Parkinson Disease
Conditions
Keywords
Aerobic exercise, Virtual reality, Rehabilitation, Balance, Neurophysiology
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.
Interventions
BEHAVIORALHigh intensity endurance exercise
High intensity interval exercise on a recumbent stepper for 30 minutes, 3 days per week.
BEHAVIORALStretching exercise
Stretches of face, neck, upper extremity, trunk and lower extremity muscles including whole body stretches for 30 minutes, 3 days per week.
BEHAVIORALVirtual 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.
Sponsors
The University of Texas Health Science Center at San Antonio
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study will utilize a randomized controlled design
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Balance | Baseline, post (8 week), follow-up (14 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postural stability | Baseline, post (8 week), follow-up (14 weeks) | Postural stability will be assessed by the Biodex Balance System. |
| Endurance | Baseline, post (8 week), follow-up (14 weeks) | The 6-minute walk test will be used as a measure of cardiovascular endurance |
| Spatiotemporal gait parameters | Baseline, post (8 week), follow-up (14 weeks) | Spatiotemporal measures of gait will be acquired with the GAITRite™ gait mat. |
| Brain derived neurotrophic growth factor (BDNF) | Baseline, post (8 week), follow-up (14 weeks) | Blood sample will be obtained for measuring circulating levels of brain derived neurotrophic growth factor (BDNF). |
| Corticomotor excitability | Baseline, post (8 week), follow-up (14 weeks) | Corticomotor excitability for the tibialis anterior motor representations will be measured with single and paired pulse transcranial magnetic stimulation (TMS). |
| Spinal reflex excitability | Baseline, post (8 week), follow-up (14 weeks) | 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). |
| Parkinson's Disease Questionnaire (PDQ-39) | Baseline, post (8 week), follow-up (14 weeks) | 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. |
| Parkinson's Disease Cognitive Rating Scale (PD-CRS) | Baseline, post (8 week), follow-up (14 weeks) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnjali Sivaramakrishnan
The University of Texas Health Science Center at San Antonio
Outcome results
None listed