Yoga for Persons With Severe Visual Impairment

Depression Clinical Trial

— RPY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366677
• Other study ID #: NA_00039032
• Status: Completed
• Phase: N/A
• First received: June 2, 2011
• Last updated: May 23, 2014
• Start date: August 2010
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Balance Impairment
• Depression
• Dyssomnias
• Parasomnias
• Sleep Disorders
• Sleep Disturbance
• Stress

Intervention

Behavioral:
• Yoga Intervention
Three yoga classes per week for 8 weeks.

Locations

Country	Name	City	State
United States	Lions Vision and Research Rehabilitation	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Validation	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.	Week 0, Week 4 and Week 8	No
Other	Physical Function	Body Mass Index (BMI), systemic blood pressure, and respiratory rate, the International Physical Activity Questionnaire (IPAQ) and flexibility measures.	Week 0 and Week 8	No
Primary	Static Balance	Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.	Week 0 and Week 8.	No
Secondary	Perceived Stress Scale	Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.	Week 0 and Week 8	No
Secondary	Profile of Mood States - Short Form	Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.	Week 0 and Week 8	No
Secondary	Exit Survey	The exist survey is administered immediately after the intervention during Week 8.	Week 8	Yes
Secondary	Fear of Falling Questionnaire	Measures will be assessed at baseline (Week 0) and immediately after the 8-week intervention at Week 8.	Week 0 and Week 8	No