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| ID | Type | Description | Link |
|---|---|---|---|
| 1K12TR004529-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Stretching and virtual reality (control) | Other | The stretching group will perform stretching exercises and VR-based games 3 times a week for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High intensity endurance exercise | Behavioral | High intensity interval exercise on a recumbent stepper for 30 minutes, 3 days per week. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Postural stability | Postural stability will be assessed by the Biodex Balance System. | Baseline, post (8 week), follow-up (14 weeks) |
| Endurance | The 6-minute walk test will be used as a measure of cardiovascular endurance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anjali Sivaramakrishnan, PhD | Contact | 210-567-8626 | sivaramakris@uthscsa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anjali Sivaramakrishnan | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Health San Antonio- Dept. of Physical Therapy | Recruiting | San Antonio | Texas | 78229 | United States |
All collected deidentified individual participant data (IPD) will be shared on an open source platform and summary results will be shared on ClinicalTrials.gov.
Upon publication of the study findings.
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This study will utilize a randomized controlled design
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| 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. |
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| 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. |
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| Baseline, post (8 week), follow-up (14 weeks) |
| Spatiotemporal gait parameters | Spatiotemporal measures of gait will be acquired with the GAITRiteā¢ gait mat. | Baseline, post (8 week), follow-up (14 weeks) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D052580 | Muscle Stretching Exercises |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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