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Exercise Education for Adults With Seizure Disorders

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.

Studieoversikt

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

30

Fase

  • Tidlig fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Maryland
      • Bethesda, Maryland, Forente stater, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

  • 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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tidsramme
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.
Tidsramme: 0 and 12 weeks post intervention
0 and 12 weeks post intervention

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

10. mai 2013

Primær fullføring (Faktiske)

25. januar 2017

Studiet fullført (Faktiske)

7. desember 2018

Datoer for studieregistrering

Først innsendt

10. mai 2013

Først innsendt som oppfylte QC-kriteriene

14. mai 2013

Først lagt ut (Anslag)

17. mai 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. desember 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. desember 2018

Sist bekreftet

7. desember 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 130127
  • 13-N-0127

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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