Effect of Yoga on Mood and Quality of Life in Patients With Refractory Epilepsy
2 other identifiers
interventional
3
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable depression
Started Dec 2016
Shorter than P25 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2016
CompletedFirst Posted
Study publicly available on registry
November 1, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2017
CompletedApril 30, 2018
April 1, 2018
6 months
October 28, 2016
April 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change in Generalized Anxiety Disorder 7-item (GAD-7) scale
Change from Week 4 to Week 12
Change in Quality of Life in Epilepsy-Patient-Weighted (QOLIE-31-p)
Change from Baseline to Week 12
Frequency of seizures
Week 12
Study Arms (1)
Restorative Yoga
EXPERIMENTALSubjects 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy Hammond, MD
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2016
First Posted
November 1, 2016
Study Start
December 1, 2016
Primary Completion
June 1, 2017
Study Completion
October 4, 2017
Last Updated
April 30, 2018
Record last verified: 2018-04