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临床试验/NCT03647007
NCT03647007已完成不适用

Evidence of the Short- and Long-term Effects of a Residential Stay in a Danish Christmas Seal Home - With and Without a High-intensity Activity/Health Education (FIFA 11 for Health) Programme.

University of Southern Denmark4 个研究点 分布在 1 个国家目标入组 614 人开始时间: 2018年9月11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
614
试验地点
4
主要终点
changes in overweight

研究概览

简要总结

The purpose of the study is: (1) to evaluate the short-term effects of a 10-week residential stay in a Danish Christmas Seal Home on health, physical fitness, physical activity level, learning, sleep and well-being; (2) to investigate the long-term effects 3 and 12 months after the stay; and (3) to examine whether a special effort involving a high-intensity activity/health education programme (FIFA 11 for Health) increases the effects on physical fitness and health knowledge, learning capabilities, sleep patterns, well-being and adherence to a physically active lifestyle compared to the standard programme.

详细描述

Design Approx. 600 boys and girls aged 7-14 years are recruited from two Danish Cristmas Seal Homes (DCSHs) during 2018-2020. The design is a cross-over design at DCSH level over a two-year period with two intervention groups: a standard group (with the standard programme (SG)) and a standard + FIFA group (SG+). In SG+, the children, in addition to the standard programme, play recreational football for 2x45 min a week. In SG, the children perform the activities according to the regular schedule. In SG+, consist of different football exercises (dribbling, ball control, passing, etc.) and small-sided games with high intensity (3v3 to 5v5) using two goals. Every week, a specific football skill is linked to a health message, e.g. the skill of passing the ball to one another is linked to mutual respect and avoiding bullying.

Training protocol Recreational football The risk of injury for young players is markedly higher (5 times higher) in football match-play than in football training. While it is noted that muscle strains and twisting injuries in joints can also occur during training with small goals, the injury frequency for 10-year-old children in football training is approx. 5 per 1,000 training sessions, and hence low. Furthermore, the FIFA 11 for Health pilot study, which involved Danish 10-11-year-old schoolchildren, did not record any injuries during the training.

Tests and measurements The participants are tested at the start and end of their 10-week residential stay at the DCSH. Furthermore, there are follow-up tests 3 and 12 months after their stay. The four test days include measurements of physical fitness, physical performance, cognitive functions and questionnaires about health knowledge, well-being and sleep patterns. For further descriptions, see below.

Each test day, lasting approx. 4-5 hours, is planned in collaboration with DCSH staff and implemented by a member of the scientific group (human physiologists).

Anthropometric measurements: Body weight and standing and sitting height are measured using a portable body composition analyser (InBody 720) and an altimeter, respectively. The InBody 720 also provides an estimate of muscle mass and fat percentage. After a minimum of 10 min of resting in the supine position in a quiet room, measurements of resting heart rate and blood pressure are performed.

研究设计

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

入排标准

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

入选标准

  • • Boys and girls aged 7-14 years undergoing a 10-week DCSH residential stay.
  • Informed consent from parents/legal guardian.
  • Willingness to participate in training and testing.

排除标准

  • • Participants found by the researchers to be unsuited to following the procedures of the protocol and the training and testing programme.

研究组 & 干预措施

Standard group

No Intervention

The Standard programme on the Christmas Seal Homes.

FIFA Group

Experimental

The Standard programme including FIFA 11 for Health programme - health knowledge on the football pitch.

干预措施: FIFA 11 for health (Other)

结局指标

主要结局

changes in overweight

时间窗: baseline, 10 weeks, follow-up - 3 and 12 months

measurements of fat percentage, portable body composition analyser (InBody 720)

次要结局

  • health knowledge, questionnaires(baseline, 10 weeks, follow-up - 3 and 12 months)
  • well-being, questionnaires(baseline, 10 weeks, follow-up - 3 and 12 months)
  • BMI z-scores(baseline, 10 weeks, follow-up - 3 and 12 months)
  • aerobic fitness, measured with Andersen running test(baseline, 10 weeks, follow-up - 3 and 12 months)

研究者

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

Peter Krustrup

Professor

University of Southern Denmark

研究点 (4)

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