An interventional study of Yoga Intervention in Ocular Hypertension, Sleep Disturbance and Stress, sponsored by Johns Hopkins University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-26.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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Exclusion Criteria:
VISUAL HISTORY
SPECIFIC SYSTEMIC DISEASES/CONDITIONS
BACK PROBLEM OF COMPLICATED NATURE, INCLUDING MEDICO-LEGAL ISSUES
CONDITIONS THAT MIGHT MAKE IT DIFFICULT TO ATTEND THE CLASSES OR PRACTICE AT HOME.
CONDITIONS/CIRCUMSTANCES THAT MIGHT CONFOUND TREATMENT EFFECTS OR INTERPRETATION OF DATA
CONDITION WOULD MAKE IT DIFFICULT TO PROVIDE FULLY INFORMED CONSENT
Yoga group
Behavioral: Yoga Intervention
Three yoga classes per week for 8 weeks.
Also known as: Yoga, Ashtanga
Intraocular Pressure (IOP)
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.
Time frame: Change in IOP from mean baseline at 8-weeks (end of yoga intervention period)
Body Mass Index (BMI) (i.e. weight and height)
Weight and height will be taken at baseline and Post-intervention.
Time frame: Week 0 and week 8
Blood pressure
Systemic blood pressure (using a digital monitor with an automated cuff) and pulse rate will be measured at baseline, at the beginning and end of each yoga class, and the two post-intervention visits.
Time frame: once a week for a total period of 11 weeks; then one additional measure 1 month later
Respiratory Rate (RR)
Respiratory rate will be measured twice for each participant to reduce within-session variability. It will be determined by counting the number of inhalations with a stethoscope for 30 seconds at rest and multiplying by two at baseline and post-intervention.
Time frame: Week 0 and Week 8
Pittsburgh Sleep Quality Index (PSQI)
The 19-item PSQI questionnaire will be used to gauge sleep quality over the past month. It includes both qualitative and quantitative aspects of sleep, and evaluates seven subscale dimensions of sleep quality. Measured at baseline (week 0) and immediately after the 8-week intervention.
Time frame: Week 0 and Week 8
Perceived Stress Scale (PSS)
In order to subjectively assess the degree to which respondents have appraised situations in their life to be stressful on a given day, we will administer the 14 item PSS.
Time frame: Week 0 and Week 8
Beck Anxiety Index (BAI)
The 21 item BAI will be used to measure the severity of an individual's anxiety over the past month.
Time frame: Week 0 and Week 8
Beck Depression Index (BDI)
We will use the BDI to provide a measure of severity and type of depression.
Time frame: Week 0 and Week 8
Positive and Negative Affect Schedule (PANAS)
The PANAS questionnaire consists of 10 positive affect items, which reflect one's level of pleasurable engagement with the environment, and 10 negative affect items, which are a general factor of subjective distress.
Time frame: Week 0 and Week 8
Vision Test/Ocular Disease Catastrophizing Scale
The Catastrophizing Scale includes 20 questions that measure the individual's state and/or trait immediately after vision tests are performed.
Time frame: Week 0 and Week 8
Philadelphia Mindfulness Scale (PHLMS)
This 20-item scale assesses two components of mindfulness, acceptance and awareness. Total scores on both subscales range from 20 to 100, higher scores reflect greater mindfulness. The PHLMS will be collected at baseline, during week 4 and post- intervention.
Time frame: Week 0, Week 4 and Week 8
Exit Survey
Participants will complete a brief survey regarding their experience with the yoga class. The survey is comprised of open-ended and multiple-choice response items (e.g. treatment expectations).
Time frame: Week 8
Practice Log
Participants will be asked to complete a weekly log online to report the activity performed, time allotted to the practice and will be used to evaluate compliance.
Time frame: once a week for a total period of 8 weeks
This study is withdrawn, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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