Effect of Yoga on Mood and Quality of Life in Patients With Refractory Epilepsy

Depression Clinical Trial

Official title:

Effect of Yoga on Mood and Quality of Life in Patients With Refractory Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02950636
• Other study ID #: STUDY00140045
• Secondary ID: UL1TR000001
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: October 4, 2017

Study information

• Verified date: April 2018
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to learn if a structured yoga program can reduce anxiety, improve depression, and improve quality of life in patients with medication resistant epilepsy (MRE).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: October 4, 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of unilateral or bilateral temporal lobe epilepsy

• Presence 3 or more seizures per month

• No medical contraindications to yoga

• Willing and able to perform simple non strenuous yoga exercises

• Ability to get on the floor and up again without assistance

• Ambulatory

• Ability to travel to the yoga class twice a week

Exclusion Criteria:

• Any yoga in the last 6 months

• Inability to perform yoga exercises

• History of epilepsy surgery within the last year

• Currently pregnant or less than 6 week postpartum

Related Conditions & MeSH terms

• Anxiety
• Depression
• Drug Resistant Epilepsy
• Epilepsy

Intervention

Other:
• Yoga
Restorative Yoga

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)	The NDDI-E is a 6 item questionnaire. Scores for each question range from 1 (never) to 4 (all the time). There is a maximum score of 24. The higher the score the more severe the depression.	Change from Week 4 to Week 12
Secondary	Change in Generalized Anxiety Disorder 7-item (GAD-7) scale	The GAD-7 is a 7 item questionnaire. Scores for each question range from 0 (not at all) to 3 (nearly every day). There is a maximum score of 21. The higher the score the more severe the anxiety. A score over 15 represents severe anxiety. A score under 10 may indicate GAD and would prompt further examination.	Change from Week 4 to Week 12
Secondary	Change in Quality of Life in Epilepsy-Patient-Weighted (QOLIE-31-p)	The QOLIE-31-p is a 38 item questionnaire. Scores range from 0-100. Higher scores relate to higher distress.	Change from Baseline to Week 12
Secondary	Frequency of seizures	Count of seizures in study subjects	Week 12