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Clinical Trials/NCT01550874
NCT01550874
Completed
Not Applicable

STEP: Enhanced Physical Activity in Children and Youth With Epilepsy: Developing Evidence of Impacts on Health, Functioning, Psychological Wellbeing, and Quality of Life

McMaster University2 sites in 1 country122 target enrollmentApril 2, 2012
ConditionsEpilepsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsy
Sponsor
McMaster University
Enrollment
122
Locations
2
Primary Endpoint
CHEQOL-25
Status
Completed
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
April 2, 2012
End Date
March 31, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • KIDSCREEN-27(Baseline, 16 week follow-up, 28 week follow-up)

Study Sites (2)

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