Ocular Hypertension And Yoga Study (OHAYS)
|ClinicalTrials.gov Identifier: NCT01446588|
Recruitment Status : Withdrawn (No Funding was acquired.)
First Posted : October 5, 2011
Last Update Posted : May 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Ocular Hypertension Sleep Disturbance Stress Anxiety Depression||Behavioral: Yoga Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ocular Hypertension And Yoga Study|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Behavioral: Yoga Intervention
Three yoga classes per week for 8 weeks.
Other Name: Yoga, Ashtanga
- Intraocular Pressure (IOP) [ Time Frame: 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.
- Body Mass Index (BMI) (i.e. weight and height) [ Time Frame: Week 0 and week 8 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446588
|United States, Maryland|
|Lions Vision and Research Rehabilitation|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Ava Bittner, OD, PhD||Johns Hopkins University|