Endurance Exercise & Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in PD
- Conditions
- Parkinson Disease
- Interventions
- Behavioral: High intensity endurance exerciseBehavioral: Stretching exerciseBehavioral: Virtual reality (VR)-based gaming
- Registration Number
- NCT06133283
- Brief 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). 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 16
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High intensity endurance exercise and virtual reality (experimental) High intensity endurance exercise The exercise group will perform high intensity interval exercise and VR-based games 3 times a week for 8 weeks. Stretching and virtual reality (control) Stretching exercise The stretching group will perform stretching exercises and VR-based games 3 times a week for 8 weeks. High intensity endurance exercise and virtual reality (experimental) Virtual reality (VR)-based gaming The exercise group will perform high intensity interval exercise and VR-based games 3 times a week for 8 weeks. Stretching and virtual reality (control) Virtual reality (VR)-based gaming The stretching group will perform stretching exercises and VR-based games 3 times a week for 8 weeks.
- Primary Outcome Measures
Name Time Method Balance 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 Outcome Measures
Name Time Method Brain derived neurotrophic growth factor (BDNF) Baseline, post (8 week), follow-up (14 weeks) Blood sample will be obtained for measuring circulating levels of brain derived neurotrophic growth factor (BDNF).
Corticomotor excitability 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).
Spatiotemporal gait parameters Baseline, post (8 week), follow-up (14 weeks) Spatiotemporal measures of gait will be acquired with the GAITRite™ gait mat.
Spinal reflex excitability 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).
Endurance Baseline, post (8 week), follow-up (14 weeks) The 6-minute walk test will be used as a measure of cardiovascular endurance
Postural stability Baseline, post (8 week), follow-up (14 weeks) Postural stability will be assessed by the Biodex Balance System.
Parkinson's Disease Questionnaire (PDQ-39) 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.
Parkinson's Disease Cognitive Rating Scale (PD-CRS) 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.
Trial Locations
- Locations (1)
UT Health San Antonio- Dept. of Physical Therapy
🇺🇸San Antonio, Texas, United States