STEP: Enhanced Physical Activity in Children and Youth With Epilepsy

NCT01550874 | Completed

• 1 other identifier: REB 12-035
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 2

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.

Conditions

Epilepsy

Keywords

Physical Activity; Epilepsy; Children; Motivation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• KIDSCREEN-27

  Baseline, 16 week follow-up, 28 week follow-up

Study Arms (2)

Control Group

NO INTERVENTION

Wear the pedometer provided by study everyday with weekly charging and syncing of data.

Experimental Group

EXPERIMENTAL

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

Interventions

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.

Experimental Group

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Additional diagnoses of psychogenic seizures or autism
• Enrolled in a potentially confounding trial

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Academic Health Sciences Organization: collaborator
• Ontario Brain Institute: collaborator
• The Ottawa Hospital Academic Medical Association: collaborator

Study Sites (2)

McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

MeSH Terms

Conditions

Epilepsy; Motor Activity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Study Officials

• Gabriel M Ronen, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: March 12, 2012
• Study Start: April 2, 2012
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: June 20, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)