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临床试验/NCT02227095
NCT02227095已完成不适用

Exercise & Overweight Children's Cognition

Augusta University2 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2008年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
175
试验地点
2
主要终点
Change in functional MRI

研究概览

简要总结

This research focuses on overweight, sedentary children whose health, cognition, and academic performance are therefore at risk, and who may be particularly responsive to exercise interventions.

This study will determine whether regular exercise per se (i.e. compared to attention control, or placebo, condition) benefits children's cognition and achievement, and will provide insight into neural mechanisms. A substudy will examine exercise-induced changes in brain structure.

Provision of comprehensive evidence for the benefits of exercise on children's health may reduce barriers to vigorous physical activity programs during a childhood obesity epidemic by persuading policymakers, schools and communities that time spent in physical activity enhances, rather than detracts from, learning.

详细描述

An ancillary study adding cardiometabolic outcome measures was added (R01HL087923-02S1, http://projectreporter.nih.gov/project_info_description.cfm?aid=7880457\&icde=20104167)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
8 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 8-11 years of age
  • Overweight or obese (BMI-for-age >= 85th percentile)
  • Able to participate in exercise testing and intervention

排除标准

  • Medical condition or medications that would interfere with measurements
  • Participation in weight control or formal exercise program outside physical education that meets more than 1 day/week
  • T-score > 75 on the BRIEF Behavior Regulation scale to avoid program disruption

结局指标

主要结局

Change in functional MRI

时间窗: Baseline, 8 months

Change in blood-oxygenation level dependent (BOLD) signal reflecting brain activation during executive function tasks

Change in Planning Scale scores

时间窗: Baseline, 8 months, one-year follow-up

The Cognitive Assessment System provides an individually administered standardized psychological assessment of executive function

次要结局

  • Change in aerobic fitness(Baseline, 8 months, one-year follow-up)
  • Change in BMI(Baseline, 8 months, one-year follow-up)
  • Change in adiposity(Baseline, 8 months, one-year follow-up)
  • Change in teacher ratings of classroom behavior(Baseline, 8 months)
  • Change in academic achievement(Baseline, 8 months, one-year follow-up)
  • Change in performance on executive function tasks(Baseline, 8 months)
  • Change in Tower of London scores(Baseline, 8 months, one-year follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catherine Davis

Professor of Pediatrics, Physiology & Graduate Studies

Augusta University

研究点 (2)

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