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NCT Number: NCT06133283

Endurance Exercise & Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in 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).

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Health San Antonio- Dept. of Physical Therapy

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

High Intensity Endurance Exercise

Behavioral

High intensity interval exercise on a recumbent stepper for 30 minutes, 3 days per week.

Stretching exercise

Behavioral

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 gaming

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postural stability

    Time frame: Baseline, post (8 week), follow-up (14 weeks)

    Postural stability will be assessed by the Biodex Balance System.

  2. Endurance

    Time frame: Baseline, post (8 week), follow-up (14 weeks)

    The 6-minute walk test will be used as a measure of cardiovascular endurance

  3. Spatiotemporal gait parameters

    Time frame: Baseline, post (8 week), follow-up (14 weeks)

    Spatiotemporal measures of gait will be acquired with the GAITRite™ gait mat.

  4. Brain derived neurotrophic growth factor (BDNF)

    Time frame: Baseline, post (8 week), follow-up (14 weeks)

    Blood sample will be obtained for measuring circulating levels of brain derived neurotrophic growth factor (BDNF).

  5. Corticomotor excitability

    Time frame: Baseline, post (8 week), follow-up (14 weeks)

    Corticomotor excitability for the tibialis anterior motor representations will be measured with single and paired pulse transcranial magnetic stimulation (TMS).

  6. Spinal reflex excitability

    Time frame: Baseline, post (8 week), follow-up (14 weeks)

    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).

  7. Parkinson's Disease Questionnaire (PDQ-39)

    Time frame: Baseline, post (8 week), follow-up (14 weeks)

    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.

  8. Parkinson's Disease Cognitive Rating Scale (PD-CRS)

    Time frame: Baseline, post (8 week), follow-up (14 weeks)

    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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

High Intensity Endurance Exercise as a Primer to Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in Parkinson's Disease (PD)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 15, 2023
Registry last updated
Jul 30, 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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