Yoga for Persons With Severe Visual Impairment (RPY)
This study is currently recruiting participants.
Verified October 2012 by Johns Hopkins University
Sponsor:
Johns Hopkins University
Information provided by (Responsible Party):
Pamela Jeter, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01366677
First received: June 2, 2011
Last updated: October 31, 2012
Last verified: October 2012
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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, 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.
- The Philadelphia Mindfulness Scale (PHLMS).
- Practice/Homework Logs.
- 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.
| Estimated Enrollment: | 25 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | July 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
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366677
Contacts
| Contact: Pamela Jeter, PhD | 410-502-6434 | pjeter1@jhmi.edu |
| Contact: Ava Bittner, PhD | 410-502 6430 | abittne1@jhmi.edu |
Locations
| United States, Maryland | |
| Lions Vision and Research Rehabilitation | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Contact: Pamela Jeter, PhD 410-502-6434 pjeter1@jhmi.edu | |
| Sub-Investigator: Pamela E Jeter, PhD | |
| Principal Investigator: Ava Bittner, PhD, OD | |
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: | October 31, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Anxiety Disorders Depression Depressive Disorder Sleep Disorders Dyssomnias Parasomnias Vision, Low Vision Disorders |
Mental Disorders Behavioral Symptoms Mood Disorders Nervous System Diseases Neurologic Manifestations Signs and Symptoms Sensation Disorders Eye Diseases |
ClinicalTrials.gov processed this record on May 21, 2013