Enhancing Physical Activity Levels in Children With Epilepsy

Status Completed

Clinical Trial Summary

Epilepsy is common in childhood. Throughout life, including adulthood, children with epilepsy are at increased risk of impaired health, functioning, psychological well-being and quality-of-life. There is evidence that physical activity improves the medical and psychosocial aspects of health in adults with epilepsy- but there are no such studies in children. The investigators predict that we can increase levels of physical activity and influence children's functioning, psychological well-being and quality of life through multiple pathways. The investigators propose to evaluate the relationship between enhanced physical activity and health, and explore facilitators and barriers to physical activity in children with epilepsy.

Clinical Trial Description

This project explores an innovative idea that, if successful, will have the potential to significantly change current thinking and practice regarding health promotion among children with epilepsy. There are many unfounded assumptions about the dangers of exercise in children with epilepsy that may be seriously detrimental to children's health, and that we have good reason to challenge. Physical activity (PA) interventions, such as walking programs, are practicable, non-pharmacological approaches to health promotion and represent a neglected opportunity for disease modification. We propose to undertake a prospective randomized controlled trial to evaluate the effects of increasing physical activity levels through a modern pedometer-measured walking program, followed by assessment of the sustainability of the program. We hypothesize that a motivational program to increase the levels of PA over 6-months will result in sustainable enhanced PA. This in turn will positively and simultaneously influence health and reduce several morbidities in children with epilepsy, leading to improved health and life quality in childhood and continuing into adulthood. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Epilepsy

Clinical Trial Details

NCT number	NCT01889901
Study type	Interventional
Source	Children's Hospital of Eastern Ontario
Contact
Status	Completed
Phase	N/A
Start date	December 2012
Completion date	May 2015

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.