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Exercise Education for Adults With Seizure Disorders

8 december 2018 bijgewerkt door: National Institute of Neurological Disorders and Stroke (NINDS)

Increasing Self-Efficacy and Outcome Expectations For Exercise in Adults With Epilepsy: An Educational Motivation Intervention - E-MOVE

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

Fase

Vroege fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- Maryland
  - Bethesda, Maryland, Verenigde Staten, 20892
    - National Institutes of Health Clinical Center, 9000 Rockville Pike

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Ander
Toewijzing: NVT
Interventioneel model: Opdracht voor een enkele groep
Masker: Geen (open label)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
Change in Self-efficacy for exercise score following the E-MOVE intervention. Tijdsspanne: 0 and 12 weeks post intervention	0 and 12 weeks post intervention
Change in Outocme Expectations for exercise score following the E-MOVE intervention. Tijdsspanne: 0 and 12 weeks post intervention	0 and 12 weeks post intervention

Secundaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
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. Tijdsspanne: 0 and 12 weeks post intervention	0 and 12 weeks post intervention

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Medewerkers

National Institute of Mental Health (NIMH)

Onderzoekers

Hoofdonderzoeker: Irene H Dustin, C.R.N.P., National Institute of Neurological Disorders and Stroke (NINDS)

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

10 mei 2013

Primaire voltooiing (Werkelijk)

25 januari 2017

Studie voltooiing (Werkelijk)

7 december 2018

Studieregistratiedata

Eerst ingediend