Back to resultsYoga for Patients With Epilepsy
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
About this trial
This is an interventional other trial for Epilepsy focused on measuring epilepsy, yoga
Eligibility Criteria
Inclusion Criteria: Must be able to give full informed consent. Must have one or more of the following seizure types: simple partial, complex partial, or secondarily generalized. Age 18-64. Must have 4-20 during the baseline phase. Must have medical clearance from their primary care giver sufficient to allow for participation in yoga exercises. Must be stable enough to allow for all anticonvulsant levels to remain constant for the duration of the study. Exclusion Criteria: Having primary generalized epilepsy or atonic seizures. Having a history of status epilepticus in the past two years. Any medical problem that would preclude participation in a yoga class. Nonepileptic or psychogenic seizures. Pregnancy.
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Subjects invited to participate in yoga practice.
Outcomes
Primary Outcome Measures
Improvement in quality of life assessments.
Improvement in mood.
Secondary Outcome Measures
Improvement in seizure control.
Full Information
NCT ID
NCT00179452
First Posted
September 13, 2005
Last Updated
March 9, 2017
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00179452
Brief Title
Yoga for Patients With Epilepsy
Official Title
Is Yoga Safe for Patients With Epilepsy?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To establish the safety and feasibility of having patients with epilepsy perform yoga.
Detailed Description
Subjects will keep logs of seizure frequency prior to, during, and following training in a yoga regimen. Instruction in the yoga regimen will occur at BIDMC, and home practice following classroom instruction will occur as part of the study. Side effects, changes in seizure frequency, and quality of life assessments will be performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
epilepsy, yoga
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Subjects invited to participate in yoga practice.
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Primary Outcome Measure Information:
Title
Improvement in quality of life assessments.
Time Frame
3 months
Title
Improvement in mood.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Improvement in seizure control.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be able to give full informed consent.
Must have one or more of the following seizure types: simple partial, complex partial, or secondarily generalized.
Age 18-64.
Must have 4-20 during the baseline phase.
Must have medical clearance from their primary care giver sufficient to allow for participation in yoga exercises.
Must be stable enough to allow for all anticonvulsant levels to remain constant for the duration of the study.
Exclusion Criteria:
Having primary generalized epilepsy or atonic seizures.
Having a history of status epilepticus in the past two years.
Any medical problem that would preclude participation in a yoga class.
Nonepileptic or psychogenic seizures.
Pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaarkuzhali Krishanmurthy, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share as was not included in original protocol as approved by the IRB, so subject consent was not obtained.
Learn more about this trial
Yoga for Patients With Epilepsy
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