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

NCT06133283 | Recruiting

• 2 other identifiers: HSC20230433H1K12TR004529-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson Disease

Keywords

Aerobic exercise; Virtual reality; Rehabilitation; Balance; Neurophysiology

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (8)

• Postural stability

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

• Endurance

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

• Spatiotemporal gait parameters

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

• Brain derived neurotrophic growth factor (BDNF)

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

• Corticomotor excitability

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

Study Arms (2)

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.

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.

Behavioral: Stretching exercise; Behavioral: Virtual reality (VR)-based gaming

Interventions

High intensity endurance exercise BEHAVIORAL

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

High intensity endurance exercise and virtual reality (experimental)

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.

Stretching and virtual reality (control)

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.

High intensity endurance exercise and virtual reality (experimental); Stretching and virtual reality (control)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

UT Health San Antonio- Dept. of Physical Therapy

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anjali Sivaramakrishnan

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anjali Sivaramakrishnan, PhD

CONTACT

210-567-8626; sivaramakris@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will utilize a randomized controlled design

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 15, 2023
• Study Start: February 9, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon publication of the study findings.

Locations

US (1)