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STEP: Enhanced Physical Activity in Children and Youth With Epilepsy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01550874
Acronym
STEP
Enrollment
122
Registered
2012-03-12
Start date
2012-04-02
Completion date
2018-03-31
Last updated
2018-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Physical Activity, Epilepsy, Children, Motivation

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.

Interventions

BEHAVIORALPhysical 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.

Sponsors

Hamilton Academic Health Sciences Organization
CollaboratorOTHER
Ontario Brain Institute
CollaboratorOTHER
The Ottawa Hospital Academic Medical Association
CollaboratorOTHER
McMaster University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
CHEQOL-25Baseline, 16 week follow-up, 28 week follow-upMeasure of quality of life
KIDSCREEN-27Baseline, 16 week follow-up, 28 week follow-upWill look at Psychological Well-Being (7items) subscale
Step CountBaseline, 16 week follow-up, 28 week follow-upWill use step counts obtained from pedometer

Secondary

MeasureTime frameDescription
KIDSCREEN-27Baseline, 16 week follow-up, 28 week follow-upWill look at Physical Well-Being (5 items), Parents and Autonomy (7 items), Social Support and Peers (4 items) and School Environment (4 items) subscales

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026