Exercise Education for Adults With Seizure Disorders

NCT01856335 | Completed Early Phase 1

• 2 other identifiers: 13012713-N-0127
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Seizures; Epilepsy

Keywords

Seizures; Epilepsy

Outcome Measures

Primary Outcomes (2)

• Change in Self-efficacy for exercise score following the E-MOVE intervention.

  0 and 12 weeks post intervention

• Change in Outocme Expectations for exercise score following the E-MOVE intervention.

  0 and 12 weeks post intervention

Secondary Outcomes (1)

• 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.

  0 and 12 weeks post intervention

Interventions

Patient Education OTHER

exercise: increase physical activity/goal setting OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Do not have health care provider clearance to participate in a physical activity program

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 18557661 BACKGROUND

• 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.

  PMID: 19037323 BACKGROUND

• 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.

  PMID: 20618406 BACKGROUND

MeSH Terms

Conditions

Seizures; Epilepsy

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Irene H Dustin, C.R.N.P.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 17, 2013
• Study Start: May 10, 2013
• Primary Completion: January 25, 2017
• Study Completion: December 7, 2018
• Last Updated: December 11, 2018

Record last verified: 2018-12-07

Locations

US (1)