Clinical trial NCT01550874: STEP: Enhanced Physical Activity in Children and Youth With Epilepsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: Physical Activity
Epilepsy
Children
Motivation
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Hamilton Academic Health Sciences Organization
name: Ontario Brain Institute
name: The Ottawa Hospital Academic Medical Association
First posted: 2012-03-12
Enrollment: 122
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: CHEQOL-25
timeFrame: Baseline, 16 week follow-up, 28 week follow-up
measure: KIDSCREEN-27
timeFrame: Baseline, 16 week follow-up, 28 week follow-up
measure: Step Count
timeFrame: Baseline, 16 week follow-up, 28 week follow-up
Secondary outcomes:
measure: KIDSCREEN-27
timeFrame: Baseline, 16 week follow-up, 28 week follow-up
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
affiliation: McMaster University
name: Gabriel M Ronen, MD
role: PRINCIPAL_INVESTIGATOR
References: