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Yoga for Persons With Severe Visual Impairment (RPY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pamela Jeter, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01366677
First received: June 2, 2011
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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 Intervention
Sleep Disturbance
Stress
Anxiety
Depression
Balance Impairment
Behavioral: Yoga Intervention

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development of a Yoga Intervention for Symptoms Related to Severe Visual Impairment

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Static Balance [ Time Frame: Week 0 and Week 8. ] [ Designated as safety issue: No ]
    Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.


Secondary Outcome Measures:
  • Perceived Stress Scale [ Time Frame: Week 0 and Week 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.

  • Exit Survey [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
    The exist survey is administered immediately after the intervention during Week 8.

  • Fear of Falling Questionnaire [ Time Frame: Week 0 and Week 8 ] [ Designated as safety issue: No ]
    Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.


Other Outcome Measures:
  • Treatment Validation [ Time Frame: Week 0, Week 4 and Week 8 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Body Mass Index (BMI), systemic blood pressure, and respiratory rate, the International Physical Activity Questionnaire (IPAQ) and flexibility measures.


Enrollment: 21
Study Start Date: August 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yoga Therapy Behavioral: Yoga Intervention
Three yoga classes per week for 8 weeks.
Other Name: Yoga, Ashtanga

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366677

Locations
United States, Maryland
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
  More Information

No publications provided

Responsible Party: Pamela Jeter, Postdoctoral Research Fellow, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01366677     History of Changes
Other Study ID Numbers: NA_00039032
Study First Received: June 2, 2011
Last Updated: May 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Dyssomnias
Parasomnias
Sleep Disorders
Behavioral Symptoms
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014