STEP: Enhanced Physical Activity in Children and Youth With Epilepsy
- Conditions
- Epilepsy
- Interventions
- Behavioral: Physical activity behavior-change counselling
- Registration Number
- NCT01550874
- Lead Sponsor
- McMaster University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
- 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
- Additional diagnoses of psychogenic seizures or autism
- Enrolled in a potentially confounding trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Group Physical activity behavior-change counselling 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.
- Primary Outcome Measures
Name Time Method CHEQOL-25 Baseline, 16 week follow-up, 28 week follow-up Measure of quality of life
KIDSCREEN-27 Baseline, 16 week follow-up, 28 week follow-up Will look at Psychological Well-Being (7items) subscale
Step Count Baseline, 16 week follow-up, 28 week follow-up Will use step counts obtained from pedometer
- Secondary Outcome Measures
Name Time Method KIDSCREEN-27 Baseline, 16 week follow-up, 28 week follow-up 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
Trial Locations
- Locations (2)
McMaster Children's Hospital
🇨🇦Hamilton, Ontario, Canada
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada