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

Not Applicable

Completed

• Conditions: Depression; Anxiety
• Interventions: Other: Yoga

• Registration Number: NCT02950636
• Lead Sponsor: University of Kansas Medical Center

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-28
• Study First Submitted QC: 2016-10-28
• Study First Posted: 2016-11-01
• Study Start: 2016-12
• Primary Completion: 2017-06
• Study Completion: 2017-10-04
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-26
• Last Update Posted: 2018-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Restorative Yoga	Yoga	Subjects will participate in a structured restorative yoga program. Subjects will attend a 60 minute restorative yoga class twice a week for 8 weeks in a yoga studio.

Primary Outcome Measures

Name	Time	Method
Change in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)	Change from Week 4 to Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Change in Generalized Anxiety Disorder 7-item (GAD-7) scale	Change from Week 4 to Week 12	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 in Quality of Life in Epilepsy-Patient-Weighted (QOLIE-31-p)	Change from Baseline to Week 12	The QOLIE-31-p is a 38 item questionnaire. Scores range from 0-100. Higher scores relate to higher distress.
Frequency of seizures	Week 12	Count of seizures in study subjects

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States