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

NCT ID: NCT06133283

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-09

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will utilize a randomized controlled design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High intensity endurance exercise and virtual reality (experimental)

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

Group Type EXPERIMENTAL

High intensity endurance exercise

Intervention Type BEHAVIORAL

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

Virtual reality (VR)-based gaming

Intervention Type 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.

Stretching and virtual reality (control)

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

Group Type OTHER

Stretching exercise

Intervention Type 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

Intervention Type 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.

Interventions

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High intensity endurance exercise

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

Intervention Type BEHAVIORAL

Stretching exercise

Stretches of face, neck, upper extremity, trunk and lower extremity muscles including whole body stretches for 30 minutes, 3 days per week.

Intervention Type BEHAVIORAL

Virtual reality (VR)-based gaming

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Anjali Sivaramakrishnan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anjali Sivaramakrishnan

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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UT Health San Antonio- Dept. of Physical Therapy

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anjali Sivaramakrishnan, PhD

Role: CONTACT

210-567-8626

Facility Contacts

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Anjali Sivaramakrishnan, PT, PhD

Role: primary

210-567-8626

Other Identifiers

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1K12TR004529-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC20230433H

Identifier Type: -

Identifier Source: org_study_id

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