Exercise Education for Adults With Seizure Disorders
Primary Purpose
Seizures, Epilepsy
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Patient Education
exercise: increase physical activity/goal setting
Sponsored by
About this trial
This is an interventional other trial for Seizures focused on measuring Seizures, Epilepsy
Eligibility Criteria
- INCLUSION CRITERIA:
Able to use seizure calendars to record seizures throughout the study
English speaking
Able to provide informed consent
Diagnosed with epilepsy by standard clinical criteria.
Age 18 years and older
Enrolled in evaluation and treatment of epilepsy protocol 01-N-0139
EXCLUSION CRITERIA:
Do not have health care provider clearance to participate in a physical activity program
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Outcomes
Primary Outcome Measures
Change in Self-efficacy for exercise score following the E-MOVE intervention.
Change in Outocme Expectations for exercise score following the E-MOVE intervention.
Secondary Outcome Measures
The effect of the E-MOVE intervention on seizure frequency based on seizure calendar self-report, quality of life scores, symptoms of depression and BMI measures.
Full Information
NCT ID
NCT01856335
First Posted
May 10, 2013
Last Updated
December 8, 2018
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01856335
Brief Title
Exercise Education for Adults With Seizure Disorders
Official Title
Increasing Self-Efficacy and Outcome Expectations For Exercise in Adults With Epilepsy: An Educational Motivation Intervention - E-MOVE
Study Type
Interventional
2. Study Status
Record Verification Date
December 7, 2018
Overall Recruitment Status
Completed
Study Start Date
May 10, 2013 (undefined)
Primary Completion Date
January 25, 2017 (Actual)
Study Completion Date
December 7, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
Brief Summary
Study Population
-People with seizures benefit from regular exercise. Exercise may help decrease the number of seizures they have. It also improves overall health and quality of life. However, people with seizure disorders often have been prevented from doing sports or other regular physical activity. They may also feel that exercise or injury can increase their risk of seizures. Researchers want to try an exercise program for people who have seizures to see if they can increase motivation to exercise which will improve overall health and may decrease the frequency of seizures.
Objectives:
- To see how exercise education improves motivation to exercise in people who have a history of seizures.
Eligibility:
- Individuals at least 18 years of age who have a history of seizures.
Design:
This study involves three outpatient visits and weekly telephone calls for about 12 weeks. There will be followup calls at about 6 and 12 months after the outpatient visits.
Participants will be screened with a physical exam and medical history. They will answer questions about their current level of physical activity, mood, quality of life, and ideas about exercise.
At the first visit, participants will learn how to keep a physical activity log and seizure calendar. They will also use an activity monitor and take their pulse regularly. They will complete questionnaires about their mood and thoughts about exercise and seizures.
At the second visit, participants will set personal activity goals and learn about physical activity and seizures. They will review the physical activity log, seizure log, and activity monitor and pulse readings for the previous 4 weeks.
After the second visit, participants will receive weekly telephone calls. Each call will last about 5 minutes. These calls will ask about physical activities for the week and participants' progress toward meeting their goals. These calls will also review the seizure log.
At the third visit (12 weeks), the same tests from the first visit will be repeated.
The followup phone calls will continue to monitor participants' activity levels.
Detailed Description
Objective:
To see what keeps people with seizures from exercising and see how they can increase their belief that they can exercise and that exercise will help them.
Study Population:
50 adults with seizures
Design:
In this protocol, we will pilot the use of an educational intervention to provide people with seizure disorders an opportunity to learn about the benefits of exercise and learn specifically what types of exercise to incorporate into their daily lives.
Outcome Measures:
To assess the effectiveness of the educational intervention, we will use pre and post intervention measures including seizure specific measures of self-efficacy (belief that they can exercise) and outcome expectations (belief that exercise will help them) for exercise. To assess changes in physical activity, seizure frequency, and mood, we will monitor physical activity and seizure calendars, activity monitor recordings, and mood rating scales.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures, Epilepsy
Keywords
Seizures, Epilepsy
7. Study Design
Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Patient Education
Intervention Type
Other
Intervention Name(s)
exercise: increase physical activity/goal setting
Primary Outcome Measure Information:
Title
Change in Self-efficacy for exercise score following the E-MOVE intervention.
Time Frame
0 and 12 weeks post intervention
Title
Change in Outocme Expectations for exercise score following the E-MOVE intervention.
Time Frame
0 and 12 weeks post intervention
Secondary Outcome Measure Information:
Title
The effect of the E-MOVE intervention on seizure frequency based on seizure calendar self-report, quality of life scores, symptoms of depression and BMI measures.
Time Frame
0 and 12 weeks post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA:
Able to use seizure calendars to record seizures throughout the study
English speaking
Able to provide informed consent
Diagnosed with epilepsy by standard clinical criteria.
Age 18 years and older
Enrolled in evaluation and treatment of epilepsy protocol 01-N-0139
EXCLUSION CRITERIA:
Do not have health care provider clearance to participate in a physical activity program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene H Dustin, C.R.N.P.
Organizational Affiliation
National Institute of Neurological Disorders and Stroke (NINDS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18557661
Citation
Arida RM, Cavalheiro EA, da Silva AC, Scorza FA. Physical activity and epilepsy: proven and predicted benefits. Sports Med. 2008;38(7):607-15. doi: 10.2165/00007256-200838070-00006.
Results Reference
background
PubMed Identifier
19037323
Citation
Arida RM, Scorza CA, Schmidt B, de Albuquerque M, Cavalheiro EA, Scorza FA. Physical activity in sudden unexpected death in epilepsy: much more than a simple sport. Neurosci Bull. 2008 Dec;24(6):374-80. doi: 10.1007/s12264-008-0805-z.
Results Reference
background
PubMed Identifier
20618406
Citation
Arida RM, Scorza FA, Cavalheiro EA. Favorable effects of physical activity for recovery in temporal lobe epilepsy. Epilepsia. 2010 Jul;51 Suppl 3:76-9. doi: 10.1111/j.1528-1167.2010.02615.x.
Results Reference
background
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Exercise Education for Adults With Seizure Disorders
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