NCT01366677

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 26, 2014

Status Verified

May 1, 2014

Enrollment Period

3.3 years

First QC Date

June 2, 2011

Last Update Submit

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

EXPERIMENTAL
Behavioral: Yoga Intervention

Interventions

Three yoga classes per week for 8 weeks.

Also known as: Yoga, Ashtanga
Yoga Therapy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

ParasomniasAnxiety DisordersDepression

Interventions

Yoga

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Ava Bittner, PhD, OD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

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

Locations