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

The University of Texas System (UT)

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Behavioral: Stretching exercise; Behavioral: High intensity endurance exercise; Behavioral: Virtual reality (VR)-based gaming

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06133283

1K12TR004529-01 (U.S. NIH Grant/Contract)

HSC20230433H

Details and patient eligibility

About

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).

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of idiopathic PD (ages 18 -85) in Hoehn and Yahr stages 2 - 3.
2. Subjects need to demonstrate a score of equal to or greater than 23 on the Mini Mental State Examination.
3. Subjects who have a score of ≤21.5 on the Mini Balance Evaluations Systems Test (miniBESTest).

Exclusion criteria

1. Subjects with a history of other neurological diseases (i.e., stroke, multiple sclerosis).
2. Subjects with a history of severe cardiopulmonary disease, uncontrolled hypertension, orthostatic hypotension, uncontrolled diabetes, severe osteoporosis, severe arthritis affecting their lower extremity joints.
3. Subjects with a history of PD-specific surgical procedures such as deep brain stimulation etc.
4. Subjects with a history of head injury.
5. Subjects with a history of seizures or epilepsy.
6. Subjects who are currently pregnant.
7. Individuals who use of medications that could alter corticomotor excitability or increase risk of seizure.
8. Individuals with skull abnormalities, fractures or unexplained, recurring headaches.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

16 participants in 2 patient groups

High intensity endurance exercise and virtual reality (experimental)

Experimental group

Description:

The exercise group will perform high intensity interval exercise and VR-based games 3 times a week for 8 weeks.

Treatment:

Behavioral: Virtual reality (VR)-based gaming

Behavioral: High intensity endurance exercise

Stretching and virtual reality (control)

Other group

Description:

The stretching group will perform stretching exercises and VR-based games 3 times a week for 8 weeks.

Treatment:

Behavioral: Virtual reality (VR)-based gaming

Behavioral: Stretching exercise