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CompletedNCT01366677RPYUpdated May 26, 2014

Yoga for Persons With Severe Visual Impairment

An interventional study of Yoga Intervention in Sleep Disturbance, Stress and Anxiety, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-26.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Sleep Disturbance
  • Stress
  • Anxiety
  • Depression
  • Balance Impairment
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In context

Vision Disorders

308 studies on the registry are indexed under Vision Disorders; 81 are open to participants now.

This study's enrollment of 21 is below the median of 66 across 211 interventional studies indexed under Vision Disorders.

Browse Vision Disorders studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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;
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Yoga Therapy

    Behavioral: Yoga Intervention

Interventions

  • BehavioralYoga Intervention

    Three yoga classes per week for 8 weeks.

    Also known as: Yoga, Ashtanga

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What researchers measure

Primary outcomes

  1. Static Balance

    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 outcomes

  1. Perceived Stress Scale

    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

  2. Profile of Mood States - Short Form

    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

  3. Exit Survey

    The exist survey is administered immediately after the intervention during Week 8.

    Time frame: Week 8

  4. Fear of Falling Questionnaire

    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 outcomes

  1. Treatment Validation

    Three measures will be collected to assess the benefits of the AYT, compliance, fidelity of treatment and evaluate the participant's experience. 1. The Philadelphia Mindfulness Scale (PHLMS). 2. Practice/Homework Logs. 3. Treatment Fidelity.

    Time frame: Week 0, Week 4 and Week 8

  2. Physical Function

    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

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Study locations

1 site
  • Lions Vision and Research Rehabilitation
    Baltimore, Maryland 21205, United States
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References and documents

Publications

  • 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. PubMed 26107256 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01366677
Lead sponsor
Johns Hopkins University
Responsible party
Pamela Jeter (Postdoctoral Research Fellow, Johns Hopkins University) — Principal investigator
First posted
Jun 6, 2011
Start date
Aug 2010
Primary completion
Dec 2013
Completion
Dec 2013
Last update
May 26, 2014

Study contacts

Ava Bittner, PhD, OD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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