search
Back to results

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

Primary Purpose

Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Epilepsy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Restorative Yoga

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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.
Frequency of seizures
Count of seizures in study subjects

Full Information

First Posted
October 28, 2016
Last Updated
April 26, 2018
Sponsor
University of Kansas Medical Center
Collaborators
National Institutes of Health (NIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT02950636
Brief Title
Effect of Yoga on Mood and Quality of Life in Patients With Refractory Epilepsy
Official Title
Effect of Yoga on Mood and Quality of Life in Patients With Refractory Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
October 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Institutes of Health (NIH)

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
Epilepsy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Restorative Yoga
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
Restorative Yoga
Primary Outcome Measure Information:
Title
Change in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)
Description
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.
Time Frame
Change from Week 4 to Week 12
Secondary Outcome Measure Information:
Title
Change in Generalized Anxiety Disorder 7-item (GAD-7) scale
Description
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.
Time Frame
Change from Week 4 to Week 12
Title
Change in Quality of Life in Epilepsy-Patient-Weighted (QOLIE-31-p)
Description
The QOLIE-31-p is a 38 item questionnaire. Scores range from 0-100. Higher scores relate to higher distress.
Time Frame
Change from Baseline to Week 12
Title
Frequency of seizures
Description
Count of seizures in study subjects
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Hammond, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs