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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06133283
• Other study ID #: HSC20230433H
• Secondary ID: 1K12TR004529-01
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2024
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Anjali Sivaramakrishnan, PhD
• Phone: 210-567-8626
• Email: sivaramakris[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• High intensity endurance exercise
High intensity interval exercise on a recumbent stepper for 30 minutes, 3 days per week.
• Stretching exercise
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
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.

Locations

Country	Name	City	State
United States	UT Health San Antonio- Dept. of Physical Therapy	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postural stability	Postural stability will be assessed by the Biodex Balance System.	Baseline, post (8 week), follow-up (14 weeks)
Secondary	Endurance	The 6-minute walk test will be used as a measure of cardiovascular endurance	Baseline, post (8 week), follow-up (14 weeks)
Secondary	Spatiotemporal gait parameters	Spatiotemporal measures of gait will be acquired with the GAITRite™ gait mat.	Baseline, post (8 week), follow-up (14 weeks)
Secondary	Brain derived neurotrophic growth factor (BDNF)	Blood sample will be obtained for measuring circulating levels of brain derived neurotrophic growth factor (BDNF).	Baseline, post (8 week), follow-up (14 weeks)
Secondary	Corticomotor excitability	Corticomotor excitability for the tibialis anterior motor representations will be measured with single and paired pulse transcranial magnetic stimulation (TMS).	Baseline, post (8 week), follow-up (14 weeks)
Secondary	Spinal reflex excitability	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).	Baseline, post (8 week), follow-up (14 weeks)
Secondary	Parkinson's Disease Questionnaire (PDQ-39)	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.	Baseline, post (8 week), follow-up (14 weeks)
Secondary	Parkinson's Disease Cognitive Rating Scale (PD-CRS)	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.	Baseline, post (8 week), follow-up (14 weeks)