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

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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

March 8, 2012
March 12, 2012
February 2, 2018
April 2, 2012
March 31, 2018   (Final data collection date for primary outcome measure)
  • CHEQOL-25 [ Time Frame: Baseline, 16 week follow-up, 28 week follow-up ]
    Measure of quality of life
  • KIDSCREEN-27 [ Time Frame: Baseline, 16 week follow-up, 28 week follow-up ]
    Will look at Psychological Well-Being (7items) subscale
  • Step Count [ Time Frame: Baseline, 16 week follow-up, 28 week follow-up ]
    Will use step counts obtained from pedometer
Quality of Life (CHEQOL-25) [ Time Frame: 1 year ]
Complete list of historical versions of study NCT01550874 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
STEP: Enhanced Physical Activity in Children and Youth With Epilepsy
STEP: Enhanced Physical Activity in Children and Youth With Epilepsy: Developing Evidence of Impacts on Health, Functioning, Psychological Wellbeing, and Quality of Life
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Epilepsy
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.
  • 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.
    Intervention: Behavioral: Physical activity behavior-change counselling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
122
200
March 31, 2018
March 31, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
8 Years to 14 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01550874
REB 12-035
No
Not Provided
Plan to Share IPD: No
McMaster University
McMaster University
  • Hamilton Academic Health Sciences Organization
  • Ontario Brain Institute
  • The Ottawa Hospital Academic Medical Association
Principal Investigator: Gabriel M Ronen, MD McMaster University
McMaster University
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP