Enhanced Physical Activity in Sedentary Children and Youth With Epilepsy
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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 |
- 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.
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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.
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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
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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 |
(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
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| 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, 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 | |
| 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 Seizures Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013