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Completed

NCT Number: NCT02950636

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

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).

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Epilepsy Mental Disorders Nervous System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

yoga

Other

Restorative Yoga

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Frequency of seizures

    Time frame: Week 12

    Count of seizures in study subjects

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 1, 2016
Registry last updated
Apr 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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