NCT01856335

Exercise Education for Adults With Seizure Disorders

Completed EARLY_PHASE1 Last updated 11 December 2018

What this trial tests

EARLY_PHASE1 trial testing Patient Education in Seizures in 30 participants. Completed in 7 December 2018.

Timeline

10 May 2013

Primary endpoint
25 January 2017

7 December 2018

Quick facts

Lead sponsor	National Institute of Neurological Disorders and Stroke (NINDS)
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	30
Start date	10 May 2013
Primary completion	25 January 2017
Estimated completion	7 December 2018
Sites	1 location across United States

Drugs / interventions tested

• Patient Education — full drug profile →
• exercise: increase physical activity/goal setting

Conditions studied

• Seizures — all drugs for Seizures →
• Epilepsy — all drugs for Epilepsy →

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Who can join

18 and older, any sex, with Seizures or Epilepsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.