EpilepsySTEPNCT01550874
STEP: Enhanced Physical Activity in Children and Youth With Epilepsy
A study testing Physical activity behavior-change counselling in people with Epilepsy, run by McMaster University at 2 sites in Canada.
Trial summary
Epilepsy is common in childhood. Children with epilepsy are at increased risk of impaired health, functioning, psychological well-being, and quality of life. There is compelling evidence that physical activity improves the medical and psychosocial aspects of health in adults with epilepsy - but there are no such… Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Physical activity behavior-change counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesCanada
- Study dates
- 2 Apr 2012to 31 Mar 2018
- Phase
- Interventional
- 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 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Has epilepsy, as confirmed by a pediatric neurologist, with at least 1 seizure in the previous 12 months
- Ambulatory
- Fluency English or French
- Intellectual functioning at or greater than grade 3 level, as judged by parents
- Access to a computer
Who cannot join
- Additional diagnoses of psychogenic seizures or autism
- Enrolled in a potentially confounding trial
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McMaster Children's Hospital
Hamilton, Ontario, L8S 4K1
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
About this study
Official title: STEP: Enhanced Physical Activity in Children and Youth With Epilepsy: Developing Evidence of Impacts on Health, Functioning, Psychological Wellbeing, and Quality of Life
Epilepsy is common in childhood. Children with epilepsy are at increased risk of impaired health, functioning, psychological well-being, and quality of life. There is compelling evidence that physical activity improves the medical and psychosocial aspects of health in adults with epilepsy - but there are no such studies in children. This study is to see if increased levels of physical activity can influence children's functioning, psychological well-being, and quality of life.
Read the detailed description
There are many unfounded assumptions about the dangers of exercise in children with epilepsy - assumptions that may be seriously detrimental to children's health, and that we have good reason to challenge. This project explores the innovative idea that enhancing physical activity in children with epilepsy will have a positive effect on medical and psychosocial outcomes. The primary purpose of this study is to examine whether increasing physical activity levels through a six-month walking program, that includes behavioral counselling and self-monitoring of physical activity, as compared to varied un-standardized current practices, positively influences health and quality of life over one year. The secondary purposes are to (i) determine which environmental and personal facilitators and barriers to physical activity are experienced when increasing physical activity levels through a six-month walking program; (ii) determine if physical activity levels established during the six-month program will be sustained over a subsequent six-month period that includes self-monitoring of physical activity only; (iii) identify aspects of health that are amendable to change with enhanced physical activity, and explore the relationships among physical activity and impairments, functioning, psychological well-being and quality of life; and (iv) assess if there is a dose-response relationship between physical activity and a variety of health and social factors and quality of life.
- Conditions
- Epilepsy
- Being tested
- Physical activity behavior-change counselling
- Keywords
- Physical Activity, Epilepsy, Children, Motivation
- Medical subject headings
- Epilepsy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity behavior-change counsellingBehavioural
Participants in the experimental group will be motivated by augmented behavior modification strategies aiming to increase performance by: (i) having access to the pedometer web page that allows them to view their automatically calculated goals, and (ii) get feedback about performance toward goals.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Wear the pedometer provided by study everyday with weekly charging and syncing of data. |
| Experimental Group | Experimental | Wear the pedometer provided by the study everyday and also participate in phone-based physical activity behavior-change counselling for 6 months and then check sustainability without further motivational support for another 6 months. Receives: Behavioral: Physical activity behavior-change counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
CHEQOL-25
Measure of quality of life
Measured: Baseline, 16 week follow-up, 28 week follow-up
KIDSCREEN-27
Will look at Psychological Well-Being (7items) subscale
Measured: Baseline, 16 week follow-up, 28 week follow-up
Step Count
Will use step counts obtained from pedometer
Measured: Baseline, 16 week follow-up, 28 week follow-up
Secondary outcomes (1)
KIDSCREEN-27
Will look at Physical Well-Being (5 items), Parents and Autonomy (7 items), Social Support and Peers (4 items) and School Environment (4 items) subscales
Measured: Baseline, 16 week follow-up, 28 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study start2 Apr 2012
- Primary completion31 Mar 2018
- Study completion31 Mar 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 McMaster 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization, Ontario Brain Institute, The Ottawa Hospital Academic Medical Association
- Responsible party
- Sponsor
- Investigators
- Gabriel M Ronen, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550874
- Sponsor's protocol ID
- REB 12-035
- Acronym
- STEP
- Status last verified
- Jun 2018
- First submitted
- 8 Mar 2012
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STEP: Enhanced Physical Activity in Children and Youth With Epilepsy: Developing Evidence of Impacts on Health, Functioning, Psychological Wellbeing, and Quality of Life
- ClinicalTrials.gov ID
- NCT01550874
- Acronym / sponsor ID
- STEP / REB 12-035
- Conditions
- Epilepsy
- Keywords
- Physical Activity, Epilepsy, Children, Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization, Ontario Brain Institute, The Ottawa Hospital Academic Medical Association
- Study start
- 2 Apr 2012 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 12 Mar 2012 (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.
