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临床试验/NCT01550874
NCT01550874已完成不适用

STEP: Enhanced Physical Activity in Children and Youth With Epilepsy: Developing Evidence of Impacts on Health, Functioning, Psychological Wellbeing, and Quality of Life

McMaster University4 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2012年4月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
122
试验地点
4
主要终点
CHEQOL-25

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
8 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Has epilepsy, as confirmed by a pediatric neurologist, with at least 1 seizure in the previous 12 months
  • Ambulatory
  • Fluency English or French
  • Intellectual functioning at or greater than grade 3 level, as judged by parents
  • Access to a computer

排除标准

  • Additional diagnoses of psychogenic seizures or autism
  • Enrolled in a potentially confounding trial

研究组 & 干预措施

Control Group

No Intervention

Wear the pedometer provided by study everyday with weekly charging and syncing of data.

Experimental Group

Experimental

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.

干预措施: Physical activity behavior-change counselling (Behavioral)

结局指标

主要结局

CHEQOL-25

时间窗: Baseline, 16 week follow-up, 28 week follow-up

Measure of quality of life

KIDSCREEN-27

时间窗: Baseline, 16 week follow-up, 28 week follow-up

Will look at Psychological Well-Being (7items) subscale

Step Count

时间窗: Baseline, 16 week follow-up, 28 week follow-up

Will use step counts obtained from pedometer

次要结局

  • KIDSCREEN-27(Baseline, 16 week follow-up, 28 week follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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