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

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physical activity behavior-change counselling
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Epilepsy focused on measuring Physical Activity, Epilepsy, Children, Motivation

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McMaster Children's Hospital
  • Children's Hospital of Eastern Ontario

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Experimental Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

CHEQOL-25
Measure of quality of life
KIDSCREEN-27
Will look at Psychological Well-Being (7items) subscale
Step Count
Will use step counts obtained from pedometer

Secondary Outcome Measures

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

Full Information

First Posted
March 8, 2012
Last Updated
June 19, 2018
Sponsor
McMaster University
Collaborators
Hamilton Academic Health Sciences Organization, Ontario Brain Institute, The Ottawa Hospital Academic Medical Association
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1. Study Identification

Unique Protocol Identification Number
NCT01550874
Brief Title
STEP: Enhanced Physical Activity in Children and Youth With Epilepsy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 2, 2012 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
March 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Hamilton Academic Health Sciences Organization, Ontario Brain Institute, The Ottawa Hospital Academic Medical Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Physical Activity, Epilepsy, Children, Motivation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Wear the pedometer provided by study everyday with weekly charging and syncing of data.
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity behavior-change counselling
Intervention Description
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.
Primary Outcome Measure Information:
Title
CHEQOL-25
Description
Measure of quality of life
Time Frame
Baseline, 16 week follow-up, 28 week follow-up
Title
KIDSCREEN-27
Description
Will look at Psychological Well-Being (7items) subscale
Time Frame
Baseline, 16 week follow-up, 28 week follow-up
Title
Step Count
Description
Will use step counts obtained from pedometer
Time Frame
Baseline, 16 week follow-up, 28 week follow-up
Secondary Outcome Measure Information:
Title
KIDSCREEN-27
Description
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
Time Frame
Baseline, 16 week follow-up, 28 week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel M Ronen, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

STEP: Enhanced Physical Activity in Children and Youth With Epilepsy

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