Bridging Animal and Human Models of Exercise-induced Visual Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Visual Acuity - Mean Acuity Change
研究概览
简要总结
This study will determine whether blood biomarker changes predict sight-saving benefits of exercise.
详细描述
Investigators of the Atlanta VA Center for Visual and Neurocognitive Rehabilitation (CVNR) find a very high prevalence of blinding diseases in the aging Veteran population. There are few treatments for the disorders that threaten our Veterans' eyesight. The work proposed here is the first step in determining whether exercise can be used by aging Veterans as an inexpensive and self-controlled therapy for vision loss. In order to translate exercise therapy for vision into the clinic, the investigators need to identify biomarkers that can be used to predict visual benefits.
Though human and animal studies show that aerobic exercise is beneficial to specific central and peripheral nervous system functions, effects on the retina and vision were unknown until the investigators recently discovered that treadmill exercise directly protects retinal neurons in mice undergoing light-induced retinal degeneration (LIRD). The investigators found that exercise increased levels of brain-derived neurotrophic factor (BDNF) a blood protein in the blood, brain and eyes, whereas treatment of mice with a BDNF inhibitor prevented the protective effects of exercise.
For this study, the investigators will assess visual outcomes and serum biomarkers (e.g, BDNF) in 60 subjects age 18-89 before, during, and after aerobic exercise. Subjects currently enrolled in a 12-week study (under Institutional Review Board (IRB) 56726) examining the effects of aerobic exercise on cognition will have visual testing (ERG, visual acuity, contrast sensitivity, and OCT) and blood collection prior to, during and after the standardized 12-week aerobic exercise regimen to determine whether circulating biomarker levels and visual outcomes are correlated and whether biomarker levels are altered as predicted in animal studies.
This study will determine whether biomarker changes predict sight-saving benefits of exercise. As opposed to surgery or pharmacological treatments, exercise programs provide a means for Veterans to exert some control over their visual disease progression and will increase their overall health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English speaking
- •Aged 18 to 89
- •Sedentary as defined by < 120 min/week of aerobic exercise over prior 3 months
- •Non-demented (MMSE 24)
排除标准
- •Severe diabetes requiring insulin
- •Cognitive-executive function deficit (MoCA < 26)
结局指标
主要结局
Visual Acuity - Mean Acuity Change
时间窗: 12 weeks
Early Treatment Diabetic Retinopathy Study (ETDRS) chart was used. Higher scores mean a better outcome. The number of correct responses (e.g., number of letters read correctly) from a subject assessed prior to start of the first session of the the 12 week study was subtracted from the number of correct responses elicited at the end of the last session of the study. The means of these differences for each study group (Balance Training vs Aerobic Exercise) were compared by two-tailed t-test.
次要结局
- Contrast Sensitivity(12 weeks)
- Concentration of Brain-Derived Neurotrophic Factor (BDNF) in Serum.(12 weeks)
