Clinical trial NCT06133283: Endurance Exercise & Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in PD
Official title: High Intensity Endurance Exercise as a Primer to Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in Parkinson's Disease (PD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Aerobic exercise
Virtual reality
Rehabilitation
Balance
Neurophysiology
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2023-11-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will utilize a randomized controlled design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Balance
timeFrame: Baseline, post (8 week), follow-up (14 weeks)
Secondary outcomes:
measure: Postural stability
timeFrame: Baseline, post (8 week), follow-up (14 weeks)
measure: Endurance
timeFrame: Baseline, post (8 week), follow-up (14 weeks)
measure: Spatiotemporal gait parameters
timeFrame: Baseline, post (8 week), follow-up (14 weeks)
measure: Brain derived neurotrophic growth factor (BDNF)
timeFrame: Baseline, post (8 week), follow-up (14 weeks)
measure: Corticomotor excitability
timeFrame: Baseline, post (8 week), follow-up (14 weeks)
measure: Spinal reflex excitability
timeFrame: Baseline, post (8 week), follow-up (14 weeks)
measure: Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: Baseline, post (8 week), follow-up (14 weeks)
measure: Parkinson's Disease Cognitive Rating Scale (PD-CRS)
timeFrame: Baseline, post (8 week), follow-up (14 weeks)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: UT Health San Antonio- Dept. of Physical Therapy
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Anjali Sivaramakrishnan
role: PRINCIPAL_INVESTIGATOR
References: