Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Enhanced Physical Activity in Sedentary Children and Youth With Epilepsy

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by McMaster University
Sponsor:
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01550874
First received: March 8, 2012
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

Hypothesis: The investigators hypothesize that a pedometer-based motivated 6-months walking program will result in sustainable enhanced PA.


Condition Intervention
Physical Activity
Epilepsy
Seizures
Children
Motivation
Behavioral: Motivation

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Enhanced Physical Activity in Sedentary Children and Youth With Epilepsy: Developing Evidence of Impacts on Health, Functioning, Psychological Wellbeing and Quality of Life

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Quality of Life (CHEQOL-25) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Control Group
Sedentary children with epilepsy will maintain step count for 6 months and then be asked to increase the step count.
Experimental Group
Sedentary Children with epilepsy, increase the step count weekly with motivational strategies for 6 months and then check sustainability without further motivational support for another 6 months.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   8 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

(i) ages of 8 - 14 years; (ii) active epilepsy as confirmed by a pediatric neurologist with at least 1 seizures in the previous year; (iii) must be ambulatory; (iv) understands English; (v) function at a grade 3 level as judged by parents; (vi) not participate in any copetitive physical sports; (vii) able and willing to complete the web-based questionnaires

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550874

Contacts
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

Locations
Canada, Ontario
McMaster Children's Hospital and Children's Hospital of Eastern Ontario Recruiting
Hamilton and Ottawa, Ontario, Canada, L8S 4K1
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   
Principal Investigator: Ronen M. Ronen, MD         
Sub-Investigator: Brian Timmons, PHD         
Sub-Investigator: David Streiner, PHD         
Sub-Investigator: Steven Bray, PHD         
Sub-Investigator: Peter Rosenbaum, MD         
Principal Investigator: Daniela Pohl, MD, PhD         
Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: Gabriel M Ronen, MD McMaster University
  More Information

No publications provided

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01550874     History of Changes
Other Study ID Numbers: REB 12-035
Study First Received: March 8, 2012
Last Updated: December 3, 2012
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by McMaster University:
Physical Activity
Epilepsy
Children

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

ClinicalTrials.gov processed this record on November 25, 2014