurance exercise and virtual reality (experimental) or 2) stretching and virtual reality (control) for eight weeks (three sessions, thrice weekly). Outcomes will include balance and gait measures, blood-based biomarkers, neuroplasticity measures (assessed by transcranial magnetic stimulation), spinal reflex excitability (measured by H reflex) and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will utilize a randomized controlled design
| Arm | Type | Receives |
|---|---|---|
| High intensity endurance exercise and virtual reality (experimental) | Experimental | Behavioral: High intensity endurance exercise, Behavioral: Virtual reality (VR)-based gamingThe exercise group will perform high intensity interval exercise and VR-based games 3 times a week for 8 weeks. |
| Stretching and virtual reality (control) | Other | Behavioral: Stretching exercise, Behavioral: Virtual reality (VR)-based gamingThe stretching group will perform stretching exercises and VR-based games 3 times a week for 8 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of idiopathic PD (ages 18 -85) in Hoehn and Yahr stages 2 - 3.
- Subjects need to demonstrate a score of equal to or greater than 23 on the Mini Mental State Examination.
- Subjects who have a score of ≤21.5 on the Mini Balance Evaluations Systems Test (miniBESTest).
Key exclusion criteria (8 listed)
- Subjects with a history of other neurological diseases (i.e., stroke, multiple sclerosis).
- Subjects with a history of severe cardiopulmonary disease, uncontrolled hypertension, orthostatic hypotension, uncontrolled diabetes, severe osteoporosis, severe arthritis affecting their lower extremity joints.
- Subjects with a history of PD-specific surgical procedures such as deep brain stimulation etc.
- Subjects with a history of head injury.
- Subjects with a history of seizures or epilepsy.
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 |
|---|---|---|
| High intensity endurance exerciseHigh intensity interval exercise on a recumbent stepper for 30 minutes, 3 days per week. | Behavioural | High intensity endurance exercise and virtual reality (experimental) |
| Stretching exerciseStretches of face, neck, upper extremity, trunk and lower extremity muscles including whole body stretches for 30 minutes, 3 days per week. | Behavioural | Stretching and virtual reality (control) |
| Virtual reality (VR)-based gamingVR games will involve games that challenge balance such as reaching different targets during activities such as sit to stand, dodging obstacles etc. Participants will play approximately 6 games for 30 minutes, 3 days a week. | Behavioural | High intensity endurance exercise and virtual reality (experimental), Stretching and virtual reality (control) |
Primary outcome
Balance
Time frame: Baseline, post (8 week), follow-up (14 weeks)
Balance will be tested with the Mini Balance Evaluation Systems Test(miniBESTest), involving 14 different tasks including the timed up and go test to assess static and dynamic balance. Scores range from 0 to 28 with higher scores suggesting better balance.
8 secondary outcomes
Postural stability
Time frame: Baseline, post (8 week), follow-up (14 weeks)
Endurance
Time frame: Baseline, post (8 week), follow-up (14 weeks)
Spatiotemporal gait parameters
Time frame: Baseline, post (8 week), follow-up (14 weeks)
Brain derived neurotrophic growth factor (BDNF)
Time frame: Baseline, post (8 week), follow-up (14 weeks)
Corticomotor excitability
Time frame: Baseline, post (8 week), follow-up (14 weeks)
Spinal reflex excitability
Time frame: Baseline, post (8 week), follow-up (14 weeks)
Parkinson's Disease Questionnaire (PDQ-39)
Time frame: Baseline, post (8 week), follow-up (14 weeks)
Parkinson's Disease Cognitive Rating Scale (PD-CRS)
Time frame: Baseline, post (8 week), follow-up (14 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Yes. All collected deidentified individual participant data (IPD) will be shared on an open source platform and summary results will be shared on ClinicalTrials.gov.
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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. This study is not recruiting at the moment.
Anjali Sivaramakrishnan principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity endurance exercise, Stretching exercise and Virtual reality (VR)-based gaming in people with Parkinson Disease, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 30 Jul 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: Baseline, post (8 week), follow-up (14 weeks)). 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 30 Jul 2026.