EpilepsyNCT03814174
Comparison of Physical Fitness and Activities of the Children With Epilepsy and Their Healthy Peers
An observational study of Epilepsy and Physical Activity, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
To investigate physical fitness and activity levels in children with epilepsy and compare the results with healthy peers. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Physical Activity
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Oct 2017to 30 May 2018
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population will consist of children with epilepsy and their healthy peers.
Who may be able to join
- children who were diagnosed with epilepsy
- children who can independently continue formal education,
- children who do not need special education
- children who have no additional neurological and neuromuscular disease (epilepsy only)
- children who have a normal or higher cognitive level according to the WISC-R intelligence test
- children who were volunteers to participate in the study
- children whose parents volunteers to participate in the study
Who cannot join
- The disappearance of volunteerism
Trial locations and contacts
1 site in 1 country.
About this study
To investigate physical fitness and activity levels in children with epilepsy and compare the results with healthy peers.
Read the detailed description
Many individuals with epilepsy are physically inactive due to the fear of seizures triggered by physical activity/ exercise, and the advices given by the family members and the health care professionals to avoid intense activity . In two studies performed about this subject, this is the probable reason why adult patients with epilepsy have a weaker physical fitness than healthy individuals in the control group. However; in a study of Drawskowski et al., the avoidance of activity and exercise in individuals with epilepsy was investigated, and it was reported that the injuries and seizure problems were rare even during very intense physical activity.
- Conditions
- Epilepsy, Physical Activity
- Keywords
- Childhood Epilepsy, Physical Fitness, Physical Activity, Use of Pedometer
- Medical subject headings
- Epilepsy, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steps on pedometer
Participants will wear a pedometer (physical activity monitor) for seven consecutive days.
Measured: seven days
Exercise performance using 6-minute walk test
6-minute walk test will be performed in a long, straight, enclosed corridor 30 meters in length. Patients are required to walk in their walking speed with standardized instructions. The distance walked by subjects during 6 minutes will be recorded.
Measured: 1st day (before using device)
Health-Related Physical Fitness Test for body compozition
body mass index
Measured: 1st day (before using device)
Health-Related Physical Fitness Test for strenght
Cadance Based Curl-up Test
Measured: 1st day (before using device)
Health-Related Physical Fitness Test for balance
Flamingo Balance Test
Measured: 1st day (before using device)
Health-Related Physical Fitness Test for flexibility
Sit and Reach Test
Measured: 1st day (before using device)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start24 Oct 2017
- Primary completion20 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsen SIRTBAS, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814174
- Sponsor's protocol ID
- 17/751
- Status last verified
- Mar 2019
- First submitted
- 18 Jan 2019
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Physical Fitness and Activities of the Children With Epilepsy and Their Healthy Peers
- ClinicalTrials.gov ID
- NCT03814174
- Acronym / sponsor ID
- 17/751
- Conditions
- Epilepsy, Physical Activity
- Keywords
- Childhood Epilepsy, Physical Fitness, Physical Activity, Use of Pedometer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 20 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 23 Jan 2019 (actual)
- 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.
To investigate physical fitness and activity levels in children with epilepsy and compare the results with healthy peers.
Detailed description
Many individuals with epilepsy are physically inactive due to the fear of seizures triggered by physical activity/ exercise, and the advices given by the family members and the health care professionals to avoid intense activity . In two studies performed about this subject, this is the probable reason why adult patients with epilepsy have a weaker physical fitness than healthy individuals in the control group. However; in a study of Drawskowski et al., the avoidance of activity and exercise in individuals with epilepsy was investigated, and it was reported that the injuries and seizure problems were rare even during very intense physical activity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population will consist of children with epilepsy and their healthy peers.
Key inclusion criteria (7 listed)
- children who were diagnosed with epilepsy
- children who can independently continue formal education,
- children who do not need special education
- children who have no additional neurological and neuromuscular disease (epilepsy only)
- children who have a normal or higher cognitive level according to the WISC-R intelligence test
Key exclusion criteria (1 listed)
- The disappearance of volunteerism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of steps on pedometer
Time frame: seven days
Participants will wear a pedometer (physical activity monitor) for seven consecutive days.
Exercise performance using 6-minute walk test
Time frame: 1st day (before using device)
6-minute walk test will be performed in a long, straight, enclosed corridor 30 meters in length. Patients are required to walk in their walking speed with standardized instructions. The distance walked by subjects during 6 minutes will be recorded.
Health-Related Physical Fitness Test for body compozition
Time frame: 1st day (before using device)
body mass index
Health-Related Physical Fitness Test for strenght
Time frame: 1st day (before using device)
Cadance Based Curl-up Test
Health-Related Physical Fitness Test for balance
Time frame: 1st day (before using device)
Flamingo Balance Test
Health-Related Physical Fitness Test for flexibility
Time frame: 1st day (before using device)
Sit and Reach Test
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 13 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Physical Activity, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 7 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 13 Mar 2019. 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 Turkey (Türkiye). 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.
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?
Number of steps on pedometer (time frame: seven days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2019.