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

Study Overview
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Brief Summary
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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).

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

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Other: Yoga


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restorative Yoga<br>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. | Other: Yoga<br>* Restorative Yoga<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Frequency of seizures | Count of seizures in study subjects | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy