Ocular Hypertension And Yoga Study (OHAYS)
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.
Behavioral: Yoga Intervention
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Ocular Hypertension And Yoga Study|
- Intraocular Pressure (IOP) [ Time Frame: Change in IOP from mean baseline at 8-weeks (end of yoga intervention period) ] [ Designated as safety issue: Yes ]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.
- Body Mass Index (BMI) (i.e. weight and height) [ Time Frame: Week 0 and week 8 ] [ Designated as safety issue: No ]Weight and height will be taken at baseline and Post-intervention.
- Blood pressure [ Time Frame: once a week for a total period of 11 weeks; then one additional measure 1 month later ] [ Designated as safety issue: No ]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.
- Respiratory Rate (RR) [ Time Frame: Week 0 and Week 8 ] [ Designated as safety issue: No ]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.
- Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Week 0 and Week 8 ] [ Designated as safety issue: No ]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.
- Perceived Stress Scale (PSS) [ Time Frame: Week 0 and Week 8 ] [ Designated as safety issue: No ]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.
- Beck Anxiety Index (BAI) [ Time Frame: Week 0 and Week 8 ] [ Designated as safety issue: No ]The 21 item BAI will be used to measure the severity of an individual's anxiety over the past month.
- Beck Depression Index (BDI) [ Time Frame: Week 0 and Week 8 ] [ Designated as safety issue: No ]We will use the BDI to provide a measure of severity and type of depression.
- Positive and Negative Affect Schedule (PANAS) [ Time Frame: Week 0 and Week 8 ] [ Designated as safety issue: No ]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.
- Vision Test/Ocular Disease Catastrophizing Scale [ Time Frame: Week 0 and Week 8 ] [ Designated as safety issue: No ]The Catastrophizing Scale includes 20 questions that measure the individual's state and/or trait immediately after vision tests are performed.
- Philadelphia Mindfulness Scale (PHLMS) [ Time Frame: Week 0, Week 4 and Week 8 ] [ Designated as safety issue: No ]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.
- Exit Survey [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]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).
- Practice Log [ Time Frame: once a week for a total period of 8 weeks ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||June 2012|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Behavioral: Yoga Intervention
Three yoga classes per week for 8 weeks.
Other Name: Yoga, Ashtanga
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446588
|United States, Maryland|
|Lions Vision and Research Rehabilitation|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Ava Bittner, OD, PhD||Johns Hopkins University|