STEP: Enhanced Physical Activity in Children and Youth With Epilepsy

Study Overview
=================
Brief 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 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.

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

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Behavioral: Physical activity behavior-change counselling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Additional diagnoses of psychogenic seizures or autism Enrolled in a potentially confounding trial

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Wear the pedometer provided by study everyday with weekly charging and syncing of data. | |
| Experimental: Experimental Group<br>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. | Behavioral: Physical activity behavior-change counselling<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHEQOL-25 | Measure of quality of life | Baseline, 16 week follow-up, 28 week follow-up | 
| KIDSCREEN-27 | Will look at Psychological Well-Being (7items) subscale | Baseline, 16 week follow-up, 28 week follow-up | 
| Step Count | Will use step counts obtained from pedometer | Baseline, 16 week follow-up, 28 week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, 16 week follow-up, 28 week follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical Activity, Epilepsy, Children, Motivation