Enhancing Physical Activity Levels in Children With Epilepsy

Epilepsy Clinical Trial

Official title:

Enhancing Physical Activity in Children With Epilepsy: Impacts on Health and Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01889901
• Other study ID #: 12/13E
• Status: Completed
• Phase: N/A
• First received: February 19, 2013
• Last updated: March 2, 2016
• Start date: December 2012
• Est. completion date: May 2015

Study information

• Verified date: March 2016
• Source: Children's Hospital of Eastern Ontario
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Research Ethics Board, Children's Hospital of Eastern Ontario
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 14 Years

Eligibility

Inclusion Criteria:

• Participants are between 8-14 years of age

• Participants are required to have epilepsy, as confirmed by a pediatric neurologist with at least 1 seizure in the previous 12 months

• Participants must be ambulatory

• Participants and parents must understand English or French

• Participants must function at a =grade 3 level as judged by parents

• Participants must be able and willing to complete the questionnaires

Exclusion Criteria:

• Participants who cannot ambulate independently

• Participants who are not permitted to participate in the physical education class at school

• Participants with uncontrolled and frequent seizures who will not be supervised when undergoing physical activity

• Participants with a family history of sudden cardiac arrest or of sudden unexplained death in a family member younger than 50 years of age

Study Design

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Behavioral:
• Enhanced walking program
The goal is to reach 12,000 steps per day by the end of the 6-month intervention period. If 12,000 steps per day are reached, participants will be encouraged to surpass this goal or to maintain this step count. Participants will be motivated by augmented behavior modification strategies such as: having access to the pedometer web page to view calculated step counts; scanning and discussing neighborhoods for available walking routes; and creating a buddy system for walking. Each will be facilitated by telephone-based physical activity behavior change counselling, occurring weekly, bi-weekly and monthly. Participants will upload their pedometer data wirelessly. At the end of the 6 months, the experimental group will be monitored for an additional 24 weeks with no further incentives.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Eastern Ontario	McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Facilitators and Barriers to Physical Activity in Children with Epilepsy	Children's assessment of participation and enjoyment (CAPE) - Facilitators and barriers for children with epilepsy & exercise; and Self-perception profile - Looks at child/adolescent perceived competence; Children's self-perceptions of adequacy and predilection for physical activity (CSAPPA) - self perceptions of adequacy and desire to participate in physical activities.	0, 16, 28 and 54 weeks	No
Other	Canadian Assessment of Physical Literacy - CAPL	The CAPL tests require children to complete physical activity exercises (i.e. obstacle course, plank, grip strength, etc.). and questionnaires designed to assess children's knowledge, interests and skills related to physical activity.	Baseline (0-2 weeks)	No
Primary	Quality of Life	KidScreen: Psychological Well-Being and mood; and Health-Related Quality of Life in Childhood Epilepsy: Quality of life.	0, 16, 28 and 54 weeks	No
Secondary	Physical Health	Step count (calculated with Fitbit® pedometer); Body mass index (BMI) to estimate overweight and obesity; Blood pressure; Seizure Severity Scale; and Drug Toxicity Scale; Demographic Questions.	0, 16, 28 and 54 weeks	No
Secondary	Mental Health and Social Impact	Childhood depression index; Multidimensional anxiety scale for children; Social support scale for children; Parental stress index; Parent response to child illness scale; Externalizing behavior - Examines children's attention, conduct and cooperativeness; Children's assessment of participation and enjoyment (CAPE) - Facilitators and barriers for children with epilepsy & exercise; Self-perception profile - Looks at child/adolescent perceived competence; Children's self-perceptions of adequacy and predilection for physical activity (CSAPPA) - self perceptions of adequacy and desire to participate in physical activities.	0, 16, 28 and 54	No