Yoga for Persons With Severe Visual Impairment
RPY
Development of a Yoga Intervention for Symptoms Related to Severe Visual Impairment
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 2, 2011
CompletedFirst Posted
Study publicly available on registry
June 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMay 26, 2014
May 1, 2014
3.3 years
June 2, 2011
May 23, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Static Balance
Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
Week 0 and Week 8.
Secondary Outcomes (4)
Perceived Stress Scale
Week 0 and Week 8
Profile of Mood States - Short Form
Week 0 and Week 8
Exit Survey
Week 8
Fear of Falling Questionnaire
Week 0 and Week 8
Other Outcomes (2)
Treatment Validation
Week 0, Week 4 and Week 8
Physical Function
Week 0 and Week 8
Study Arms (1)
Yoga Therapy
EXPERIMENTALInterventions
Three yoga classes per week for 8 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lions Vision and Research Rehabilitation
Baltimore, Maryland, 21205, United States
Related Publications (1)
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.
PMID: 26107256DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ava Bittner, PhD, OD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postdoctoral Research Fellow
Study Record Dates
First Submitted
June 2, 2011
First Posted
June 6, 2011
Study Start
August 1, 2010
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
May 26, 2014
Record last verified: 2014-05