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临床试验/NCT03236337
NCT03236337已完成不适用

Effectiveness of MOVI Interventions on Improving Adiposity, Cognition and Subclinical Atherosclerosis by Increasing Aerobic Cardiorespiratory Fitness: MOVI-daFit

University of Castilla-La Mancha4 个研究点 分布在 1 个国家目标入组 570 人开始时间: 2017年9月19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
发起方
入组人数
570
试验地点
4
主要终点
VO2 max

研究概览

简要总结

Project which objective is to test the effectiveness of an extracurricular physical activity intervention based on high intensity interval training (MOVI-daFit!) on improving cardiorespiratory fitness (CRF), cardiometabolic risk, executive function, and academic performance.

详细描述

In the last decade, this research group has tested the effectiveness of three interventions following this model. The first one (MOVI) was carried out in peripuberal age children (4th and 5th year of primary education, 8-11 years) and showed a moderate effect in reducing the adiposity of schoolchildren with higher BMI, an improvement of the lipid profile, without significantly improving the global cardiometabolic risk because it did not produce a reduction in insulinemia.

The second edition (MOVI-2), carried out at schoolchildren of the same age range, increased the duration and intensity of the sessions, and was focused on the development of muscular strength in order to improve insulinemia levels. The intervention showed proved effectiveness; in addition, the data from this intervention showed a modest improvement in girls' aerobic capacity, but not in boys.

The last edition (MOVI-KIDS) was aimed at children aged 4 to 7 years to test the hypotheses that vigorous physical activity at early ages could produce lifelong cardio-metabolic benefits. Data submitted for publication in this study show that, as in the case of the IDEFICS study in children of similar age, the intervention was not effective in improving fitness.

This new edition (MOVI-daFit!) has been designed as controlled cluster-randomized trial including 10 schools from Cuenca province, Spain. Five schools will be randomized to intervention group (IG), in which the intervention MOVI-daFit! will be conducted for children in fourth and fifth school grades (9-11 years old). The other five schools will be allocated to the control group (CG).

During an academic year the 4th and 5th schoolchildren allocated to IG will be carry out, in out of school hours, four times by week, one hour sessions of a standardized recreative, non competitive, physical activity intervention based on games adapted to high intensity interval training methodology (MOVI-daFit!). In the CG regular physical activity will continue.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • Schools must have at least one full classrooms for both the 4th and 5th grade of primary school.
  • The approval of boards of governors will be necessary.
  • Children's parents or legal representatives will sign an informed consent to participate.
  • Parents will be invited to collaborate by filling in questionnaires with regard to family leisure habits, sleeping, eating and getting around town.

排除标准

  • Severe Spanish language learning difficulties.
  • Serious physical or mental disorders identified by parents or teachers that would impede participation in the programme's activities.
  • Children diagnoses of chronic disorders, such as heart disease, diabetes or asthma, which in the opinion of their paediatricians would prevent their participation in the programme's activities (MOVI-daFit!).

研究组 & 干预措施

Control

No Intervention

No intervention

MOVI intervention

Experimental
  • MOVI-da Fit! is a high intensity interval training intervention that consists on: a) 4 h/week of a standardized recreative, non-competitive physical activity extracurricular program; and b) informative sessions to parents and teachers about how schoolchildren can became more active. It is aimed to enhance physical fitness, motor skills, physical activity time and active behaviours among 9-to-11 years old children.

干预措施: MOVI intervention (Behavioral)

结局指标

主要结局

VO2 max

时间窗: One year

It will be assessed by using 20-m shuttle run test, which is validated to measure maximal aerobic capacity in children from 5 years.

次要结局

  • Motor skills(One year)
  • Body fat%(One year)
  • Academic achievement(One year)
  • Executive function(One year)
  • Glucose profile(One year)
  • Health-related quality of life(One year)
  • Arterial Stiffness(One year)
  • Pulse wave velocity(One year)
  • Ultrasensitive protein profile(One year)
  • Lipid profile(One year)
  • Sleep behaviors and sleep problems by questionnaire(One year)
  • BDNF blood determination(One year)
  • Sleep quality by accelerometry(One year)
  • Physical activity(One year)
  • Subclinical atherosclerosis(One year)
  • Insulin profile(One year)

研究者

发起方
University of Castilla-La Mancha
申办方类型
Other
责任方
Sponsor

研究点 (4)

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