Back to resultsYoga for Persons With Severe Visual Impairment (RPY)
Primary Purpose
Sleep Disturbance, Stress, Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Disturbance
Eligibility Criteria
Inclusion Criteria:
- Age 18+
- Legal blindness (visual acuity worse than 20/200 but better than no/bare light perception, and/or visual field less than 20º, in the better eye)
- Any ocular disease diagnosis that is expected to remain relatively stable throughout a 3-6 month period
- Being healthy to the extent that participation yoga therapy would not exacerbate any existing disease conditions;
- Willingness to participate on a weekly basis for the 12-week intervention;
- Moderate to severe sleep disturbances, defined as ratings of 5 or greater on the PSQI
Exclusion Criteria:
- Significant changes to vision within the most recent 3-month period
- Inability to understand study procedures or communicate responses to visual stimuli in a consistent manner
- Clinically diagnosed or clinically significant sleep disorder (e.g., sleep apnea) or a medical or psychiatric condition (e.g., chronic pain) responsible for sleep complaints;
- Use of prescription sleep medication more than once a week for duration of the study;
- Use of other psychotropic medication;
- Current recipient of sleep disorder treatment;
- Consumption of more than 2-3 alcoholic beverages per day
- Smoking more than 10 cigarettes per day;
Sites / Locations
- Lions Vision and Research Rehabilitation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Yoga Therapy
Arm Description
Outcomes
Primary Outcome Measures
Static Balance
Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
Secondary Outcome Measures
Perceived Stress Scale
Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
Profile of Mood States - Short Form
Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
Exit Survey
The exist survey is administered immediately after the intervention during Week 8.
Fear of Falling Questionnaire
Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01366677
Brief Title
Yoga for Persons With Severe Visual Impairment
Acronym
RPY
Official Title
Development of a Yoga Intervention for Symptoms Related to Severe Visual Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (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
This study aims to provide novel information on the feasibility of yoga interventions for secondary symptoms related to severe vision loss, such as sleep disturbances, negative mood states, fall risk and balance. This information will be important for determining safe, cost-effective and reliable practices for the benefits of yoga as an alternative means for improved health and well-being. A yoga intervention that is integrative and evidence-based will benefit the blind population through effective treatments and prevention of secondary symptoms as well as serve to inform rehabilitation specialists, educators, and clinicians in the future.
Detailed Description
This study aims to provide novel information on the feasibility of yoga interventions for secondary symptoms related to severe vision loss, such as sleep disturbances, negative mood states, fall risk and balance. This information will be important for determining safe, cost-effective and reliable practices for the benefits of yoga as an alternative means for improved health and well-being. A yoga intervention that is integrative and evidence-based will benefit the blind population through effective treatments and prevention of secondary symptoms as well as serve to inform rehabilitation specialists, educators, and clinicians in the future.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance, Stress, Anxiety, Depression, Balance Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga Therapy
Arm Type
Experimental
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
Static Balance
Description
Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
Time Frame
Week 0 and Week 8.
Secondary Outcome Measure Information:
Title
Perceived Stress Scale
Description
Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
Time Frame
Week 0 and Week 8
Title
Profile of Mood States - Short Form
Description
Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
Time Frame
Week 0 and Week 8
Title
Exit Survey
Description
The exist survey is administered immediately after the intervention during Week 8.
Time Frame
Week 8
Title
Fear of Falling Questionnaire
Description
Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
Time Frame
Week 0 and Week 8
Other Pre-specified Outcome Measures:
Title
Treatment Validation
Description
Three measures will be collected to assess the benefits of the AYT, compliance, fidelity of treatment and evaluate the participant's experience.
The Philadelphia Mindfulness Scale (PHLMS).
Practice/Homework Logs.
Treatment Fidelity.
Time Frame
Week 0, Week 4 and Week 8
Title
Physical Function
Description
Body Mass Index (BMI), systemic blood pressure, and respiratory rate, the International Physical Activity Questionnaire (IPAQ) and flexibility measures.
Time Frame
Week 0 and Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18+
Legal blindness (visual acuity worse than 20/200 but better than no/bare light perception, and/or visual field less than 20º, in the better eye)
Any ocular disease diagnosis that is expected to remain relatively stable throughout a 3-6 month period
Being healthy to the extent that participation yoga therapy would not exacerbate any existing disease conditions;
Willingness to participate on a weekly basis for the 12-week intervention;
Moderate to severe sleep disturbances, defined as ratings of 5 or greater on the PSQI
Exclusion Criteria:
Significant changes to vision within the most recent 3-month period
Inability to understand study procedures or communicate responses to visual stimuli in a consistent manner
Clinically diagnosed or clinically significant sleep disorder (e.g., sleep apnea) or a medical or psychiatric condition (e.g., chronic pain) responsible for sleep complaints;
Use of prescription sleep medication more than once a week for duration of the study;
Use of other psychotropic medication;
Current recipient of sleep disorder treatment;
Consumption of more than 2-3 alcoholic beverages per day
Smoking more than 10 cigarettes per day;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ava Bittner, PhD, OD
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
Citations:
PubMed Identifier
26107256
Citation
Jeter PE, Haaz Moonaz S, Bittner AK, Dagnelie G. Ashtanga-Based Yoga Therapy Increases the Sensory Contribution to Postural Stability in Visually-Impaired Persons at Risk for Falls as Measured by the Wii Balance Board: A Pilot Randomized Controlled Trial. PLoS One. 2015 Jun 24;10(6):e0129646. doi: 10.1371/journal.pone.0129646. eCollection 2015.
Results Reference
derived
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Yoga for Persons With Severe Visual Impairment
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