Ocular Hypertension And Yoga Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Intraocular Pressure (IOP)
研究概览
简要总结
The investigators aim to pilot test the efficacy of a yoga intervention designed specifically for individuals with ocular hypertension. The investigators would like to find out if a combination of breathing, postures and meditation may help to reduce intraocular pressure in the short term after each yoga session, and also long-term across an 8-week program. Subjects will participate in the yoga intervention sessions led by Dr. Pamela Jeter once a week at the investigators center, and will be asked to practice at home at least twice a week using a audio CD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of ocular hypertension not requiring treatment of IOP
- •IOP in at least one eye ≥ 21 mm Hg
- •Normal Humphrey 24-2 or 30-2 visual fields for both eyes as determined by the patient's glaucoma specialist
- •Best-corrected visual acuity better than 20/40 in both eyes
- •Being healthy to the extent that participation in yoga therapy would not exacerbate any existing disease conditions;
- •Participants do not engage in athletic activity on a regular basis (i.e. are sedentary)
- •Able and willing to participate on a weekly basis for the 11-week intervention;
- •Informed consent
排除标准
- •VISUAL HISTORY
- •Any visual field loss in either eye consistently detected with Humphrey Visual Field 30-2 or 24-2
- •Inability to understand study procedures or communicate responses to visual stimuli in a consistent manner (cognitive impairment)
- •Previous intraocular surgery, except for uncomplicated extracapsular cataract extraction with posterior chamber-intraocular lens implant and no escape of vitreous to the anterior chamber, strabismus, cosmetic eyelid surgery, and radial keratotomy
- •Secondary causes of elevated IOP, including ocular and systemic corticosteroid use
- •Angle closure glaucoma or anatomically narrow angles-75% of the circumference of the angle must be grade 2 or more by Shaffer criteria
- •Pigmentary glaucoma
- •Congenital glaucoma
- •Other diseases that cause visual field loss or optic disc abnormalities
- •Difference in cup-disc ratios (horizontal by contour) between the two eyes of >0.2
- •Background diabetic retinopathy, defined as at least 1 microaneurysm seen on ophthalmoscopy with dilated pupil, or any retinal hemorrhage
- •SPECIFIC SYSTEMIC DISEASES/CONDITIONS
- •Abdominal Aneurism
- •Cancer, metastatic
- •Fibromyalgia, severe
- •Inflammatory autoimmune diseases (e.g. Lupus, Rheumatoid arthritis, Scleroderma)
- •Other disabling chronic conditions (e.g., disabling heart or lung disease, diabetic neuropathy, receiving treatment for hepatitis)
- •A life-threatening or debilitating disease
- •BACK PROBLEM OF COMPLICATED NATURE, INCLUDING MEDICO-LEGAL ISSUES
- •Seeking/receiving compensation/litigation for back pain
- •Previous back surgery, ever
- •Low back pain that has lasted > 1 month
- •Severe pain when bending or twisting spine
- •Discitis or Disk disease
- •Fracture of vertebra
- •Infectious cause of back pain
- •Scoliosis, severe or progressive
- •Spinal stenosis
- •Spondylolisthesis
- •Anklyosing spondylitis
- •CONDITIONS THAT MIGHT MAKE IT DIFFICULT TO ATTEND THE CLASSES OR PRACTICE AT HOME.
- •Deafness or severe hearing problems
- •Psychoses, major
- •Schedules do not permit participation in classes or home practice (including planning to move out of town)
- •Paralysis
- •Unable to walk two city blocks
- •Unable to get up and down from floor
- •Lack of transportation
- •Any planned surgery during the upcoming study period
- •CONDITIONS/CIRCUMSTANCES THAT MIGHT CONFOUND TREATMENT EFFECTS OR INTERPRETATION OF DATA
- •Pregnant or nursing women as determined by patient self-report
- •Use of psychotropic medication
- •Consumption of more than three alcoholic beverages per day
- •Smoking more than 10 cigarettes per day
- •Recent substance abuse
- •CONDITION WOULD MAKE IT DIFFICULT TO PROVIDE FULLY INFORMED CONSENT
- •Long or short-term memory loss
- •Unable to read or speak English
结局指标
主要结局
Intraocular Pressure (IOP)
时间窗: Change in IOP from mean baseline at 8-weeks (end of yoga intervention period)
Baseline IOP measures will be obtained at two visits prior to the intervention. At each weekly visit, we will obtain two series of IOP measures about one hour apart, similar to the sequence that will be used during the weekly yoga intervention, to estimate trends over an 8-week intervention period. Post-intervention IOP will be measured at a single session one week after the yoga intervention has ended, and at a follow-up visit one month after the yoga intervention. Subjects will be masked to the IOP results until they have completed the study.
次要结局
- Beck Anxiety Index (BAI)(Week 0 and Week 8)
- Body Mass Index (BMI) (i.e. weight and height)(Week 0 and week 8)
- Blood pressure(once a week for a total period of 11 weeks; then one additional measure 1 month later)
- Beck Depression Index (BDI)(Week 0 and Week 8)
- Positive and Negative Affect Schedule (PANAS)(Week 0 and Week 8)
- Vision Test/Ocular Disease Catastrophizing Scale(Week 0 and Week 8)
- Philadelphia Mindfulness Scale (PHLMS)(Week 0, Week 4 and Week 8)
- Exit Survey(Week 8)
- Practice Log(once a week for a total period of 8 weeks)
- Respiratory Rate (RR)(Week 0 and Week 8)
- Pittsburgh Sleep Quality Index (PSQI)(Week 0 and Week 8)
- Perceived Stress Scale (PSS)(Week 0 and Week 8)
研究者
Pamela Jeter
Postdoctoral Research Fellow
Johns Hopkins University