Epilepsy is common in childhood. Children with epilepsy are at increased risk of impaired health, functioning, psychological well-being, and quality of life. There is compelling evidence that physical activity improves the medical and psychosocial aspects of health in adults with epilepsy - but there are no such studies in children. This study is to see if increased levels of physical activity can influence children's functioning, psychological well-being, and quality of life.
Detailed description
There are many unfounded assumptions about the dangers of exercise in children with epilepsy - assumptions that may be seriously detrimental to children's health, and that we have good reason to challenge. This project explores the innovative idea that enhancing physical activity in children with epilepsy will have a positive effect on medical and psychosocial outcomes. The primary purpose of this study is to examine whether increasing physical activity levels through a six-month walking program, that includes behavioral counselling and self-monitoring of physical activity, as compared to varied un-standardized current practices, positively influences health and quality of life over one year. The secondary purposes are to (i) determine which environmental and personal facilitators and barriers to physical activity are experienced when increasing physical activity levels through a six-month walking program; (ii) determine if physical activity levels established during the six-month program will be sustained over a subsequent six-month period that includes self-monitoring of physical activity only; (iii) identify aspects of health that are amendable to change with enhanced physical activity, and explore the relationships among physical activity and impairments, functioning, psychological well-being and quality of life; and (iv) assess if there is a dose-response relationship between physical activity and a variety of health and social factors and quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Wear the pedometer provided by study everyday with weekly charging and syncing of data. |
| Experimental Group | Experimental | Behavioral: Physical activity behavior-change counsellingWear the pedometer provided by the study everyday and also participate in phone-based physical activity behavior-change counselling for 6 months and then check sustainability without further motivational support for another 6 months. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Has epilepsy, as confirmed by a pediatric neurologist, with at least 1 seizure in the previous 12 months
- Ambulatory
- Fluency English or French
- Intellectual functioning at or greater than grade 3 level, as judged by parents
- Access to a computer
Key exclusion criteria (2 listed)
- Additional diagnoses of psychogenic seizures or autism
- Enrolled in a potentially confounding trial
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 |
|---|---|---|
| Physical activity behavior-change counsellingParticipants in the experimental group will be motivated by augmented behavior modification strategies aiming to increase performance by: (i) having access to the pedometer web page that allows them to view their automatically calculated goals, and (ii) get feedback about performance toward goals. | Behavioural | Experimental Group |
Primary outcome
CHEQOL-25
Time frame: Baseline, 16 week follow-up, 28 week follow-up
Measure of quality of life
KIDSCREEN-27
Time frame: Baseline, 16 week follow-up, 28 week follow-up
Will look at Psychological Well-Being (7items) subscale
Step Count
Time frame: Baseline, 16 week follow-up, 28 week follow-up
Will use step counts obtained from pedometer
1 secondary outcome
KIDSCREEN-27
Time frame: Baseline, 16 week follow-up, 28 week follow-up
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 20 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Gabriel M Ronen, MD principal investigator
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity behavior-change counselling in people with Epilepsy, run by McMaster University at 2 sites in Canada.
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 5 inclusion and 2 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 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
CHEQOL-25 (time frame: Baseline, 16 week follow-up, 28 week follow-up). The study lists 3 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 20 Jun 2018; AzTrials last refreshed its copy on 6 Nov 2026.