Clincosm LogoSign in Get a demo

RPY: Yoga for Persons With Severe Visual Impairment

Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT01366677
Collaborator
(none)
21
Enrollment
1
Location
1
Arm
40
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Yoga Intervention
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Development of a Yoga Intervention for Symptoms Related to Severe Visual Impairment
Study Start Date :
Aug 1, 2010
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Yoga Therapy

Behavioral: Yoga Intervention
Three yoga classes per week for 8 weeks.
Other Names:
  • Yoga, Ashtanga

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Static Balance [Week 0 and Week 8.]

      Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.

    Secondary Outcome Measures

    1. Perceived Stress Scale [Week 0 and Week 8]

      Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.

    2. Profile of Mood States - Short Form [Week 0 and Week 8]

      Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.

    3. Exit Survey [Week 8]

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

    4. Fear of Falling Questionnaire [Week 0 and Week 8]

      Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.

    Other Outcome Measures

    1. Treatment Validation [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. The Philadelphia Mindfulness Scale (PHLMS). Practice/Homework Logs. Treatment Fidelity.

    2. Physical Function [Week 0 and Week 8]

      Body Mass Index (BMI), systemic blood pressure, and respiratory rate, the International Physical Activity Questionnaire (IPAQ) and flexibility measures.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    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 20ยบ, 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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lions Vision and Research Rehabilitation Baltimore Maryland United States 21205

    Sponsors and Collaborators

    • Johns Hopkins University

    Investigators

    • Principal Investigator: Ava Bittner, PhD, OD, Johns Hopkins University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pamela Jeter, Postdoctoral Research Fellow, Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT01366677
    Other Study ID Numbers:
    • NA_00039032
    First Posted:
    Jun 6, 2011
    Last Update Posted:
    May 26, 2014
    Last Verified:
    May 1, 2014
    Additional relevant MeSH terms:
    Dyssomnias
    Parasomnias
    Vision Disorders
    Vision, Low

    Study Results

    No Results Posted as of May 26, 2014