Clinical trial NCT01366677: Yoga for Persons With Severe Visual Impairment
Official title: Development of a Yoga Intervention for Symptoms Related to Severe Visual Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Stress
Anxiety
Depression
Balance Impairment
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2011-06-06
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Static Balance
timeFrame: Week 0 and Week 8.
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: Week 0 and Week 8
measure: Profile of Mood States - Short Form
timeFrame: Week 0 and Week 8
measure: Exit Survey
timeFrame: Week 8
measure: Fear of Falling Questionnaire
timeFrame: Week 0 and Week 8
Other outcomes:
measure: Treatment Validation
timeFrame: Week 0, Week 4 and Week 8
measure: Physical Function
timeFrame: Week 0 and Week 8
Locations:
city: Baltimore
country: United States
facility: Lions Vision and Research Rehabilitation
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Ava Bittner, PhD, OD
role: PRINCIPAL_INVESTIGATOR
References:
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.