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

April 26, 2018 updated by: University of Kansas Medical Center
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Restorative 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.
Other: Yoga
Restorative Yoga

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)
Time Frame: 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.
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
Time Frame: 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 from Week 4 to Week 12
Change in Quality of Life in Epilepsy-Patient-Weighted (QOLIE-31-p)
Time Frame: 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.
Change from Baseline to Week 12
Frequency of seizures
Time Frame: Week 12
Count of seizures in study subjects
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

October 4, 2017

Study Registration Dates

First Submitted

October 28, 2016

First Submitted That Met QC Criteria

October 28, 2016

First Posted (Estimate)

November 1, 2016

Study Record Updates

Last Update Posted (Actual)

April 30, 2018

Last Update Submitted That Met QC Criteria

April 26, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00140045
  • UL1TR000001 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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