We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Yoga for Persons With Severe Visual Impairment (RPY)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01366677
First Posted: June 6, 2011
Last Update Posted: May 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pamela Jeter, Johns Hopkins University
June 2, 2011
June 6, 2011
May 26, 2014
August 2010
December 2013   (Final data collection date for primary outcome measure)
Static Balance [ Time Frame: Week 0 and Week 8. ]
Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
Pittsburgh Sleep Quality Index [ Time Frame: Week 0 and Week 8. ]
Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
Complete list of historical versions of study NCT01366677 on ClinicalTrials.gov Archive Site
  • Perceived Stress Scale [ Time Frame: Week 0 and Week 8 ]
    Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
  • Profile of Mood States - Short Form [ Time Frame: Week 0 and Week 8 ]
    Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
  • Exit Survey [ Time Frame: Week 8 ]
    The exist survey is administered immediately after the intervention during Week 8.
  • Fear of Falling Questionnaire [ Time Frame: Week 0 and Week 8 ]
    Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
  • Perceived Stress Scale [ Time Frame: Week 0 and Week 8 ]
    Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
  • Becks Anxiety Index [ Time Frame: Week 0 and Week 8 ]
    Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
  • Becks Depression Index [ Time Frame: Week 0 and Week 8 ]
    Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
  • Timed One-Legged Stance [ Time Frame: Week 0 and Week 8 ]
    Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.
  • Exit Survey [ Time Frame: Week 8 ]
    The exist survey is administered immediately after the intervention during Week 8.
  • Treatment Validation [ Time Frame: Week 0, Week 4 and Week 8 ]

    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.
  • Physical Function [ Time Frame: Week 0 and Week 8 ]
    Body Mass Index (BMI), systemic blood pressure, and respiratory rate, the International Physical Activity Questionnaire (IPAQ) and flexibility measures.
Not Provided
 
Yoga for Persons With Severe Visual Impairment
Development of a Yoga Intervention for Symptoms Related to Severe Visual Impairment
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.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Sleep Disturbance
  • Stress
  • Anxiety
  • Depression
  • Balance Impairment
Behavioral: Yoga Intervention
Three yoga classes per week for 8 weeks.
Other Name: Yoga, Ashtanga
Experimental: Yoga Therapy
Intervention: Behavioral: Yoga Intervention
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
December 2013
December 2013   (Final data collection date for primary outcome measure)

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;
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01366677
NA_00039032
No
Not Provided
Not Provided
Pamela Jeter, Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Ava Bittner, PhD, OD Johns Hopkins University
Johns Hopkins University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP