High Intensity Endurance Exercise as a Primer to Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in Parkinson's Disease (PD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Balance
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic PD (ages 18 -85) in Hoehn and Yahr stages 2 -
- •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).
排除标准
- •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.
研究组 & 干预措施
High intensity endurance exercise and virtual reality (experimental)
The exercise group will perform high intensity interval exercise and VR-based games 3 times a week for 8 weeks.
干预措施: High intensity endurance exercise (Behavioral)
High intensity endurance exercise and virtual reality (experimental)
The exercise group will perform high intensity interval exercise and VR-based games 3 times a week for 8 weeks.
干预措施: Virtual reality (VR)-based gaming (Behavioral)
Stretching and virtual reality (control)
The stretching group will perform stretching exercises and VR-based games 3 times a week for 8 weeks.
干预措施: Stretching exercise (Behavioral)
Stretching and virtual reality (control)
The stretching group will perform stretching exercises and VR-based games 3 times a week for 8 weeks.
干预措施: Virtual reality (VR)-based gaming (Behavioral)
结局指标
主要结局
Balance
时间窗: 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.
次要结局
- Brain derived neurotrophic growth factor (BDNF)(Baseline, post (8 week), follow-up (14 weeks))
- Corticomotor excitability(Baseline, post (8 week), follow-up (14 weeks))
- Spatiotemporal gait parameters(Baseline, post (8 week), follow-up (14 weeks))
- Spinal reflex excitability(Baseline, post (8 week), follow-up (14 weeks))
- Endurance(Baseline, post (8 week), follow-up (14 weeks))
- Postural stability(Baseline, post (8 week), follow-up (14 weeks))
- Parkinson's Disease Questionnaire (PDQ-39)(Baseline, post (8 week), follow-up (14 weeks))
- Parkinson's Disease Cognitive Rating Scale (PD-CRS)(Baseline, post (8 week), follow-up (14 weeks))
研究者
Anjali Sivaramakrishnan
Assistant Professor
The University of Texas Health Science Center at San Antonio