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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 : Recruiting
First Posted : March 12, 2012
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):

March 8, 2012
March 12, 2012
September 23, 2015
April 2012
March 2017   (Final data collection date for primary outcome measure)
Quality of Life (CHEQOL-25) [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT01550874 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
Hypothesis: The investigators hypothesize that a pedometer-based motivated 6-months walking program will result in sustainable enhanced PA.
Enhanced PA will in turn positively influence health, social participation and QoL of sedentary CWE through multiple pathways. These will involve biomedical factors (i.e. attention deficit, depression, anxiety and sleep disorders); and contextual environmental and personal factors that include psychosocial factors at the child, family and community level (Figure 1).21 These factors may include family stressors, social support, self-efficacy, and autonomy.22 We expect that enhanced, sustained PA will improve health, functioning and QoL of CWE through its potential neuroprotective and circadian rhythm regulatory effects, and by increasing social participation, promoting a positive outlook on life and self-image, decreasing worries and concerns, decreasing emotional problems and the concealment of epilepsy, and delaying secondary health complications.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
  • Physical Activity
  • Epilepsy
  • Seizures
  • Children
  • Motivation
Behavioral: Motivation
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 get feedback about performance toward goals
  • No Intervention: Control Group
    Sedentary children with epilepsy will maintain step count for 6 months and then be asked to increase the step count.
  • Experimental: Experimental Group
    Sedentary Children with epilepsy, increase the step count weekly with phon-based motivational coaching strategies for 6 months and then check sustainability without further motivational support for another 6 months.
    Intervention: Behavioral: Motivation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
March 2018
March 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • ages of 8 - 14 years
  • has epilepsy, as confirmed by a pediatric neurologist with at least 1 seizures in the previous 12 months
  • must be ambulatory; (iv) understands English or French
  • functions at a grade 3 level as judged by parents
  • not involved in regular competitive physical sports
  • able and willing to complete the web-based questionnaires.

Exclusion Criteria:

  • anyone not between ages of 8 and 14
  • patient must have epilepsy
  • unable to walk
  • non english or french speaking
  • functioning below a grade 3 level
  • already involved in regular physical activity
  • unable to complete web-based questionnaires
Sexes Eligible for Study: All
8 Years to 14 Years   (Child)
No
Contact: Gabriel M Ronen, MD 905-521-2100 ext 73392 roneng@mcmaster.ca
Contact: Sarah L Mitchell 905-521-2100 ext 73392 smitch@mcmaster.ca
Canada
 
 
NCT01550874
REB 12-035
No
Not Provided
Not Provided
McMaster University
McMaster University
Not Provided
Principal Investigator: Gabriel M Ronen, MD McMaster University
McMaster University
September 2015

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