search
Back to results

Ocular Hypertension And Yoga Study (OHAYS)

Primary Purpose

Ocular Hypertension, Sleep Disturbance, Stress

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga Intervention
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Hypertension

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18+
  • 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

Exclusion Criteria:

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
  • Sciatica
  • 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

  • Dementia
  • Long or short-term memory loss
  • Unable to read or speak English

Sites / Locations

  • Lions Vision and Research Rehabilitation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yoga

Arm Description

Yoga group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Body Mass Index (BMI) (i.e. weight and height)
Weight and height will be taken at baseline and Post-intervention.
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.
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.
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.
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.
Beck Anxiety Index (BAI)
The 21 item BAI will be used to measure the severity of an individual's anxiety over the past month.
Beck Depression Index (BDI)
We will use the BDI to provide a measure of severity and type of depression.
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.
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.
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.
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).
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.

Full Information

First Posted
September 20, 2011
Last Updated
May 23, 2014
Sponsor
Johns Hopkins University
search

1. Study Identification

Unique Protocol Identification Number
NCT01446588
Brief Title
Ocular Hypertension And Yoga Study
Acronym
OHAYS
Official Title
Ocular Hypertension And Yoga Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Withdrawn
Why Stopped
No Funding was acquired.
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Sleep Disturbance, Stress, Anxiety, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga
Arm Type
Experimental
Arm Description
Yoga group
Intervention Type
Behavioral
Intervention Name(s)
Yoga Intervention
Other Intervention Name(s)
Yoga, Ashtanga
Intervention Description
Three yoga classes per week for 8 weeks.
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP)
Description
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)
Secondary Outcome Measure Information:
Title
Body Mass Index (BMI) (i.e. weight and height)
Description
Weight and height will be taken at baseline and Post-intervention.
Time Frame
Week 0 and week 8
Title
Blood pressure
Description
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
Title
Respiratory Rate (RR)
Description
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
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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
Title
Perceived Stress Scale (PSS)
Description
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
Title
Beck Anxiety Index (BAI)
Description
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
Title
Beck Depression Index (BDI)
Description
We will use the BDI to provide a measure of severity and type of depression.
Time Frame
Week 0 and Week 8
Title
Positive and Negative Affect Schedule (PANAS)
Description
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
Title
Vision Test/Ocular Disease Catastrophizing Scale
Description
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
Title
Philadelphia Mindfulness Scale (PHLMS)
Description
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
Title
Exit Survey
Description
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
Title
Practice Log
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18+ 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 Exclusion Criteria: 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 Sciatica 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 Dementia Long or short-term memory loss Unable to read or speak English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ava Bittner, OD, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lions Vision and Research Rehabilitation
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Ocular Hypertension And Yoga Study

We'll reach out to this number within 24 hrs