STEP: Enhanced Physical Activity in Children and Youth With Epilepsy

Epilepsy Clinical Trial

— STEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01550874
• Other study ID #: REB 12-035
• Status: Completed
• Phase: N/A
• Start date: April 2, 2012
• Est. completion date: March 31, 2018

Study information

• Verified date: June 2018
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

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.

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	Ontario
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
McMaster University	Hamilton Academic Health Sciences Organization, Ontario Brain Institute, The Ottawa Hospital Academic Medical Association

Country where clinical trial is conducted

Canada, 

Outcome

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