We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01550874
Recruitment Status : Active, not recruiting
First Posted : March 12, 2012
Last Update Posted : February 2, 2018
Sponsor:
Collaborators:
Hamilton Academic Health Sciences Organization
Ontario Brain Institute
The Ottawa Hospital Academic Medical Association
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment
Epilepsy Behavioral: Physical activity behavior-change counselling

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : April 2, 2012
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control Group
Wear the pedometer provided by study everyday with weekly charging and syncing of data.
Experimental: Experimental Group
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
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 Measures :
  1. CHEQOL-25 [ Time Frame: Baseline, 16 week follow-up, 28 week follow-up ]
    Measure of quality of life

  2. KIDSCREEN-27 [ Time Frame: Baseline, 16 week follow-up, 28 week follow-up ]
    Will look at Psychological Well-Being (7items) subscale

  3. Step Count [ Time Frame: Baseline, 16 week follow-up, 28 week follow-up ]
    Will use step counts obtained from pedometer


Secondary Outcome Measures :
  1. KIDSCREEN-27 [ Time Frame: Baseline, 16 week follow-up, 28 week follow-up ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has epilepsy, as confirmed by a pediatric neurologist, with at least 1 seizure in the previous 12 months
  • Ambulatory
  • Fleuncy 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550874


Locations
Canada, Ontario
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8S 4K1
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Sponsors and Collaborators
McMaster University
Hamilton Academic Health Sciences Organization
Ontario Brain Institute
The Ottawa Hospital Academic Medical Association
Investigators
Principal Investigator: Gabriel M Ronen, MD McMaster University

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01550874     History of Changes
Other Study ID Numbers: REB 12-035
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by McMaster University:
Physical Activity
Epilepsy
Children
Motivation

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases