SeizuresEarly Phase 1NCT01856335
Exercise Education for Adults With Seizure Disorders
A Early Phase 1 study testing Patient Education and exercise: increase physical activity/goal setting in people with Seizures and Epilepsy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Patient Education and exercise: increase physical activity/goal setting
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2013to 7 Dec 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Do not have health care provider clearance to participate in a physical activity program
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Patient Education, exercise: increase physical activity/goal setting
- Keywords
- Seizures, Epilepsy
- Medical subject headings
- Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient EducationOther
exercise: increase physical activity/goal settingOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-efficacy for exercise score following the E-MOVE intervention.
Measured: 0 and 12 weeks post intervention
Change in Outocme Expectations for exercise score following the E-MOVE intervention.
Measured: 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.
Measured: 0 and 12 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study start10 May 2013
- Primary completion25 Jan 2017
- Study completion7 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SeizuresStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Irene H Dustin, C.R.N.P., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856335
- Sponsor's protocol ID
- 130127
- Other IDs
- 13-N-0127
- Status last verified
- 7 Dec 2018
- First submitted
- 10 May 2013
- Last updated
- 11 Dec 2018
- Results posted
- No
Publications
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.
PubMed 18557661Arida 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.
PubMed 19037323Arida 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.
PubMed 20618406
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Self-Efficacy and Outcome Expectations For Exercise in Adults With Epilepsy: An Educational Motivation Intervention - E-MOVE
- ClinicalTrials.gov ID
- NCT01856335
- Acronym / sponsor ID
- 130127
- Keywords
- Seizures, Epilepsy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 10 May 2013
- Primary completion
- 25 Jan 2017 (actual)
- Study completion
- 7 Dec 2018 (actual)
- First posted
- 17 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Do not have health care provider clearance to participate in a physical activity program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Education | Other | – |
| exercise: increase physical activity/goal setting | Other | – |
Primary outcome
Change in Self-efficacy for exercise score following the E-MOVE intervention.
Time frame: 0 and 12 weeks post intervention
Change in Outocme Expectations for exercise score following the E-MOVE intervention.
Time frame: 0 and 12 weeks post intervention
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Background: PubMed 18557661Arida 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.
- Background: PubMed 19037323Arida 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.
- Background: PubMed 20618406Arida 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene H Dustin, C.R.N.P. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Patient Education and exercise: increase physical activity/goal setting in people with Seizures and Epilepsy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-efficacy for exercise score following the E-MOVE intervention. (time frame: 0 and 12 weeks post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01856335, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.