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临床试验/NCT03255499
NCT03255499Unknown不适用

Efficacy of the MovinCog Intervention in Children: A Randomized, Placebo-controlled Trial

University of Auckland, New Zealand2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2017年9月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
2
主要终点
Change from baseline working memory capacity at 10 weeks

研究概览

简要总结

This study aims to test the efficacy of the MovinCog Intervention to enhance cognitive abilities in children 7-15 yrs. The intervention consists of two parts: a physical exercise regimen, based on high-intensity training, and a cognitive training component. The design will contrast the intervention with an active control group, matched for expectancy effects.

详细描述

Specifically, the investigators will compare both components together (exercise and cognitive training) against either one of the components (exercise alone, or cognitive training alone) and against an active control group. The study will include measures of scholastic aptitude, as well as of working memory and cognitive control (primary outcome measures), two cognitive abilities that are critical to daily life activities, and that respond well to training. In addition, the investigators will measure physiological responses to training, to monitor changes associated with exercise (secondary outcome measures). Finally, the investigators will relate training-specific improvements with transfer gains, to better model the interaction between training and transfer. This will provide a comprehensive understanding of the dynamics associated with the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
7 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Age outside inclusion criteria
  • History of seizures, brain trauma

结局指标

主要结局

Change from baseline working memory capacity at 10 weeks

时间窗: Baseline and 10-week posttest

Constructs measured by multiple tasks (bds, corsi, n-back)

Change from baseline cognitive control at 10 weeks

时间窗: Baseline and 10-week posttest

Constructs measured by multiple tasks (flanker, go/no-go, stroop)

Change from baseline scholastic aptitude at 10 weeks

时间窗: Baseline and 10-week posttest

Constructs measured by multiple national (New Zealand), standardized tests

次要结局

  • BDNF polymorphism measured by genetic saliva kit(Baseline)
  • Change from baseline resting heart rate at 10 weeks(Baseline and 10-week posttest)

研究者

发起方
University of Auckland, New Zealand
申办方类型
Other
责任方
Principal Investigator
主要研究者

David Moreau

PhD

University of Auckland, New Zealand

研究点 (2)

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