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Completed

NCT Number: NCT01550874

STEP: Enhanced Physical Activity in Children and Youth With Epilepsy

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.

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Key information

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster Children's Hospital, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity behavior-change counselling

Behavioral

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.

Primary outcomes

  1. CHEQOL-25

    Time frame: Baseline, 16 week follow-up, 28 week follow-up

    Measure of quality of life

  2. KIDSCREEN-27

    Time frame: Baseline, 16 week follow-up, 28 week follow-up

    Will look at Psychological Well-Being (7items) subscale

  3. Step Count

    Time frame: Baseline, 16 week follow-up, 28 week follow-up

    Will use step counts obtained from pedometer

Secondary outcomes

  1. KIDSCREEN-27

    Time frame: 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

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Hamilton Academic Health Sciences Organization
  • Ontario Brain Institute
  • The Ottawa Hospital Academic Medical Association

Registry information

Official study title

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

Acronym: STEP

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Mar 12, 2012
Registry last updated
Jun 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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