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Completed

NCT Number: NCT01366677

Yoga for Persons With 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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lions Vision and Research Rehabilitation

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Yoga intervention

Behavioral

Three yoga classes per week for 8 weeks.

Other names: Yoga, Ashtanga

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Exit Survey

    Time frame: Week 8

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

  4. 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.

Other outcomes

  1. 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.

    • The Philadelphia Mindfulness Scale (PHLMS).
    • Practice/Homework Logs.
    • Treatment Fidelity.
  2. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Development of a Yoga Intervention for Symptoms Related to Severe Visual Impairment

Acronym: RPY

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 6, 2011
Registry last updated
May 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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