STEP: Enhanced Physical Activity in Children and Youth With Epilepsy (STEP)

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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Behavioral: Physical activity behavior-change counselling

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.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • McMaster Children's Hospital
    • Ottawa, Ontario, Canada, K1H 8L1
      • Children's Hospital of Eastern Ontario

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Wear the pedometer provided by study everyday with weekly charging and syncing of data.
Experimental: Experimental Group; 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.	Behavioral: Physical activity behavior-change counselling; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CHEQOL-25	Measure of quality of life	Baseline, 16 week follow-up, 28 week follow-up
KIDSCREEN-27	Will look at Psychological Well-Being (7items) subscale	Baseline, 16 week follow-up, 28 week follow-up
Step Count	Will use step counts obtained from pedometer	Baseline, 16 week follow-up, 28 week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KIDSCREEN-27	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	Baseline, 16 week follow-up, 28 week follow-up

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: The Ottawa Hospital Academic Medical Association; Hamilton Academic Health Sciences Organization; Ontario Brain Institute
• Investigators: Principal Investigator: Gabriel M Ronen, MD, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2012
• Primary Completion (Actual): March 31, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: March 8, 2012
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (Estimate): March 12, 2012

Study Record Updates

• Last Update Posted (Actual): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Epilepsy; Physical Activity; Children; Motivation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: REB 12-035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO